Document MMYbnRMN0brD25J2aYydV1yRM
Non-confidential attachment of PFAS public consultations
PP-SFP-IPD-Med 24/Aug/2023
Irradiated Products Division Sumitomo Electric Fine Polymer, Inc.
Typical application of heat-shrinkable tubing for electric scalpel
Typical application for medical electric scalpel
Comparison table of PFAS(PVDF) and its alternatives in the proposed restrictions
Materials
PVDF
EPDM
Silicone
PEEK
Mica
Polyvinyl Polyethylene Ceramic
chloride
Based
Flexibility
Semi rigid
Continuous use temperature() Oil resistance Abrasion resistance Flame-retardancy ISO10993 Heat Shrinkable Tubing (Shrink ratio)
180
Excellent Excellent Excellent
Yes Possible (min.50%)
Flexible
90
Poor Poor Poor No Possible (50%)
Flexible
180
Poor Poor Good No Possible (50%)
Rigid
260
Excellent Excellent Excellent
Yes Possible (40)
Rigid
500(Mica) Excellent Excellent Excellent
No Impossible
Flexible Semi rigid
100
Poor Good Good
No Possible (min.50%)
Flexible Semi rigid
120
Good Good Poor Yes Possible (min.50%)
Rigid
500
Excellent Excellent
Good No
Impossible
Comparison of properties between [PVDF] and other PFAS alternatives. Gray shaded cells are issues when substituting PVDF heat-shrink sleeve. "ISO10993" is a standard for medical equipment, basically no additives required As for the alternative of PVDF heat shrink sleeve for medical equipment (electric scalpel), PEEK could be candidate for alternative, but PEEK has only 40% shrink ratio (inside diameter 1.4:1 shrink) to have following difficulties
1) narrow range of size for fittable to an object 2) less clearance between inside diameter of sleeve and an object, which give difficulty in inserting the object into sleeve especially in long length
Shrink ratio: (D-d)/D *100 (%)
where as D: Inside diameter before shrink d: Inside diameter after shrink
before shrink
after shrink
An example of fire accident while operating with electric scalpel
(*)https://pubmed.ncbi.nlm.nih.gov/17571619/, non-confidential attachment
Typical PEEK heat-shrinkable tubing in the market
PEEKhrink
Heat-Shrinkable Tubing for Challenging Environmeits
All PEEKshrink is Custom Ordered
WWW.ZEUSINC CONI
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Features: Continuous service temperature 500F/260C Translucent recovery shrink temperature 572F - 644F (300C - 340C) Opaque recovery shrink temperature 680F - 725F (360C - 385C) Recovered wall range of 0.004- to 0.010- (0.102 to 0.254 mm)
Applications: Electrical component covering Protective jacketing Wire Splicing
Reusable medical devices
Benefits: Excellent abrasion resistance Extends life of the protected item Adhesion to metals Available in colors
Technical Notes: Zeus will assist in developing custom
heatshrink processes Class VI approved materials
PEEKshrink' 1.4:1 Heat Shrinkable AWG Tubing
Zeus P/N
Ordered as AWG Silo
As Supplied Inside DiamOUWNIP
Recovered Dimension After Shrinking
Wall Thickness
Recovered ID
Max
Minimum
Nominal
85322
' -
C.C38
0.027
0.005
C.CC7
85318
16
0.045
0.032
0.005
0.007
85184
15
0.055
0.039
0.005
0.007
85204
14
0.085
0.060
0.005
0.007
85197
13
0.092
0.065
0.005
0.007
85189
12
0.101
0.072
0.005
0.007
85313
11
0.1 12
0.080
0.005
0.007
85310
10
0.125
0.089
0.005
0.007
85298
9
0.137
0.098
0.005
0.007
85294
8
0.160
0.114
0.005
0.007
85146
7
0.174
0.124
0.005
0.007
85063
6
0.200
0.143
0.005
0.007
85213
5
0.221
0.158
0.005
0.007
85236
4
0.252
0.180
0.005
0.007
85243
3
0.277
0.198
0.005
0.007
85246
2
0.316
0.226
0.005
0.007
85255
1
0.349
0.249
0.005
0.007
85326
0
0.392
0.280
0.005
0.007
PACKAGING: Vonocro Aft lengths. Custom :e: and lengths ovolobie upon requev..
Maximum
C.CC9 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009 0.009
Catalog from Zeus: https://www.zeusinc.comiwp-content/uploads/2023/03/Zeus-Catalog-G-V1R6.pdf showing PEEK shrink tube has [ 1.4 : 1 ] shrink ratio = 40% shrink ratio
Material price comparison between PVDF and PEEK
Material price comparison between PVDF and PEEK PEEK is 10 times higher than PVDF in raw material. (process cost is not displayed here)