Abstract This specification covers polysulfone resin (poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-p-phenylene)) for medical applications. Requirements and associated test methods for a form of this thermoplastic intended for use in manufacturing medical devices or components of medical devices are provided. The use of this resin in medical devices should be restricted to nonimplant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed. The molecular weight of the resin shall be determined by osmotic pressure in monochlorobenzene. The polysulfone resin shall yield an infrared transmittance spectrum that exhibits major transmittance bands only at the same wavelengths as that of a reference spectrum. Medical devices made of polysulfone may be repeatedly sterilized through steam, ethylene oxide, irradiation, and dry heat sterilization, among others. The polysulfone resin shall be tested for nonvolatile content and melt flow, and shall conform to the specified electrical, physical and mechanical, and thermal properties.Scope 1.1 This specification covers polysulfone resin (poly(oxy-1,4-phenylenesulfonyl-1,4–phenylene (dimethylmethylene)-1,4–phenylene)) as defined in ISO 25137–1, supplied by a vendor in virgin form (pellets, powder, fabricated forms and so forth) for medical applications. This specification provides requirements and associated test methods for this thermoplastic when it is intended for use in manufacturing medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using test methods which are appropriate to ensure safety and efficacy as agreed upon by the vendor, purchaser, and regulating bodies. 1.3 The standard allows for designation of polysulfone resin for all medical applications. The actual extent of performance and suitability for a specific application must be evaluated by the vendor, purchaser, and regulating bodies. 1.4 The properties included in this specification are those applicable for unfilled polysulfone (PSU) polymers with the addition of colorants and processing aids. Indicated properties are for injection molded forms. Forms containing fillers or other additives, as well as polymer blends which contain PSU, or reclaimed materials, are not covered by this specification. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. This standard does not purport to address all of the concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

American National Standards Institute Inc.

Go to ASTM F702 at ASTM.org

Add your thoughts about the standard.

1375 - Demolition Materials (549) 1377 - Cartridge and Propellant Actuated Devices and Components (524) 4720 - Hose and Flexible Tubing (552) 4730 - Hose, Pipe, Tube, Lubrication, and Railing Fittings (1823) 5120 - Hand Tools, Nonedged, Nonpowered (1124) 5305 - Screws (781) 5306 - Bolts (996) 5310 - Nuts and Washers (864) 5330 - Packing and Gasket Materials (583) 5340 - Hardware, Commercial (953) 5905 - Resistor (753) 5910 - Capacitors (783) 5930 - Switches (1012) 5935 - Connectors, Electrical (4357) 5940 - Lugs, Terminals, and Terminal Strips (564) 5945 - Relays and Solenoids (733) 5950 - Coils and Transformers (856) 5960 - Electron Tubes and Associated Hardware (1630) 5961 - Semiconductor Devices and Associated Hardware (707) 6145 - Wire and Cable, Electrical (1629) 6240 - Electric Lamps (662) 6505 - Drugs and Biologicals (1343) 6515 - Medical and Surgical Instruments, Equipment, and Supplies (1907) 6520 - Dental Instruments, Equipment, and Supplies (790) 6530 - Hospital Furniture, Equipment, Utensils, and Supplies (745) 6610 - Flight Instruments (540) 6625 - Electrical and Electronic Properties Measuring and Testing Instruments (1241) 6640 - Laboratory Equipment and Supplies (1187) 6810 - Chemicals (1114) 8010 - Paints, Dopes, Varnishes, and Related Products (2046) 8030 - Preservative and Sealing Compounds (554) 8140 - Ammunition and Nuclear Ordnance Boxes, Packages and Special Containers (797) 8305 - Textile Fabrics (910) 8415 - Clothing, Special Purpose (660) 8455 - Badges and Insignia (3093) 8915 - Fruits and Vegetables (531) 9330 - Plastics Fabricated Materials (759) FACR (1647) ISDA (1776) ISDD (786) ISDF (1827) ISDN (581) MISC (1045) PACK (539) SESS (581)
Aerospace Material (225) Aircraft Air Conditioning, Heating, and Pressurizing Equipment (334) Aircraft Hydraulic, Vacuum, and De-icing System Components (263) Ammunition, 75mm through 125mm (192) Ammunition, over 30mm up to 75mm (208) Ammunition, through 30mm (349) Analytical Chemistry (180) Bombs (192) Building (414) Bulk Explosives (261) Cartridge and Propellant Actuated Devices and Components (524) Consumer Product Evaluation (267) Copper (192) Demolition Materials (549) Electrical and Magnetic Conductor (162) Electronics (153) Environmental Toxicology (187) Fire Control Computing Sights and Devices (338) Fire Control Radar Equipment, except Airborne (197) Fuzes and Primers (454) Geotechnical Engineering (217) GUN (640) Land Mines (276) Medical Device and Implant (427) Military Chemical Agents (156) Miscellaneous Aircraft Accessories and Components (231) Miscellaneous Fire Control Equipment (216) Nondestructive Testing (246) Nonferrous Metal and Nonferrous Alloy (367) Nuclear Technology (274) Optical Sighting and Ranging Equipment (451) Paint and Related Coating (456) Parachutes; Aerial Pick Up, Delivery, Recovery Systems; and Cargo Tie Down Equipment (324) Petroleum (378) Plastic Pipe (248) Pyrotechnics (175) Road and Paving (177) Rockets, Rocket Ammunition and Rocket Components (368) Rubber (166) Security System Pedestrian and Walkway Safety (157) Specialized Test and Handling Equipment, Nuclear Ordnance (150) Sports and Recreation (316) Steel (908) Torpedos and Components, Inert (258) (621)