ASTM-F1855 › Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
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Scope
1.1 This specification covers polyoxymethylene (acetal) resin for medical applications. This specification provides requirements and associated test methods for a form of this thermoplastic which is intended for use in manufacturing medical devices, instrumentation or components there of.
1.2 As will any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, etc.) required for a specific application. Therefore properties of fabricated forms of this resin should be evaluated using appropriate test methods to assure safety and efficacy.
1.3 Although this resin has been used and for specific implant applications in the United States, the use of this resin in medical devices should be restricted to non-implant applications until biocompatibility evaluations appropriate for the intended applications are successfully completed.
1.4 The biocompatibility of plastic compounds made up of polyoxymethylene (acetal) resin containing colorants, fillers, processing aids, or other additives as well as polymer blends which contain polyacetal should not be assumed on the basis of resin biocompatibility alone. Their biocompatibility must be established by testing the final (end-use) compositions using evaluation methods appropriate for the intended applications. It should be noted that the types, test levels and biological effects of extractives yielded by the additives contained in a compound or blend may also have to be evaluated for some end-use applications.
Keywords
acetal; copolymer; homopolymer; polyoxymethylene; thermoplastic resin; ICS Number Code 11.040.30 (Surgical instruments and materials); 83.080.20 (Thermoplastic materials)
To find similar documents by ASTM Volume:
13.01 (Medical and Surgical Materials and Devices)
To find similar documents by classification:
11.040.30 (Surgical instruments and materials Including surgical dressings, sutures, etc.)
83.080.20 (Thermoplastic materials)
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Document Number
ASTM-F1855-00R19
Revision Level
2000 R19 EDITION
Status
Current
Modification Type
Revision
Publication Date
Dec. 23, 2019
Document Type
Specification
Page Count
3 pages
Committee Number
F04.11