Document KJ14aeMqvkpqB6dVOor5243m6

SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Uses and substitutions of Specialist Equipment This document is the appendix of the general comment to the Restriction report on Per- and polyfluoroalkyl substances (PFAS) from SEAJ (Semiconductor Equipment Association of Japan). submitted on 12th.September 2023 1 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Table of content The characteristics and functions of PFAS ...................................................................................3 Summary ....................................................................................................................................3 Chemical resistance ..................................................................................................................3 Ozone resistance .......................................................................................................................4 Repellency from water and oil / non-adhesion ..........................................................................5 Heat resistance ..........................................................................................................................6 Electric insulation .......................................................................................................................6 Low friction, self lubrication .......................................................................................................7 Gas barrier properties/Gas permeation properties....................................................................8 Low refractive index .................................................................................................................10 Weatherability ..........................................................................................................................11 Durability ..................................................................................................................................12 Resistance to creep / Compression set...................................................................................12 Uses of PFAS in Specialist Equipment .......................................................................................14 Summary ..................................................................................................................................14 electric wires and insulation.....................................................................................................15 Heat shrink tubing ....................................................................................................................18 Sealing materials .....................................................................................................................18 Plumbing ..................................................................................................................................24 Valves .......................................................................................................................................27 Pumps ......................................................................................................................................34 Coating/Lining ..........................................................................................................................34 Membrane filters ......................................................................................................................40 Optical coating .........................................................................................................................44 Heat medium............................................................................................................................50 Lubricating oil...........................................................................................................................51 Others ......................................................................................................................................54 2 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan The characteristics and functions of PFAS Summary PFASs have many functions. The characteristics and functions of PFAS which are mainly used in Specialist equipment are described in this section. PFAS has excellent properties such as, chemical resistance, electric insulation, heat resistance, repellency from water and oil, non-adhesion, weatherability, and others. PFASs are used where multiple of these properties are required simultaneously. We recognize that the ability to provide these various properties in a single material is the most important property of PFAS, and at present we do not have information on any other substance with this function other than PFAS. Chemical resistance Fluoropolymers compared to other general-purpose resins Table 1 Classes of Substances at 20 C, Chemical Compatibility Chart - LDPE, HDPE, PP, Teflon Resistance (calpaclab.com) 1 * Not for tubing chemical resistance (except PVC) ** Except for oxidizing acids (See oxidizing agents, strong) *** TPE gaskets Excellent: 30 days of constant exposure causes no damage. Plastic may tolerate for 30 years. Good: Little or no damage after 30 days of constant exposure for the regent Fair: Some effect after 7 days of constant exposure to the reagent. The effect may be crazing, cracking, loss of strength or discoloration. Not recommended: Immediate damage may occur. Depending on the plastic, the effect may be severe crazing, cracking, loss of strength or dis coloration, deformation, dissolution or permeation loss. 3 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Table 2 Property Comparison of Fluoroelastomers (FKM) with Other Rubbers1 : Excellent : Good : Fair : Marginal : Poor "Cleanliness" is defined as the fact that fluoropolymers are not easily eluted by acids, alkalis, or solvents (chemical resistance), do not contain other materials such as plasticizers in the molding process, and do not contain products that would thermally decompose during the material molding process. Ozone resistance Ozone is known to degrade plastic materials in two ways: A: Substances with double bonds (C=C) in their structures (such as natural rubber, chloroprene rubber, butadiene rubber, etc.) undergo decomposition in which ozone reacts with the double bonds to produce ketones, when they come into contact with ozone. B: When ozone exists in water, peroxy radicals are generated. Non-fluorine materials (eg polyethylene, polypropylene, etc.) deteriorate even if they do not have double bonds. Fluoropolymers does not have decomposition pathways such as A and B even if it comes into contact with ozone, so it can be used for a long time without deterioration. 1 https://www.daikinchemicals.com/library/pb_common/pdf/catalog/RC-1L.pdf translated from the document in Japanese. Last accessed on 14 July, 2023 4 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Thermoplastic resin Ozon Resistance Soft vinyl chloride PVC Rigid vinyl chloride PVC Vinylidene chloride resin PVdC ABS ABS Polyethylene PE Nylon N Acrylic resin PMMA Fluoropolymer resin PTFE Phenolic resin PF Melamine resin PVC Furan resin FF Epoxy resin EP Unsaturated polyester resin UP Table 3 Comparison of ozone resistance properties of plastics Repellency from water and oil / non-adhesion Since the fluoropolymers have a small polarizability, the intermolecular force is small. Because of its characteristics, fluoropolymers have repellency and non-adhere properties on the surface. In general, the repellency from various liquids is evaluated by the contact angle, and the larger the contact angle, the higher the repellency. Contact angle Figure 1 Contact angles with water Adhesion energy refers to the amount of work required to pull a liquid contacting a solid away from the solid. The larger the contact angle, the smaller the adhesion energy. It means that a 5 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan liquid in contact with a small adhesion energy solid easy to separate from the solid.2 Material name Contact angle with water (o) PTFE 114 FEP 115 Silicone resin 90~110 Paraffin 105~106 PE 88 PCTFE 83 PA 77 Phenolic resin 60 Copper(electropolishing) 9.6 Aluminium(electropolishing) 4.6 Table 4 Surface properties of various plastics and metals Adhesion energy (dyn/cm) 43.1 42.0 47.8~72.7 52.7~53.8 75.2 97.7 109.0 144.2 145.0 This characteristic is sometimes called "mold releasability". It can also be expressed as antifouling because it does not easy to adhere. Heat resistance Fluoropolymers have high heat resistance as follows. They have higher heat resistance compared to other general-use resins Fluoropolymers Heat resistance : maximum operating temperature (C) PTFE PFA FEP ETFE 260 260 205 150 Table 5 The heat resistance of Fluoropolymer 3 PCTFA PVdF 120 120 Other general-use resins PP PVC 100 60 Electric insulation When the dielectric constant is low, the insulation in electrical components can be made thinner, leading to downsizing and weight reduction of the equipment. In applications where downsizing and weight reduction are necessary, it is an essential feature 2 Japan Fluoropolymers Industry Association(2020), Fluoropolymer Handbook, 14th edition. Page 34 Translated from Japanese. 3 DAIKIN INDUSTRIES, LTD. (2009) DAIKIN Fluoropolymer Handbook, Page 4 6 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Dielectric constant PTFE PVC Dielectric constant 46 Fluoropolymer FEP PFA 2.1 Non-fluoropolymer PEEK TPI (Thermoplastic Polyimide) 3.2 4.5 2.83.2 ETFE 2.32.8 Polyolefin 2.34 Table 6 The dielectric constants of various resins Fluorine rubber FKM FEPM 34 2.53.5 Non-fluorine rubber Silicone EPDM rubber 3.210 2.53.5 Low friction, self lubrication Friction coefficient of fluorine resin is lower than that of other resins. It is because polarizability (Mobility of electrons in an electric field) of C-F bonding is low (0.68) and the intermolecular force is weak. (Reference: polarizability of C-Cl bonding is 2.59) 4 Types of plastic Plastic / Plastic Plastic / Steel Steel / Plastic PTFE 0.04 0.04 0.10 PE 0.10 0.15 0.20 PS 0.50 *) 0.30 0.35 PMMA 0.80 *) 0.50 *) 0.45 *) *) indicates occurrence of stick-slip motion. Measurement condition: Bowden-Laden type measurement equipment, load: 9.8-39.2N, sliding speed: 0.01cm/s Plastic/Steel indicates sample material/pin material PE: polyethylene PS: polystyrene PMMA: polymethylmethacrylate Table 7 Comparison of friction coefficient among PTFE and other materials5 As an example of low friction, Table8 shows friction coefficient of PTFE. Type Coefficient of static friction ASTM test method - Measurement condition Against polished steel Unit PFA PTEF FEP - 0.05 0.02 0.05 Table 8 Comparison of static friction coefficient among PFA, PTFE and FEP6 One of the characteristics related to friction is "self lubrication". The molecules of PTFE separate from molding of PTFE due to friction. The molecules in crystals of PTFE separate easily because 4 Japan Fluoropolymers Industry Association(2020), Fluoropolymer Handbook, 14th edition. Page 9 Translated from Japanese. 5 Japan Fluoropolymers Industry Association(2020), Fluoropolymer Handbook, 14th edition. Page 24 Translated from Japanese. 6 DAIKIN INDUSTRIES, LTD. (2009) DAIKIN Fluoropolymer Handbook, Page 53 7 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan intermolecular forces are weak. PTFE moves and attaches to the friction mating surface and generates friction between them. It lowers friction coefficient. 7 Gas barrier properties/Gas permeation properties Fluoropolymer film are less steam permeability. Figure 2 The degree of steam permeability 8 steam permeability (g/m2/d) 7 Japan Fluoropolymers Industry Association(2020), Fluoropolymer Handbook, 14th edition. Page 24 Translated from Japanese. 8 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 109 8 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Fluorine elastomers are less atmospheric (nitrogen, oxygen) permeability. Temperature Material degree He H2 O2 N2 CO2 Celsius Vinyl methyl 25 400 400 200 1600 silicone rubber N/A VMQ 50 570 500 280 1550 Ethylene propylene rubber EPDM 25 16.5 5.90 79.2 N/A N/A 50 46.6 13.7 183 Perfluoro- elastomer 25 10.3 8.25 2.5 8.1 28.7 FFKM Styrene butadiene 25 17.5 30.5 13 4.8 94 rubber SBR 50 42 74 34.5 14.5 195 Vinylidene fluoride fluororubber 25 2.95 4.6 1.0 0.8 3.9 binary FKM Vinylidene fluoride fluororubber 25 2.64 4.13 1.7 0.7 1.6 Ternary FKM Chloroprene Rubber CR 25 N/A 10.3 3.0 0.89 19.5 50 28.5 10.1 3.55 56.5 nitril-butadiene 25 9.32 12.1 2.94 0.81 23.5 rubber Mid-high NBR 50 23.4 33.7 10.5 3.58 67.9 nitril-butadiene 25 5.2 5.42 0.73 0.18 5.67 rubber High NBR 50 14.2 17.0 3.5 1.08 22.4 butyl rubber IIR 25 6.4 5.5 0.99 0.25 3.94 50 17.3 17.2 4.03 1.27 14.3 10,/,sec,atm Table 9 Comparison of gas permeability of elastomer9 CH N/A N/A 3.3 N/A 0.6 0.4 2.5 9.8 N/A N/A 0.6 3.2 C2H2 C3H8 10000 N/A or more 91.2 N/A 246 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 18.9 26.9 68.3 78.3 8.25 11.2 19.8 33.1 1.28 N/A 5.82 9 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 78 9 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Property of Gas Permeability Property N2 O2 Gas permeability H2 Gas coefficient CO2 Permeability CH4 C2H4 Water-vapor permeability Water Absorption Table 10 Gas Permeability of FEP film10 Standard Test method ASTM D1434 JIS Z0208 ASTM D570 Unit /s atm g/24h 24h Fluoropolymers permeate small molecular gases, such as oxygen and nitrogen, FEP film 12010-10 37010-10 1,08010-10 97010-10 6610-10 4410-10 1.6 <0.01 conversely, large molecular gases do not permeate. Fluoropolymer properties are used in permeate membranes for measurement and analysis. Gas FEP Gas Permeability PTFE N2 O2 CO2 CH4 CH3 CH C2H4 1.210-8 3.710-8 9.710-8 0.6610-8 0.6610-8 0.1110-8 0.4810-8 1.110-8 3.210-8 8.910-8 Temperature: 25 degree Celsius(77F) Units: cm3 (ST P) cm/cm2atm Table 11 Comparison of gas permeability of various materials11 Low Density Polyethylene 0.7410-8 2.210-8 9.610-8 2.210-8 5.210-8 7.210-8 Low refractive index Amorphous fluoropolymer resin has high transmittance. This is utilized for optical components and optical fibres. Figure 3 Comparison of transmittance Wavelength (nm) 1 10 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 78 11 DAIKIN INDUSTRIES, LTD. (2009) Daikin Fluoropolymers HandbookPage 80 10 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Weatherability Fluoropolymer resin has high weatherability and can be used outdoors. It does not react to sunlight such as ultraviolet rays. It is not susceptible to oxidizing effects of atmospheric oxygen and other substances (see "chemical resistance"). It can be used in a wide temperature range from low to high (see "heat resistance"). It has high water repellency and does not absorb water, so it is not affected by humidity changes. It can be said that fluoropolymer resin has high weather resistance because it has the above points. Table 12 Fluoropolymer resin weatherability comparison 12 Fluoropolymer resin General resin PTFE PFA FEP ETFE PCTFE PVdF PP PVC Weatherability Excellent, Good Not very good Needs attention Not good Regarding the graph below, it can be seen from the accelerated weatherability test with the Sunshine Weather Meter that the gloss retention rate decreases by no more than 10% even after 4000 hours of exposure. 13 Fluoropolymer resin paint Urethane paint Acrylic silicone paint Figure 4 AcceElexrpaotesudrewetimatehebryawbieliatythteersmt eotfepr(ahi)nt Gloss retention rate of paint film (%) 12 DAIKIN INDUSTRIES, LTD. (2009) DAIKIN Fluoropolymer Handbook,Page 4 13 https://www.kyoeishoji.co.jp/business/chemical/fusso_toryo.html translated from the document in Japanese. Last accessed on 21 July, 2023 11 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Tensile strength (MPa) Figure 5 Outdoor exposure test Comparison of tensile strength between ETFE and other materials 14 Durability It means that it can be used for a long time. Due to its high chemical resistance and high weatherability, PFAS can achieve high durability. Resistance to creep / Compression set When a constant load is applied to a polymeric material, creep occurs, in which deformation progresses over time. Similarly, compression set occurs where the deformation does not recover when the force is removed. Both properties are known to be correlated. When rubber materials are used in elastic applications such as packings or diaphragms, it is required to minimize the effects of both properties. Experimental examples of "30% creep time (Hour)" for major rubber materials are shown below. Creep is known to be worse at higher temperatures, Experiments have shown that FKM and silicon exhibit good properties. NR SBR CR NBR IIR FKM Silicon Table 13 50 degree Celsius 190 1250 4200 3900 70 degree Celsius 103 203 550 380 100 degree Celsius 3.8 14 45 41 2.7 1650 120 degree Celsius 7.4 12.2 305 1550 150 degree Celsius 180 190 Quoted from the journal of "the Society of Rubber Science and Technology, Japan", 1960(Vol33), P882-892, "Stress relaxation and creep properties of various vulcanized rubbers". 14 https://www.taiyokogyo.co.jp/feature/etfe_film.html translated from the document in Japanese. Last accessed on 21 July, 2023 12 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Examples of compression set test results are shown below. In general, it is difficult to quantitatively compare materials because the measured values differ depending on the compounding and hardness of the rubber. Here, the compression set of the materials was compared by comparing the minimum value of each material in the database. FKM and silicon showed relatively good properties, showing the same tendency as creep. NR SBR CR NBR IIR EPDM FKM Silicon Compression set JISK6301 100 degree Celsius70h Min 20 Min 23 Min 9 Min 23 Min 11 Min 6 Table 14 The minimum value of each material was quoted from the data described in "Material Database / Organic Materials" (1989), The Nikkan Kogyo Shimbun". 13 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Uses of PFAS in Specialist Equipment Summary PFAS are a very important group of substances for Specialist Equipment, which depends on these uses to maintain safety, as they are highly effective in chemical resistance, Repellency from water and oil, and electric insulation. PFAS polymer resins are two to ten times more expensive than other commodity plastics. There is no use other than where the equipment does not work without the use of PFAS. General electronics components are not covered in this document. However, since our equipment also uses common electronic circuit parts, we also use parts common to information equipment and general consumer EEE. For usage and non-substitutable information for such parts, please refer to Japan 4EE Opinion RCOM21, No.4543 and additional Opinion Information and Non-Substitutable Information to be submitted in September 2023. Semiconductors are also used in our products. Many PFASs are used in semiconductors and semiconductor manufacturing equipment. 14 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan electric wires and insulation An electric wire is a linear member for transmitting electricity. Metal, which is a good conductor, is used for the part that transmits electricity, and plastic resin that has electric insulation is used around the wire in order to block the influence on anything other than the transmission destination of electricity. Conductor Figure 6 Sheath Polyvinyl chloride is generally used for covering parts where plastic resin is used, which is called as sheath, but PTFE, PFA, FTPE, etc. are selected depending on the suitability of use and electric insulation requirements. Since these are more expensive than polyvinyl chloride, they are used only when it is difficult to use other materials such as polyvinyl chloride. PFAS functions required by PFAS wires and availability of alternatives. Wires using PFAS for coating have high electrical insulation when the coating is thin (100 m or less). PFAS also has a high heat resistance of 150-200C. In addition, PFAS wires can be used even when there are chemicals around the device because PFAS has chemical resistance. Examples of devices equipped with electric wire and insulation (KM) Board terminals of Luminance meter The luminance meter uses PFAS for the optical sensing substrate, which handles currents as extremely small as a few pA (10-12 A). Since the extremely small current output from the optical sensor is measured and used, even if a tiny amount of current leaks out from the original path onto the substrate, it is a critical error factor. Since leakage current values must be controlled to be sufficiently smaller than pA units, electronic components are wired floating off the substrate, as shown in the following figure9. However, since it is inevitable that the soldered part comes in contact with the substrate, a PTFE terminal with high insulation properties is used as a prop for connection (connection prop), and soldering is performed there to ensure high insulation to the substrate. Then, leakage current generation is controlled. Without PTFE terminal, the product doesn't satisfy its function. 15 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Figure 7 In circuits that handle very small currents at the several pA level, leakage current must be controlled as described above, and the connecting pillar must have very high insulation (about 1015) under all environmental conditions (temperature, humidity, etc.). (AB) Cable for Sapphire Capacitance Diaphragm Gauge The components use electric insulation with PFAS. Temperature sensor for control Heater board connection cable and thermistor 16 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan thermal insulation cap thermal insulation case ->Contains Fluororubber(FKM) Sensor <--> Board connection cable ->Sheath, insulator, etc. contain Perfluoroalkoxy alkane(PFA) Temperature sensor for control ->Heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane(PFA,PFE) Heater board connection cable and thermistor ->Thermistor heat shrink tubing, cable coating, etc. contain Perfluoroalkoxy alkane(PFA,TFE,PTFE) Figure 8 There is no fluorine-free material with equivalent heat resistance. (CN) Temperature sensor (thermocouple) A thermocouple is a temperature sensor that measures using the principle that a thermoelectromotive force is generated by connecting the tip of a metal wire made of different materials and the temperature difference between the tip and the other end. Temperature sensors can measure a wide range of objects, including acids, alkalis, and organic solvents, and can also measure a wide range of temperatures, including applications that measure chemicals at 100C or higher. The thermocouple wires are coated with FEP and PFA to ensure accurate measurement without negative effects from chemicals or high temperatures. There is no material other than fluoropolymers that combines chemical resistance and heat resistance to realize such applications, and it is difficult to replace them. 17 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Temperature measurement (connection) part Coating Wire Figure 9 Coated temperature sensor wire Heat shrink tubing By putting a thin and long object to be covered in a tube, heating it, and shrinking the tube, the object is covered. It prevents parts from coming off or falling off, and strengthens the covered part. Fluoropolymer resin heat-shrink tubing is thin but has high electric insulation performance. PTFE and PFA are used as fluoropolymer resins. Functions of PFAS required by heat-shrinkable tubing and availability of alternatives. Fluoropolymer resin heat-shrink tubing is thin but has high electric insulation performance. It can be used in applications where there is not enough space for electric insulation, and there is no alternative material available for applications that require tight spaces. Examples of the products which incorporate heat shrinking tubes (AB) Thermistor protection for Sapphire Capacitance Diaphragm Gauge Components corresponding to a heater operating temperature of MAX 250C For the picture of this products, please see the explanation in electric wires and insulation. Fluoropolymer resin is used in the heat-shrinkable tube to protect the thermistor. There is no fluorine-free material with equivalent heat resistance. Sealing materials Parts description Packings, gaskets, and O-rings Packings and gaskets exist to connect and seal by placing/placing them between parts. As an example, they are used in piping and pipe connections. Gases and liquids that pass through 18 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan pipes leak out through the smallest gaps, and packing gaskets exist to prevent this. Packing in the narrow sense is used for power system parts, and those used for non-moving parts are called gaskets. Various innovations have been made in molding and realizing functions, such as spiral gaskets made of alternating layers of thin metal strips and PTFE sheets, and wrapped gaskets made of 0.4~0.8 mm hot PTFE, covering gaskets of metal or other materials. Those with a circular/round cross section are called O-rings. In addition to PTFE, fluoropolymer rubbers such as FKM and FFKM are also used for this application. Figure 10 Packings, gaskets, O-rings Bearings A bearing reduces friction between two parts to make movement smoother. Bearings are classified into radial bearings, thrust bearings, and linear bearings, depending on whether rotational or linear motion is involved. A bush is also a type of bearing. Fluoropolymer bearings such as PTFE have a low coefficient of friction and can maintain a constant torque within various tolerances, while minimizing rattling and noise. In particular, PTFE must be used for bearings near chemical fluids such as acids, alkalis, organic solvents, and ozone, and for food contact applications, where oil is not preferred. Rotating shaft Brush Case Turbine Figure 11 Water or Air Bearing used for the rotating shaft sliding part of the sensor cleaning brush 19 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Sealing tape Sealing tape, made of PTFE material, is an adhesive tape used to secure parts within equipment. It is employed to fasten parts that could pose safety risks if dislodged, as well as to seal mounting parts. Additionally, the tape serves as a filler to address gaps in the joints or connections of pipes for flowing liquids or gases, such as water pipes, air pipes, and hydraulic pipes. Notably, the tape can establish liquid- or gas-tight connections with tapered pipe threads by directly filling the voids between the threads. Figure 12 The functions of sealing materials of PFAS and alternatives Functions of PFAS Required by Sealing Materials and the Feasibility of Alternatives to PFAS Required Functions for Sealing Materials Liquids and gases flowing in pipes, or near parts, often consist of strong acids, alkalis, or organic solvents. Therefore, the sealing materials used must be resistant to these chemicals. Fluoropolymer is highly resistant to such chemicals, and additionally, it is ozone-resistant, making it an ideal choice when ozone is present in the piping. If the liquid or gas in the piping, or the equipment itself, operates at high temperatures, PTFE or PFA are good options due to their high heat resistance of up to 260C, a limit higher than other resins. FFKM and FKM rubbers also exhibit high heat resistance, withstanding temperatures up to 250-300C. For applications where sealing materials, such as gaskets, are used on sliding surfaces, where lubricating oil is unsuitable (particularly in contact with food), or where play and noise must be avoided, sealing materials must also possess low friction and self lubrication properties. In the restriction report on seal tape, paste-like sealing materials are mentioned as alternative materials. However, if these sealing materials contain hydrocarbon substances, reactive functional groups may decompose. This could pose a risk of contamination in the surrounding area due to the produced decomposition products. For sealing tape used for equipment operating in clean environments, where such contamination is unacceptable, paste-like sealing materials cannot be used as alternatives. 20 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan As a sealing material that combines outstanding chemical resistance, ozone resistance, heat resistance, water and oil repellency, low friction, self-lubrication, and cleanliness, there is no substitute for fluoropolymers. The substitution of fluoropolymers with other materials poses a significant challenge. Non fluorine elastomers might be considered as potential replacements for fluorine rubbers like FKM rubber. However, their heat resistance, low friction, and chemical resistance do not measure up to those of fluorinerubbers like FKM rubber. Therefore, substituting fluorine -rubbers with non fluorine elastomers is unfeasible. Examples of the products which uses sealing materials YDPressure Transmitter: Pressure transmitters are measuring instruments mainly used in factories and plants. It measures pressure for process fluids such as liquids, gases and steam and outputs analog or digital signals corresponding to the measurement results. It is also used to measure flow rate and liquid level based on measured pressure. The process fluid to be measured has various characteristics such as temperature, pressure, and properties. If the sealing performance is not maintained, not only correct measurement results not be obtained, but the factory or plant may stop. In addition, if the process fluid is high temperature, extremely low temperature, or toxic or corrosive, the outflow of the fluid may cause great damage to the surrounding environment and workers, so the sealing performance is very important. Many sealing materials that use PFAS materials have excellent heat resistance and chemical resistance, and it is considered difficult to replace them when considering the above safety assurance. O-R - It is used for sealing the mating part of the product. Figure 13 Wetted O-RING Gasket Seal a product and pipe fittings. Fluid leak prevention. 21 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan GASKET Collar Gasket usage example Figure 14 (AB) Junction unit for vacuum environment / O-ring for seal for air and vacuum environment Optical Junction unit for vacuum environment is used for a photoelectric sensor that enables detection inside a vacuum chamber by transmitting light from a fiber amplifier through a fiber unit. The optical coupler is provided with sealing ability to pass the detection light through the wall of the vacuum device. The O-ring for sealing are made of fluorine rubber to keep high temperature, high seal and high cleanliness 22 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan VACUUM CHAMBER Enlarged view VACUUM CHAMBER Junction unit Figure 15 To keep high temperature, high seal, and high cleanliness in a vacuum environment, materials other than fluorocarbon rubber are not appropriate. O-rings are used as sealing parts to prevent external leakage at joints between different parts. (AB) Mass Flow Controller / Mass Flow Meter O-rings are used as sealing parts to prevent external leakage at joints between different parts. <Mass flow controller usage example> cross section Example of use in joints between fitting parts and mass flow controllers Example of use for joints between flange parts and body parts Figure 16 FKM is used for various gases with excellent heat resistance, chemical resistance, ozone 23 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan resistance, etc., especially when using flammable oxygen gas, it is used due to its high heat resistance and ozone resistance, and the alternative product is a special rubber material, but it becomes a fluorine-based rubber material and the use of fluorine-based substances is unavoidable. If fluorine-based materials are not used, safety is significantly impaired. Plumbing Plumbing is any system that convey fluids or energy for any application. Pipes, tubes, joints, fittings, are used for plumbing. Fluoropolymer resins, such as, PTFE, PFA, PVDF, are used. Some international standards mention uses of fluoropolymer resins for plumbing. 15 Tubes (not heat shrink tubes) Tubes are used for convey fluids to the places. Figure 17 Joints / fittings Joints / fittings are components to connect tubes to units and/or tubes to tubes. Figure 18 The functions and alternatives which plumbing requires: The material of plumbing is determined by the types of fluids flowing through tubes. Fluoropolymers can be used as piping for fluids in the temperature range of -10C to 200C (PTFE) and about -40C to 160C (PFA), including acids, alkalis, organic solvents, ozone, and oils. Fluoropolymers (PTFE, PFA, PVDF) are the only plumbing materials that can be used when 15 Example of international standards: ISO 12039:2019 mentions that the sampling line shall be made of PTFE, PFA. 24 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan the fluids of flowing the tubes meets one or more of these characteristics. Fluoropolymer resins are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of chemical resistance/ cleanliness, repellency from water and oil, and heat resistance. Examples of the products which incorporate plumbing (YD) Magnetic Flowmeter An Electromagnetic Flowmeter is a type of flow meter that applies a magnetic field in the perpendicular direction to the flow of the measured fluid. As a result of the flow and the magnetic field, an electromotive force is generated in directions perpendicular to both the flow and the magnetic field. This electromotive force is extracted by a pair of electrodes, and the output signal is sent to a converter. The electromagnetic flow meter is a flow meter that applies Faraday's law of electromagnetic induction to moving objects. Electromotive force (E) Excitation current Excitating coil Lining Velocity: V Measurement fluid Pipe Electromotive force: E Electrode Pipe inner diameter: D Magnetic field (Magnetic flux density: B) Figure 19 The resin lining, known as lining, is applied to pipes (metal piping), and materials such as PFA and PTFE are used. The purposes of this lining are as follows: Electrical insulation: The lining ensures electrical insulation between the measured fluid and the electrodes or the pipe, preventing electrical short-circuiting of the signal electromotive force. Chemical resistance: The lining provides resistance to chemical substances such as acids and alkalis when the measured fluid contains them. This prevents corrosion and degradation caused by the fluid's characteristics and the environment, thereby improving the accuracy and reliability of the measurement. Wear protection: The lining plays a role in protecting the pipe from internal friction and impacts. It reduces wear and damage caused by solid particles and abrasives in the fluid, maintaining measurement performance over an extended period of use. Heat resistance: The lining exhibits stable performance even in high-temperature environments. 25 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan It resists degradation when exposed to high-temperature fluids and environments, ensuring consistency and reliability in the measurements. (SS) Differential scanning calorimeter Tubes to flow the liquid nitrogen below -196 degrees C. Flexible pipes made of metals other than resin cannot be used because of possible cracking due to cold embrittlement. In addition, because metals have high thermal conductivity, there is a greater risk of low-temperature burns during unintended contact and frost due to their high thermal conductivity. Less flexible. Tubes with an inner diameter of 16 mm are commercially unavailable. (AB) Micro flow rate liquid flow meter Fluororesin fitting Figure 20 PFA,FTFE Characteristics of PFA,PTFE Inert to many chemicals Resistance to aging Less additives Soft Easy to process Benefits of using PFA,PTFE Semiconductor manufacturing process is required high level chemical controls, due to chemical contamination makes negative influences on quality of products. PTFE and PFA which are inert to various chemicals and also include low additives, are suitable materials for flow paths in semiconductor manufacturing process. Impact of prohibition using PFA,PTFE 26 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan It will be impossible to keep miniaturization technology used in current semiconductor manufacturing process. To avoid this problem would require a great deal of effort and technical innovation. Valves Valves are general for equipment with a movable mechanism that can open and close flow paths in order to go through, stop, and control the flow of fluids. They are used in a wide variety of products, from relatively small devices with flow paths and valves to large-scale manufacturing processes and chemical plants. There are many types of valves. Some valves, which are often incorporated in specialist equipment, are discussed. They are not exhaustive. The functions and alternatives which valves require: The chemical resistance against acids, alkalis, organic solvents oils, and ozone, which flows through valves, is essentially required. Valves, which opens and close frequently required the property of low friction, repellency from water and oils, non-adhesion. Any failure of valves can cause serious accidents. therefore, the durability of fluoropolymer resin is required for valves PTFE and other fluoropolymer resins are frequently used. Fluoropolymer resins, such as, PTFE are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of valves. - Solenoid valve A solenoid valve is electromehanically operated. One of the operations is to open and close a valve using the principle that when an electric current is applied to an electromagnet (solenoid), an iron piece called a plunger is attracted and released when the electric current is cut off. Diaphragms divide into a valve compartment that opens and closes flow paths and a functioning compartment that drives. Fluoropolymer resins, such as, PTFE, FKM, FFKM, and FEPM, are frequently used for flow paths, diaphragms, and sealing materials in solenoid valves. Solenoid valves have wide variety of types, such as, liner action, pilot operated, the combination of liner action and pilot operated. - Ball valves A ball valve opens and closes a flow path by rotating a hollow ball. In automatic valves, an electric motor is used to rotate the ball. A large cross-sectional area of the flow path can be obtained, and the resistance of the path can be kept low. Fluoropolymer resins, such as, PTFE, are frequently used 27 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Stem Ball Figure 21 Sheet - Check valve A check valve is installed on gas or liquid piping where the fluid back pressure closes the valve plug to prevent reverse flow. A check valve is called as non-return valve, reflux valve, retention valve, foot valve, or one-way valve There are disc check valves that blocks backflow by closing the O-ring valve with a disc and duckbill check valves that uses a valve plug shaped like a duck's beak. Fluorinated materials such as PTFE, FKM, FFKM and FEPM are used for the valve plug and the sealing materials of the housing. Figure 22 - Relief valves/safety valves A relief valve is a valve that automatically releases pressure when excessive pressure occurs in the pipes. A spring keeps the valve plug such as O-rings or diaphragms closed, and it opens (released) when a pressure exceeding the spring force occurs. Fluorinated materials such as PTFE, FKM, FFKM and FEPM are used for the valve plug and the sealing materials of the housing. 28 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Primary side Spring Pressure adjustment bolt Diaphragm Flow direction (atmospheric release) Figure 23 Examples of the products which incorporates valves (NA)Mass Flow Controller Elemental analysis is a method of complete combustion of organic compound samples, and high-purity oxygen gas and argon gas are introduced. (see below) Figure 24 The switching valve of the mass flow controller is a diaphragm type, and PTFE is used to provide flexibility to withstand repeated operation and durability against oxygen gases. PTFE is difficult to find replacement. Because it is highly non-adhesion and the substance does not stick to it like other fluoropolymers, and it has overwhelmingly low friction and excellent durability compared to other resins. 29 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan (AB) Control valve of mass Flow Controller Mass flow controllers are used for flow control of various industrial gases. PTFE is used as the material of the valve body of the flow control valve of mass flow controller. See part (10) in the figure39 below (the right is a partial enlarged view). Performance requirements for materials. Heat resistant to withstand operation from -10C to +60C. Chemical resistance to withstand components contained in combustible gases. Resistant to ozone gas. Cross-sectional view of the product Cross-sectional view of the valve Figure 25 Enlarged vie 30 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan HBMass flow controller for semiconductor manufacturing Mass flow controller for semiconductor manufacturing PFA coating is applied to the valve that functions to accurately supply the amount of etching gas in the etching equipment for semiconductor manufacturing. When the valve is closed, it must be tightly closed and impermeable to gas. Low friction is necessary because it must not wear out even with the impact of continuous opening and closing of the valve. The friction ecoefficiency of silicone is low, and silicone cannot be used for this application. (TD) Fluoride ion measuring equipment This equipment is mainly used to measure the concentration of fluoride ions in factory wastewater. Fluoride ions are detected by an ion electrode, and the concentration can be monitored continuously by sending the sample to the flow cell holding the ion electrode with a liquid sending pump. The sample water is an aqueous solution such as factory wastewater. Various ionic components and insoluble solids are included depending on the type of production. Used as a switching valve for the solution feed channel The valve is used as a switching valve for the solution feeding flow path, and the body and diaphragm valve are PTFE solenoid valves. (AB) Control valves Control valves are used in a variety of different markets that controls fluid flows in plumbing installed in air conditioning system of building, and Industrial plants, for example petrochemical and power plant. Examples of control valve products PTFE seat ring is a component of control valves that has a function of stopping the flow by contacting with the plug when it is fully closed. In general, the friction coefficient of PTFE (0.1 or less) is approximately 1/5 that of metal (approximately 0.5), and the torque required to rotate the plug is approximately 1/5 in proportion to the friction coefficient. Add that, corrosive and high temperature fluid flows through control valves. So, excellent chemical and heat resistance are required to control valves. PTFE fills all of characteristics aforementioned. Furthermore, it has proven track record of long-term use in various fields. 31 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Control Valve for industrial plant rotary motion Plug up and down motion Valve Seat Seat Ring Control Valve for HVAC ball Figure 26 ABMaterial for scraper rings in industrial control valves Scraper Ring Valve Seat Stem Bonnet Gasket Upper Cage Plug Lower Cage Seat Gasket Figure 27 The PTFE scraper ring scrapes off the fluid adhering to the cage of the control valve and prevents sticking of the plug and cage. Industrial control valves are used to control corrosive fluids such as chemicals, and are required to have performance that can withstand the control of corrosive fluids. On the other hand, in identifying corrosive fluids, there are many fluids that are difficult to determine physical properties such as intermediates of chemical substances, and materials that have a wide range of chemical resistance are required. 32 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan In order to control corrosive fluids with industrial control valves, scraper rings made of PTFE are required in the flow passages where corrosive fluids come into contact. Other polymer materials, such as rubber and resin, might be able to substitute for PTFE as the material of scraper rings. However, it is considered that the alternative materials are not suitable, because they do not have enough resistance to various chemicals of chemical plants. (AB) Lining and throttling mechanism materials for industrial control valves. Aperture mechanism Figure 28 valve linings Industrial control valves are installed in pipes of various industrial plants, that are used to control flow of fluids. Industrial control valves are used to control corrosive fluids such as chemicals. Industrial control valves are required to be able to withstand the control of corrosive fluids at high temperatures (approximately 140C). In order to control corrosive fluids with industrial control valves, main body linings and throttle mechanisms made of PFA, ETFE and PTFE are required in the flow passages where corrosive fluids come into contact. Depending on the fluid used, PFA and ETFE are used in the body lining, and PTFE is used in the throttle mechanism. It is possible that other polymer materials such as rubber and resin can be used as alternative materials for body lining and throttle mechanism using PFA, ETFE, and PTFE. However, alternative materials have poor resistance to a wide variety of chemicals in industrial chemical plants and cannot withstand corrosive fluids. If it is assumed that metal materials such as chromium and nickel alloys will be substituted, it is necessary to periodically stop the equipment and check the corrosion status of the control valves connected to the pipes. When corrosion occurs, fluid control becomes impossible, so it is necessary to replace the industrial control valve itself. 33 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Pumps Discharge Process Suction Process Valve Diaphragm Valve Figure 29 Explanation on Pumps 16 A pump is a device that transfers, pumps, and stirs liquids and gases under the action of pressure. It is divided into two types according to the difference in structure: non-positive displacement pumps and positive displacement pumps. Non-positive displacement pumps are pumps that impart energy to liquids by rotating impellers, and include centrifugal pumps, propeller pumps, and viscous pumps. A positive displacement pump is a pump that pressurizes and energizes a liquid that is within a certain volume, and there are plunger pumps, diaphragm pumps, gear pumps, etc. In pumps, fluorine rubber such as FKM, FFKM, and FEPM is used for the sealing members and diaphragms of the housing. PTFE is used for the impeller bearings. PFAS functions which pumps require and alternatives Pumps used to transfer fluids such as acids, alkalis, organic solvents, oils, and ozone require high chemical resistance for each member in contact with the fluid. Especially in the case of diaphragms, durability that can withstand repeated bending are also required. Fluorine materials such as FKM, FFKM, and FEPM are used as materials to satisfy these requirements, and it is difficult to replace them with other materials. In the case of bearings, low friction, self-lubrication, and wear resistance are also required. Fluorine materials such as PTFE are used as materials to satisfy these requirements, and it is difficult to replace them with other materials. Coating/Lining Part Description A surface treatment in which the surface or inner surface of a base material is covered with a fluoropolymer is called a coating or lining. A relatively thick covering is often referred to as a lining, while a thin covering is often referred to as a coating. There are various methods such as molding, bonding a sheet to the base material, bonding powder, or covering with a liquid. Fluoropolymers used include PTFE, PFA, PCTFE, FEP, and ETFE. 16 https://www.monotaro.com/note/cocomite/525/ 34 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Metal plating and surface treatment containing fluoropolymer resins are used to adhere to metals. Coatings and linings are applied to parts in contact with fluids. The parts include the inner surface of the piping and parts in contact with the fluid. Coatings may be applied to areas where water repellency to water and oil, low friction, self lubrication, and non-adhesion are desired. Examples of coating / lining Piping inner surface Pipe Connection flange Lining Figure 30 Coating and lining section of parts (diaphragm) in contact with fluid Figure 31 PFAS functionality required by coating/lining and possible substitutions By covering the surface with a fluoropolymer, PFAS gains chemical resistance/cleanliness and mold-releasing properties that the base material does not have. Coatings and linings in contact with fluids can withstand corrosion and operate stably without maintenance for long periods of time (10 years). For example, fluorine coatings and linings on low-hardness rubber materials provide both high flexibility and chemical resistance. When the fluid is a powder, it is difficult for the fluid to adhere to the coating/lining area due to non-adhesion of fluoropolymers. 35 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Examples of Parts and Equipment Using Lining and Coating There are a great many devices that coat base materials that come in contact with fluids. AB Lining for fluid contact parts of electromagnetic flowmeters and pressure transmitters Equipment around piping such as electromagnetic flowmeters and pressure transmitters cannot maintain their performance without fluoropolymer resin linings and coatings in order to withstand various fluids such as acids and alkalis. Linings using ETFE or PFA can operate stably for 10 years without maintenance. Accidents may occur if the equipment continues to operate with the fluid flowing through the piping without noticing that it has been corroded by the fluid. In order to maintain the work environment and safety management, it is necessary to use fluoropolymers that can be safely used for a long period of time without replacement for devices that pass corrosive fluids. (AB)Environment-resistant photoelectric switch with built-in amplifier. The Housing coated with black fluorocarbon resin. Fittings for fixing built-in parts Figure 32 External View/ Detection of workpiece seating in machine tool Improved corrosion resistance of housing The housing of Environment-resistant photoelectric switch is made of zinc die-cast. Zinc diecasting has advantages such as high fluidity, easy dimensional accuracy, low molding temperature, and long service life of metal mold, but it has low chemical resistance. Therefore, it cannot be used in machine tools and automobile parts machining lines, which are users of this switch, unless corrosion resistance is improved by painting and plating. Watersoluble coolant (basic) is often used in machine tools and automobile parts machining lines, and zinc die-cast housing is highly likely to be corroded unless surface treatment such as painting is performed (Figure 32). 36 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Switch Figure 33 Confirmation of Existence of Tool in Machine Tool Prevention of crevice corrosion and dissimilar metal contact corrosion The H2B housing is assembled with a metal stopper (SUS plate (zinc plated)) (Figure 32) and attached to an accessory SUS bracket or the mounting surface of the user side (metal, resin, etc., materials cannot be specified) (Figure 33). Therefore, it is necessary that the metal surface of the housing is not exposed in order to prevent electrolytic corrosion due to gap corrosion and contact between different metals. The former model number of this switch had adopted acrylic coating, but it was changed to fluorine coating due to low resistance to water-soluble coolant. The surface of the housing must be free from exposed metal. Therefore, coating by coating is necessary instead of plating. For the same reason, coating is necessary even if the housing is changed to a highly chemical resistant metal material such as SUS. There are concerns about the following impacts due to the unavailability of this technology Affects machining with machine tools that use water-soluble coolant and parts machining and production on automotive parts production lines There is no alternative technology. When a switch without fluorine coating is used, corrosion of the switch causes contamination of corrosion products (foreign matter) into parts, generation of rust in processed parts, and increase of stoppage period of machine tools and production lines due to increase of sensor replacement frequency. 37 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan For the above-mentioned reasons, the prohibition of coatings with fluorine-based paints should be exempted indefinitely from this restriction because of the economic burden due to the increased frequency of replacement and the serious degradation to the finished product. In terms of disposal, restrictions should not be applied as coatings by fluorinated paints generally lead to a reduction in waste. (AB) Spatter-guarded proximity switch Part of the housing of the spatter-guarded proximity switch used in a welding environment. CapFluoropolymer resin PFA sensing surface HousingCoated with fluoropolymer resin. Housing Spatter-guarded proximity Cap Figure 34 The following features can be obtained by using Fluoropolymer resin. CapIt can withstand the heat of welding spatter. It is difficult for spatter to stick. HousingIt is difficult for spatter to stick. (RK)- Flame arrestor (sintered metal) surface Figure 35 Sintered metal flame arrestor is used to prevent the internal gas sensor element from becoming an ignition source. Surrounding gas reaches the sensor element through fine gaps in the sintered metal, but when water is adsorbed on the sintered metal, the flow path of the gas narrows. Therefore, in order to prevent water adsorption and corrosion on sintered metal, a fluorine coating is applied for the purpose of adding repellency from water and chemical resistance. - Inside the metal nipple 38 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Figure 36 Fluorine coating is applied to the inside of the metal nipple which is part of the gas flow path for the purpose of adding non adhesion in order to prevent the gas concentration from decreasing due to the adsorption of highly adsorptive gases. Repellency from water The flame arrester (sintered metal) is given water repellency by applying a fluorine coating to prevent clogging due to water adsorption and corrosion. Non-adhesion Fluorine coating is applied to parts of metal pipes that cannot be used due to insufficient strength of fluoropolymer resin pipes, such as when it is necessary to cut threads to fix them. Chemical resistance Fluorine coating is applied to the parts used in the gas flow path to provide chemical resistance. Fluorine coating can be used in acids, alkalis, organic solvents, ozone, and oils. (CN)Temperature sensor Contact type temperature sensors can measure temperature by contacting the object to be measured and reaching to the same temperature. The sensor measures the temperature using the element itself or an element inserted into a protective tube for strength. Temperature sensors can measure a wide range of objects, including acids, alkalis, and organic solvents, and can also measure a wide range of temperatures, including applications that measure chemicals at 100C or higher. Therefore, sensor elements, wires themselves, and protective tubes are coated with FEP or PFA to eliminate the adverse effects of chemicals and high temperatures and realize accurate measurement. There is no material other than fluoropolymers that combines chemical resistance and heat resistance to realize such applications, and it is difficult to replace them. Protective tube Coating Element Coating Wire Element(internal) Figure 37 Fluorine-coated temperature sensor 39 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Membrane filters Membrane filters are to remove and separate specific substances or objects from fluids. A wide variety of materials are used. If fluorine compounds are necessary, PTFE, FEP, ETPE and PFA are frequently used. Membrane Dissolved oxygen electrode Electrolyte Electrochemical gas sensor Measurement method of pH meter and diagram of membrane filter Figure 38 1. Gas components in the sample are go into the electrode through the membrane. 2. The pH of the internal solution changes according to the amount of the gas taken in, and the change of pH is read by a glass pH electrode. 3. The pH change of the internal solution is converted to gas concentration in the sample. The following properties are required for the membrane used in this application. There is currently no other material that possesses these properties at a level that can be used in products. Gas permeability Membrane must have sufficient gas permeability even under conditions of no pressure. Chemical resistance Membrane must have sufficient chemical resistance that will not deteriorate after immersion in various samples. 40 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Repellency from water Repellency from water is required in order not to permeable water. PVC, glass and PEEK are too high much gas barrier property to separate gases. PE is weak for acids. Glass is melt down by hydrogen fluoride and some gases. Fluorine compounds such as PFAS are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of membrane filters. PTFE filter used in the ozone decomposition catalyst unit of NOx measuring equipment A NOx meter needs to generate ozone to measure NOx by the chemiluminescence method. For accurate measurements, ozone is generated in excess of NOx in the sample. An ozone decomposition catalyst is used to decompose ozone remaining after NOx measurement, and a PTFE filter is used to remove the catalyst powder. TD PTFE filter is a filter with little adsorption and decomposition. Use is recommended in the Environmental Air Constant Monitoring Practices Promotion Manual. It also has better ozoneresistance than PVC and PE and is less priced than PEEK. PTFE porous membrane Electrochemical gas sensor Figure 39 41 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan 1Electrochemical gas sensor is constituted by a working electrode formed on a PTFE porous membrane, a reference electrode, a counter electrode, electrolyte and a housing which is holding other components. 2Every electrode is connected to a potentiostat circuit and the working electrode is implied fixed potential to that of the reference electrode. 3The PTFE porous membrane is in contact with atmosphere which may contain intended gas to be detected. 4The gas to be detected goes through by diffusion in the membrane and reaches the interface of the working electrode and the electrolyte. 5The gas is electrochemically oxidized or reduced. 6The oxidized or reduced reaction involves transfer of electrons between chemical species and the working electrode, hence current flows in the circuit. 7The current is measured to determine the concentration of the gas to be detected The following properties are required for the membrane used in this application. There is currently no other material that possesses these properties at a level that can be used in products. Gas permeability The membrane must have gas permeability at atmospheric pressure. Water resistance The membrane must have sufficient water resistance not to leak electrolyte. Corrosion resistance The membrane must have corrosion resistance. Examples of corrosive gases are NOx, SOx, halogen and halogen halide. Chemical resistance Heat resistance The membrane must have sufficient heat resistance over 150 degree Celsius to coat electrocatalyst. Non-adsorptive The membrane must have sufficient non-adsoptive. If the gas to be detected is adsoabed on the membrane, the gas can't go through the membrane, or it takes time to go through the membrane. 42 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Galvanic oxygen sensor Figure 40 1. Oxygen gas in the sample reaches through the membrane into the sensor. 2. The oxygen gas taken in is reductively decomposed at the cathode. A current flows according to the oxygen amount taken in. 3. The current is read as a voltage through a resistor such as a thermistor. The following properties are required for the diaphragm used in this application. Gas permeability The gas to be measured is taken into the electrode. This measurement is not possible without sufficient oxygen permeability even under conditions of no pressure. Among fluorine compounds, FEP has superior oxygen permeability compared to other polymer membranes. Chemical Resistance FEP is used in environments where it is in constant contact with various gases (acids, alkalis, organic solvents, etc.). The membrane filter does not deteriorate in these environments, does not elute components of the membrane filter when in contact with any sample, and must be resistant to chemicals. Water repellency and water resistance The membrane filter must be hydrophobic and water resistant to prevent water from permeating into the electrode. The material must not change after 10 years of exposure test as a material. 43 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Electrode -Parts in contact with liquid other than electrodes in electrode structure (of instrument that measures the physical quantity of a liquid by electrical means)An electrode in a measuring instrument is a part that is electrically connected to an object to be measured for the purpose of measuring the electrical signal of the measurement object. The instrument that measures the physical quantity of a liquid by electrical means has electrodes. In that type of instrument, the purpose of the electrodes is to acquire the electrical potential or charge at a certain area in the liquid. Therefore, In the electrode and surrounding structure, parts in contact with liquid other than electrodes must be non-conducting. As the non-conducting material, high hardness materials such as glass and ceramics can be used only very limitedly. because these high-hardness materials are inferior in workability and impact resistance. Therefore, in many cases, resin is used for parts in contact with liquid other than electrodes. And there is no resin material other than PFAS that can withstand the temperature and corrosiveness of liquids. Optical coating A water-repellent coating layer which contains Perfluoroalkyl or perfluoropolyether compounds is formed with a thickness of less than tens of nm on the outermost surface of coating layers of the ophthalmic lens surfaces. The water repellent coating provides superior properties such as water repellency, oil repellency, lubricity, smoothness and chemical resistance to the ophthalmic lens. These properties improve prevention of water discoloration on anti-reflection coatings, scratch resistance, ease of wiping off stains (fingerprints, sebum, etc.) on the lens surface and maintainability. As the results, these high performances enable to extend substantially the product life of lenses. And the water-repellent coating layer is coated on anti-reflection coating layers to eliminate the ghost and flare phenomena in lens optical systems. The one of valuable features is having both properties of low refractive index (n<=1.40) and high transparency of the coating layer which composed of perfluoroalkyl or perfluoropolyether compounds. *1 Ghosting/flare: Reflected light generated on the lens surface is repeatedly reflected in complex ways, resulting in the appearance of light images that are not actually there. The higher the reflectivity of the lens surface, the more likely it is to appear. 44 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan *2 Anti-reflection coating: A film with a function to reduce reflected light. In ophthalmic lenses, reflection is reduced by alternately layering materials with different refractive indices to utilize light interference. *3 Low refractive index: Since the lower the refractive index of the film of the top surface layer of an antireflection coating, the greater the effect of reducing reflections from the lens surface, a film material with a lower refractive index is required. The refractive index of general glass is 1.52, and the refractive index of base materials for eyeglass lenses is 1.50~1.90 (including plastic and glass). Figure 41 Functions of PFAS that required for lens coating and their alternatives. Ophthalmic lenses Ophthalmic lenses are daily exposed to sunlight, rain, sweat, and washed with detergents. So, high level repellency from water and oil are required for the coating of ophthalmic lenses. PFASbased coatings are widely used because of their excellent weatherability, low friction, and repellency from water and oil. The water-repellent coatings have been developed since the 1980s, but it is still very difficult to achieve the target performances with non-fluorine compounds. Even after more than 30 years effort, no coating without PFAS, which can pass abrasion resistance, chemical resistance, and weather resistance tests assuming everyday use, has been developed yet. As the proposal alternatives, silicone-based water repellents are representative material, though they can achieve fluorine-based equivalents in terms of contact angle to water, they have not been able to achieve fluorine-based equivalents in terms of contact angle to oil, chemical resistance, and low refractive index. 45 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Test results Performance comparison of fluorine-based perfluorinated polyether water-repellent coating and silicone-based polydimethylsiloxane water-repellent coating Contact angle Scratch resistance Chemical resistance Table 15 To water H2O To oil (Oleic acid C18H34O2 Steel wool load 500g 50 round-trip After 6hr dipping in alkaliNaOH aq. pH:11 After 6hr dipping in acidHNO3 aq. pH:1 Perfluorinated polyether 108 80 Good Good Good Polydimethylsiloxane 104 52 Bad Bad Bad Details Pictures of appearance after scratch test perfluorinated polyether polydimethylsiloxane Contact angle change in chemical resistance test Alkali Water Oleic acid Perfluorinated Before 108 80 polyether After 105 70 Before 105 52 Polydimethylsiloxane After 42 40 Table 16 46 / 68 Acid Water Oleic acid 108 80 104 70 105 52 48 31 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Water repellent effect by coating Without coating With Coating Figure 42 Difference among lens with coating and without coating 17 Period required for replacement: About 1.5 to 2 years, if a non-fluorine material with PFAS- equivalent performance is produced. Volume of PFAS to be placed on the EU market : car camera 0.32g/year Amount of PFAS entering in the EU as water-repellent coating materials on ophthalmic lenses The amount of PFAS entering the EU as water-repellent coatings on ophthalmic lenses is estimated to be 300 kg/year*1. The amount of PFAS entering the EU through water coating*2 is much smaller (1 ppm to 2 ppm) than the total amount of PFAS entering the EU through all applications (140,000 to 310,000 ton/year). 17 Cannon optron https://optron.canon/ja/evaporation/pickup01.html accessed on 31 May 2023. 47 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan (AB) Fiber unit for Measurement use Fluorine resin Figure 43 With FEP and PFA Structure This is a step index type multimode fiber (using the refractive index difference between core and clad). Fluorine resin is used for the clad. No alternative material has been proposed by the manufacturer at present. In this type of fiber, the basic optical characteristics of the fiber are determined by the refractive index difference between core material and clad material, and the material is selected by the manufacturer in consideration of the manufacturing method. Users use commercially available fiber. FEP is used for the clad and jacket, and PFA is used for the jacket and outer coating. Liquid level detection Detection method and part of use PFA PFA Purpose and materials used The tip detection part is made of PFA, and the tube material which may come into contact with liquid is also covered with PFA, a material which is easily fused with the tip. Principle using PFA characteristics Use refractive index difference between PFA and liquid In order to make the tip small and non-electric, a commercially available plastic optical fiber cable is used for guiding the detection light, and fluorine resin (specific material is not disclosed by the manufacturer) is also used as the clad material. It uses the difference in refractive index between liquid and liquid. Detection principle It utilizes the return light difference due to the refractive index difference (hereinafter referred to as n) between the material of the tip cone and the external contact material. Without liquid : In a state of lower refractive index than PFA (n 1.35) (air n 1), most 48 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan of the light emitted from the projection is reflected by the inner surface of the cone and returns to the light receiving portion to enter. Liquid : The liquid has a large refractive index equal to or higher than that of PFA (water n 1.33, ethyl alcohol n 1.36), and the amount of light that is substantially transmitted through the conical surface and returns to the light receiving portion decreases. The presence or absence of liquid is determined by this light amount difference. Leak detection PFA The detection head and cable, which may come into contact with liquid, PFA coverare covered with PFA. Use refractive index difference between PFA and liquid Chemical resistance Transparent examPFpAle PFA The detection head and cable, which may come into contact with liquid, are covered with PFA. Detection principle is the same as "liquid level detection" Sealing performance is ensured by fusing the tip of the PFA detection head and the tube. PFA Figure 44 49 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Due to the housing made of PFA resin, this fiber unit has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the fiber unit. - This fiber unit functions stably for the detection of organic solvents. - There is no alternative to this function This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. For the above reasons, the prohibition of PFA resin in leakage sensors affects safety and should be exempted from this restriction indefinitely. Heat medium Refrigerators, compressors, centrifuges Refrigerators are used for the units require temperature control, and pretreatment for measurement and analysis. Fluorinated gases are the only materials that can simultaneously provide and express multiple functions required for the proper functioning of refrigerators, such as, thermodynamic efficiency, surface tension, electrical insulation, inactivity, heat conductivity, and a wide range of operating temperature. HFCs as F-gas will be restricted by the EU F-gas regulation and international treaties. HFCs will be replaced by organic fluorine compounds that their GWP are smaller than carbon dioxide. In that case, the substituted organic fluorine compounds (GWP>1) will be further substituted. A succession of substitutions in a short period shortens the lifetime of specialist equipment, which is originally long-life. Refrigerators, compressors, centrifuges are used as units of specialist equipment, the derogation as spare parts should be considered. Specialist equipment cannot be repaired, it will be discarded and its lifetime will be shortened. Refrigerants must not leak from the unit, the units that uses refrigerants such as refrigerators, compressors, and centrifuges requires the sealing materials mentioned in this document. 5(f), (g), and (h) of proposal wordings are written in Annex A of the restriction report. Specialist equipment with a long Lifetime cannot be sufficient grace periods. The grace periods should be examined. 50 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Lubricating oil Lubricating oil is used to control friction and wear of metal contacting parts when machines are combined to rotate, reciprocate, or otherwise operate. In addition to suppressing friction and wear, this oil also suppresses corrosion and frictional heat, and its sealing and cleaning properties allow the machine to operate smoothly. Lubricating oil formulated with PFAS have the following characteristics Low friction: Reduces the adverse effects of friction on the lifetime and performance of components. Heat resistance: Resistance to chemical changes even when used in high-temperature environments. Resistance to ignition. Weatherability: Excellent oxidation stability and resistance to adverse effects of oxygen. Not decomposed by moisture. Chemical resistance: Resistant to chemicals such as acids and alkalis. Chemical resistance/cleanliness: Almost no deterioration of rubber and plastic materials. There is no other lubricant besides fluorinated synthetic lubricants that can satisfy all of the above characteristics. Lubricant oils in the products. (AB) Mass Flow Controller / Mass Flow Meter Mass flow controllers and mass flow meters are used for flow control and flow measurement of various industrial gases. Lubricating oil is applied to joint screws and O-rings to prevent screw galling and improve the assembly of O-rings. Figure 45 screw Ordinary grease and oil cannot be used because they may become a source of ignition when flammable oxygen gas is used, so their safety is significantly impaired. 51 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan (AB)Pressure Transmitter 1)Measuring Principal A pressure transmitter consists of a barrier diaphragm that contacts the process pressure, a center diaphragm that protects the sensor, and a sensor that detects the pressure. If there is a difference in pressure on each barrier diaphragm, the fill fluid that carries the pressure creates a pressure difference on either side of the sensor, which distorts the sensor and changes its resistance. Measure the pressure by converting the resistance change of the sensor. Standard type High Pressure Sensor Low Pressure Center Diaphragm Remote type Barrier Diaphragm Yellow and orange area mean fill fluid Pressure Figure 46 52 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan In addition to the following items, the properties required for the fill fluid include fluidity even at low temperatures, low viscosity, and nonflammability. The only fill fluid that offers all of these is the fluorinated fill fluid, and there is no alternative. The diaphragms that come into contact with process fluids may be damaged due to corrosion or abrasion during use. When broken, the fill fluid comes into direct contact with the process fluid, but otherwise does not leak into the environment. This product is a WEEE target model and is in a controlled state for disposal. Since the fill fluid is in direct contact with the sensor, high electrical insulation performance is required. PCTFE can use up to 120 degree Celsius, Perfluoropolytrimethyleneoxide can use up to 260 degree Celsius. Stable against strong corrosive acids and alkalis. Does not react with chlorine and oxygen even under high temperature and pressure. Surface tension:2628N/m Silicon oil: Most likely fill fluid but reacts with chlorine and oxygen at high temperatures and pressures, and in the worst cases explodes. (AB) Coding for sliding rubber parts of industrial controllers A PTFE-coated lubricant is applied to the outer circumference of the packing to make it easier to separate the front bezel from the case. Since the housing is made of resin, there is a risk of solvent cracking, and grease cannot be used. Figure 47 Overall product Figure 48 Packing installation explanatory diagram 53 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Others (AB) Limit switch button, housing and rubber seal 1Internal switch button 2Painting the housing 3Used for each rubber seal of limit switch Figure 49 Although the exterior coating can be changed to other coatings, fluorine is the lowest and most suitable for internal sliding properties. Slidingplunger and housing Sliding: internal switch button and internal switch cover Addition of fluorine improves slidability. Dynamic friction coefficient (ud) Heatresistant( degree Celsius) Fluoropolymer PTFE 0.09 260 Table 17 18 Resin PE 0.13 70-110 POM 0.18 80-120 18 https://www.y-skt.co.jp/magazine/coating/lowfriction/ 54 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan The retention of seals at high temperatures is superior to other rubbers. Switching to silicone rubber is difficult to adopt because of the risk of contact failure. In addition, it is often used for applications such as cutting fluid that damage silicon rubber, so it cannot be used. (AB)Liquid leak sensor Liquid tank Liquid leak sensor The sensor housing is made of PFA resin. Figure 50 Schematic diagram of sensor structure The sensor housing cover, case and tube are made of PFA resin. Figure 51 55 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Due to the housing made of PFA resin, this leakage sensor has higher stability against organic solvents than other products. The following characteristics can be obtained by using PFA resin for the leakage sensor. - This leakage sensor functions stably for the detection of organic solvents. This leakage sensor is used for the following applications. - Liquid leakage detection in semiconductor wafer cleaning and developing processes - Detection of tank leakage There are concerns about the following effects due to the unavailability of this technology : - Cleaning and development of a semiconductor wafer using an organic solvent cannot be carried out safely. (KM) Reserver for adding pressure Ultrasound Probe In ultrasonic probes, when the acoustic coupling medium expands as a result of temperature changes, the internal pressure of the medium chamber may increase excessively. It results in damage to the sealing part of the medium chamber and possible air bubble contamination. Resin is used as the material that makes up the media chamber because of its acoustic properties. Even if the media chamber is sufficiently sealed, during long-term use, the pressure inside the media chamber gradually decreases due to elongation caused by the creep phenomenon of the resin. As a result, the pressure inside the media chamber becomes lower than the external pressure, and air may permeate through the resin that constitutes the media chamber. If air bubbles are introduced into the media chamber, they become reflectors of ultrasound waves, which inhibits ultrasound transmission and reception. As a result, the ultrasound image is degraded. In this type of ultrasonic probe, it is necessary to adjust the pressure in the media chamber to suppress the generation of bubbles, and fluorine rubber, which has low permeability to gases and liquids, is used to achieve this objective. 56 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Cross-sectional view of an ultrasonic probe coupling liquid Reserver for adding pressure Image of Reserver for adding pressure (A)adding pressure (B) unpressurized Figure 52 Period required for replacement: About 1 years, if a non-fluorine material with PFAS-equivalent performance is produced. (KM) Mold release coating for the injection molding of plastic lenses In the injection molding of plastic lenses and lens unit housings, we use a mold release coating on the surface of the mold to prevent the plastic from sticking to the mold during removal from the mold (mold release) after filling the mold with plastic. Thereby, it can improve moldability. The type of PFAS for the release coating is not disclosed due to confidential information. If this release film is not coated, the yield of the molding process will be less than 10%. The reasons why release coating is especially necessary for plastic lenses and lens unit housings are as follows. Effect on lens optical performance If the next injection molding is performed with plastic adhering to the mold, the part of the molded product corresponding to the part of the mold to which the plastic has adhered will be transferred in the shape of the adhered plastic, creating a dent in the molded product. Especially in the case of lenses, if even a part of the lens is dented, optical performance is greatly affected and the product becomes defective. 2. Decreased production efficiency When resin adheres to the mold, molding must be stopped and the adhered resin removed from the mold. If this frequency is high, production efficiency will decrease. Plastic lenses also tend to adhere, mainly because of the following reasons: 57 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan 2-1. Since the required shape accuracy is very strict, the pressure to transfer to the mold must be high. As a result, the resin tends to stick to the mold during mold release more than other plastic parts. 2-2. Dirty mold surfaces due to continuous molding make it easy for resin to adhere to the surface. (KM) Standard white calibration plate (Colorimeters) Colorimeters, which measure and quantify color, are widely used for quality control of "color" of products and materials in various industries, such as automobiles, information appliance (IA), cosmetics, and apparel, to improve management efficiency and quality. A high-performance colorimeter measures the reflectance at each wavelength (360 to 740 nm for visible light) by spectroscopy of the light reflected from the object being measured at each wavelength. To obtain accurate measured color values, it is necessary to calibrate the measurements when starting up the colorimeter and in some cases once every few hours, and a white calibration plate is used for this purpose. A white calibration plate is a standard reflector with a pre-valued reflectance, which must have a reflectance of at least 95% (ideally 100%) at all measurement wavelengths. Crystalline PTFE is used as the standard reflective calibration plate. PFAS functions required by standard reflective calibration plates and the possibility of alternatives White calibration plates (standard reflectors) need lots of requirements as follows; high reflectance (95% or higher) in all visible light ranges as described above, as well as material stability, such as stability under various conditions of use, suppression of surface degradation (decrease in reflectance) due to light exposure and aging, and no change in reflectance due to cleaning using chemical products (e.g. silicone solvent). 58 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Figure 53 UV Reflectance Comparison 19 Most of the white reflective calibration plates used in current products are made of leaded ceramics. Lead is an exempted use (category 9, 13b) of the RoHS Directive, but this is expected to expire soon. After the expectation, we have searched for an alternative for a long time, and PTFE is the only material that satisfies the requirements. There are currently no alternatives to PTFE, except for leaded ceramics, which will be regulated by the RoHS Directive. (RK) Cutting parts (Example of finished products: diaphragm galvanic oxygen sensors, oxygen detectors) It is a part manufactured by cutting a block of resin. Because it is a small-lot production product, it is produced by cutting that does not require mold costs. Another reason for cutting is that there are places where sealing properties are required. Here, I will touch on the machined parts used in the casing of the galvanic oxygen sensor. There are various materials, but we will describe the case where PTFE and PFA, which have higher chemical resistance, are used. 19 https://www.thorlabs.co.jp/newgrouppage9.cfm?objectgroup_id=13871#:~:text=%E3%83%9D%E3%83%AA%E3%83%86% E3%83%88%E3%83%A9%E3%83%95%E3%83%AB%E3%82%AA%E3%83%AD%E3%82%A8%E3%83%81%E3%83%A C%E3%83%B3(PTFE,%E3%82%88%E3%82%8A%E3%82%82%E5%84%AA%E3%82%8C%E3%81%A6%E3%81%84%E 3%81%BE%E3%81%99%E3%80%82 last accessed on June 11 2023 59 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Figure 54 Example of Fluoroplastic Cutting Parts Please see "Membrane filters" for galvanic oxygen sensors Fluoropolymer casing are required when parts require chemical resistance. There is a need to measure oxygen concentration even in places where acids, alkalis, and organic solvents are always present. In this application, it is necessary to have chemical resistance such that it does not deteriorate even when it comes into contact with various gases (acids, alkalis, organic solvents), does not elute components even when it comes in contact with any sample. Also, as a material, it is necessary to have weather resistance properties such as not changing in a 10-year exposure test and not softening or deforming in the surrounding environment of -40 to 70 C. If you try to perform the same function with other materials, for example, phenolic resins and polyamide resins can be mentioned as resins that are resistant to acetone as a general organic solvent, but phenolic resins are resistant to strong alkalis. Polyamide-based resins cannot be used as a substitute because they do not have durability against strong acids. (AB) Sapphire Capacitance Diaphragm Gauge Components corresponding to a heater operating temperature of MAX 250C For the picture of this products, please see the explanation in electric wires and insulation. Components compatible with gauge head operating temperature of MAX 250C 60 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan LEMO connector Board connection cable Cable jacket and dielectric contain Perfluoroalkoxy alkane(PFA) Sensor, Temperature sensor for control Board connection cable Sheath, insulator, etc. contain Perfluoroalkoxy alkane(PFA) Figure 55 (AB) Humidity element for humidity sensor and dew point temperature sensor Sector "Electronics and semiconductors (Annex E.2.11.)" "Construction products (E.2.13.)" Sub uses :Monitoring and control instruments Heating, Ventilation and Air Conditioning(HVAC) Polymeric PFAS /Fluorinated polyimide Generic name for the final product: Humidity sensor, Dew point temperature sensor Common name for application parts: Humidity element Detailed application description: The humidity sensor chip used for a humidity sensor and a dew point temperature sensor measures humidity by capacitance change between electrodes sandwiching the moisture sensitive film. The thickness of the moisture sensitive film is several m. 61 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Schematic diagram of sensor chip structure Polymer moisture-sensitive membrane is made of fluorinated polyimide Figure 56 This humidity sensor is used for the following purposes Humidity sensor installed in an environment in which condensation appears on the sensor itself, such as inside the HVAC duct and the outside air intake section. The following features can be obtained by using fluoride polyimide for humidity sensor The humidity sensor works stably for a long period in an environment where the sensor is condensed (100% humidity). Nothing to replace this function. The humidity sensor has higher stability under high temperature, high humidity and condensation than other products due to the humidity sensitive membrane using fluorinated polyimide. The prohibition of this technology is concerned about the following effects. It won't be able to properly measure and control humidity on HVAC system in an environment in which condensation appears on the sensor itself. Other polymer materials such as methyl methacrylate resin (PMMA), polyimide, polysulfone, etc. can be candidates as alternative technologies and materials. However alternative technology requires replacement of the sensor every time condensation occurs. For example, it is known that condensation appears on a humidity sensor which is inserted into an outside air intake duct several times a year depending on the weather. Humidity sensors without moisture sensitive membrane using fluorinated polyimide for this application will require replacement at least once a year. Moisture sensitive membranes using fluorinated polyimide can withstand at least 8 years of use. 62 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Performance requirements for materials (PFAS) Heat-resistant: 180 degree Celsius as a humidity sensitive element Repellency from water: Electrical insulation in condensing environments Chemical resistance: Resistant to organic solvent atmosphere Alternative Considerations: No substitute material Required derogation period: 13.5 years or more (AB) Valve for air volume and room pressure control Materials for ensuring sliding, corrosion resistance, chemical resistance, and solvent resistance for air volume valves. Use sector: "Medical devices (Annex E.2.9.)", "Construction products (E.2.13.)" sub-uses: Control valve, Heating, Ventilation and Air Conditioning(HVAC) PFA26655-00-5 PTFE9002-84-0 PVDF24937-79-9 ETFE25038-71-5 Generic name for the final product: Valve for air volume and room pressure control Common name for application parts: Body, Pivot arm, S-link, Shaft, Spring, Cone, Brackets, Seal), Tap, e-crip), Bush, Slider, Sleeve, Cap, Bolt Detailed application description The two main applications of valves are below. (1) To be installed as a local exhaust ventilation system to prevent workers from being exposed to substances harmful to the human body, such as in chemical manufacturers and biotechnology research laboratories. For example, when a worker opens or closes the door of the local exhaust device (red dotted frame in Figure 57), the differential pressure across the valve suddenly changes, but by taking advantage of the good sliding property, the valve can be instantly changed to the appropriate valve opening position to maintain exhaust at a constant air volume. In addition, since valves must control fluids containing various chemicals and solvents, they must be resistant to corrosion, chemicals, and solvents. 63 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Flexible hood Arm hood Chemical storage bottle cabinet Ventilated sink Sink hood photo from the website of Dalton Corp, and AS ONE Corp. Figure 57 Example of air volume control in a chemical/ Other exhaust applications (2) The device is installed in hospital rooms and wards as a negative-positive pressure control device to secure hospital beds for patients with infectious diseases and to protect healthcare workers from infection risk. Even when the differential pressure across the valve suddenly changes due to the opening and closing of the hospital room entrance door, etc., the air supply and exhaust valves respond instantly by taking advantage of their good sliding characteristics and change to the appropriate opening position, thereby always maintaining the pressure difference between the room and outside. Figure 58 Image of negative and positive pressure control in a hospital room 64 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan The parts used in valves that include candidates for regulation are below. Seal,Tap Bush Figure 59 Valve image Slider Bolt E-crip Sleeve Ca Figure 60 Slider assembly (1) For valves that do not require corrosion resistance, chemical resistance, or solvent resistance, parts (Slider, Sleeve, Cap) containing PTFE should be used to ensure sliding properties. (2) Valves that require corrosion resistance, chemical resistance, and solvent resistance use the following parts to ensure the above three functions and sliding properties. Parts containing PTFE (Slider, Sleeve, Cap, Bush, Seal, Tap) Parts containing PFA (Shaft, Spring) Parts containing PVDF or ETFE (Body, Pivot arm, S-link, Cone, E-crip, Bolt) Technical Description of Essential Uses As mentioned above in "Detailed application description", valves must have the sliding property required to respond instantly to sudden disturbances, and the corrosion, chemical, and solvent resistance required to control fluids containing various chemicals and solvents. Therefore, it is necessary to place parts containing PTFE, PFA, PVDF, and ETFE for mechanisms that need to ensure sliding properties and for channel parts that are in contact with the control fluid. 65 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan (1) Ensure sliding properties Other polymeric materials may be used as an alternative to PTFE for ensuring sliding properties. However, since there is no material with lower sliding resistance than PTFE, the sliding resistance force will increase, and the sliding performance required for valves cannot be ensured. (2) Ensure sliding properties, corrosion resistance, chemical resistance, and solvent resistance Other polymeric materials, such as rubber and resin, may be used as alternatives to PFA, PTFE, PVDF, and ETFE for the purpose of ensuring the above four functions. However, the alternative materials cannot ensure the sliding properties, corrosion resistance, chemical resistance, and solvent resistance required for valves due to the deterioration of sliding properties as described in (1) and the lack of resistance to various chemicals and solvents. The following effects are feared as a result of the unavailability of these technologies. The inability to use PFA, PTFE, PVDF, and ETFE for valves will make it impossible to carry out normal operations at chemical manufacturers, biotechnology research facilities, hospitals, and other facilities. This will have a profound impact on the production and supply of medicines, the progress of research in biotechnology, and isolated medical treatment, including coronas. For the above reasons, the prohibition of the use of parts containing PFA, PTFE, PVDF, and ETFE in valves should be exempted from this restriction in terms of ensuring safety for the human body. In terms of disposal, the restriction should not be applied to valves containing PFA, PTFE, PVDF, and ETFE, since these components can be used until the product reaches its original service life, leading to a reduction of waste in general. Performance requirements for materials (PFAS) Heat-resistant: Heat-resistant max93 degree Celsius chemical resistance: Resistant to chemicals, solvents and corrosive fluids Sliding performance: Wear resistance due to sliding, sliding performance Non-adhesion: Non-adhesion of foreign matter (ID) Mechanical parts for sliding or releasing applications used in "Specialist equipment" Fluoropolymers with excellent low friction, and self-lubrication and mon-adhesion. properties are often used in mechanisms that require sliding with plastic and metal parts or releasing from sticky materials.. The following common characteristics are related to the reason why fluoropolymers are particularly selected for "Specialist equipment". 66 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan 1) Some final products handled by "Specialist equipment" require use in special environments. For example, in facility environments where foods, liquids, powders, etc. are handled, consideration must be given to high temperature, high humidity, generation of dust, or hygiene management. 2) Equipment used in social infrastructure such as factories is required to have performance such as automatic operation, trouble-free operation, easy preparation and setup changes. This enables us to provide society with high-quality, low-cost products and services. 3) When handling products with equipment, it is required to minimize the impact on product quality, such as damage or adhesion of foreign matter. From the above, the mechanical parts for sliding applications used in " Specialist equipment " are required to have the following properties. Repellency from water and oil / non-adhesion Low friction, self lubrication Heat resistance Chemical resistance (Acid resistance, Alkali resistance, Oil resistance, Ozon resistance) Table 18 summarizes the performance of major alternative materials with respect to the required performance. Material Material or Coating Low Coefficient friction of friction Repellency Contact from water angle of and oil water [deg] adhesion energy [dyne/cm] Oil Contained in resistance food Acid Contained in resistance food Alkali Contained in resistance detergents, etc. Ozon Special resistance cleaning Heat Hot food resistance Table 18 PTFE Material/ Coating 0.04 114 43.1 POM Material 0.2~0.3 Equivalent to PA66 HDPE Material/ Coating 0.2~0.3 88 75.2 ~ ~ PA66 Material/ Coating 0.18~0.4 77 97.7 ~ * Non-adhesion and Repellency from water and oil are according to the above-mentioned property table. Others are summarized by the author of this section based on multiple documents. 67 / 68 SEAJ as of 12th September 2023 SEAJ from Electric equipment manufacturers' coalition of medical devices, and analysis, measurement, test,control and monitoring instruments in Japan Appropriate materials are selected and used according to the required performance that varies depending on the work environment and target product. From the table, PFAS shows good properties with respect to water/oil repellency and heat resistance. Cases where PFAS is used as an irreplaceable material include, for example, use in environments where food and liquids are handled, as well as guide parts or blade surface coatings where adhesion is undesirable. Instrument example (Packaging machine for food industries) Figure 61 Heating pressure bar with knife of packaging machine (with PTFE Coating) 68 / 68