Document kq8e311jpXEbX2Ge1K1Zenq0

OECD polymer of low concern (PLC) criteria add 2021 W.L. Gore Associates OECD = Organisation for Economic Co-operation and Development Polymer T8 T4 T8W T4W E4W E8W Soft P2 P2 FKM FFKM FEPM ECTFE Polymer composition MW, Mn, MWD Wt-% oligomer Electrical charge Reactive functional groups (RFG) Fluoropolymer PTFE TFM-PTFE PFA FEP Alternative Materials PEEK PAEK PPS PI PAI Symbols Legend Polymer composition MW, Mn, MWD Wt-% oligomer Electrical charge Reactive functional groups (RFG) Functional group equivalent weight (FGEW) Low MW leachables Water/lipid solubility,octanol water partition Polymer composition, structure & elemental composition; including CAS no. Number average molecular weight and oligomer content are used criteria for PLC assessment. MWD Weight % of oligomers < 1000 Da El. Ch. or ionic character can be: anionic, cationic, amphoteric, nonionic; cationic polymers associate Atom or associated group of atoms in a chemical structure that is intended or can be reasonable ex FGEW is defined as the ratio of Mn to the number of functional groups in the polymer Are chemical molecules, either inorganic or organic, that migrate (i.e. leach) out of the polymer Water solubility = extent to which a compound will dissolve in water; negligible water solubility < 1x Particle size Polymer stability Thermal stability Abiotic stability Biotic stability Particles that are small enough to reach the deep lung upon inhalation are associated with adverse Resistance to physical, chemical, biological transformation. Breaking down into smaller particles is c To be assessed when used as intended or in extreme temperature during dosposal. Theermal stabil Polymers are stable, monomers are not. Abiotic degradaton may involve sunlight, water or oxygen. Is assessed by whether the polyymer is degraded by microorganisms under oxygenated (aerobic) or Functional group equivalent weight (FGEW) Low MW leachables Water/lipid solubility,octanol water partition Particle size Polymer stability Thermal stability riteria for PLC assessment. MWD --> polydispersity index onic; cationic polymers associated with aquatic toxxicity ntended or can be reasonable expected to undeergo facile chemical reaction ups in the polymer e. leach) out of the polymer r; negligible water solubility < 1x10E-6 mg/L = 1 ppt tion are associated with adverse health effects. Polymer particles should be > 5 m g down into smaller particles is ccritical. Molecules with Mn<1000 Da are capable of crossing cell membranes during dosposal. Theermal stability testing may involve TGA volve sunlight, water or oxygen. s under oxygenated (aerobic) or anoxic ( anaerobic) conditions Abiotic stability Biotic stability Coeff of Friction Chemical Compatibility