ASTM F1855-00

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Designation: F 1855 – 00
Standard Specification for
Polyoxymethylene (Acetal) for Medical Applications
This standard is issued under the fixed designation F 1855; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D 883 Terminology Relating to Plastics
D 1600 Terminology for Abbreviated Terms Relating to
1.1 This specification covers polyoxymethylene (acetal)
Plastics
resin for medical applications. This specification provides
F 748 Practices for Selecting Generic BiologicalTest Meth-
requirements and associated test methods for a form of this
ods for Materials and Devices
thermoplastic which is intended for use in manufacturing
medical devices, instrumentation or components there of.
3. Chemical Composition
1.2 As will any material, some characteristics may be
3.1 The chemical composition of the material shall conform
altered by the processing techniques (such as molding, extru-
to Specification D 4181. The FTIR spectrum of the material
sion, machining, sterilization, etc.) required for a specific
must be consistent with a reference or standard piece of the
application. Therefore properties of fabricated forms of this
appropriate grade of the polymer. It may be helpful for the
resin should be evaluated using appropriate test methods to
reader to review standards D 883 and D 1600 for clarification
assure safety and efficacy.
of terminology.
1.3 Although this resin has been used and for specific
3.2 Class 1, Grade 1 of polyoxymethylene of Group 1, 2, or
implant applications in the United States, the use of this resin
3 (as described in ASTM D 4181), is recommended for use in
in medical devices should be restricted to non-implant appli-
medical applications, however other grades of this polymer
cations until biocompatibility evaluations appropriate for the
may be found to be acceptable through appropriate testing.
intended applications are successfully completed.
1.4 The biocompatibility of plastic compounds made up of
4. Physical Properties
polyoxymethylene (acetal) resin containing colorants, fillers,
4.1 The mechanical properties of the material shall conform
processing aids, or other additives as well as polymer blends
tothoselistedinSpecificationD 4181fortheappropriategrade
whichcontainpolyacetalshouldnotbeassumedonthebasisof
and class of polymer being evaluated. Table 1 provides typical
resin biocompatibility alone. Their biocompatibility must be
values for both physical and mechanical properties of medical
established by testing the final (end-use) compositions using
grade polyoxymethylene (Acetal) for medical applications.
evaluationmethodsappropriatefortheintendedapplications.It
should be noted that the types, test levels and biological effects
5. Inspection and Certification
of extractives yielded by the additives contained in a com-
5.1 The following information shall be reported in the
poundorblendmayalsohavetobeevaluatedforsomeend-use
material certification: Grade and color identification (that is,
applications.
color number).
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
NOTE 1—Some coloring agents have the potential to elicit an adverse
biological response, therefore any grades containing pigments, dyes, or
responsibility of the user of this standard to establish appro-
additives should be separately evaluated for biocompatibility as appropri-
priate safety and health practices and determine the applica-
ate for the particular application.
bility of regulatory limitations prior to use.
6. Biocompatibility
2. Referenced Documents
6.1 Biocompatibility of acetal resins and implant devices
2.1 ASTM Standards:
made using these materials shall be determined in accordance
D 4181 Specification forAcetal (POM) Molding and Extru-
with Practice F 748, unless otherwise agreed upon by packager
sion M
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