ASTM F1855-00(2011)

Standard Specification for Polyoxymethylene (Acetal) for Medical Applications

ABSTRACT
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 thereof. Physical and mechanical properties of medical grade polyoxymethylene such as specific gravity, water absorption, equilibrium, tensile yield strength, tensile elongation break, tensile modulus, tensile impact strength, compressive strength, and sheer strength shall be determined. Biocompatibility of acetal resins and implant devices made using these materials shall also be determined.
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 thereof.
1.2 As will any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, sterilization, and so forth) 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.
1.5 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Nov-2011
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 83.080.20 - Thermoplastic materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F1855-00(2005) - Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
• Effective Date: 01-Dec-2011
• Replaced By: ASTM F1855-00(2019) - Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
• Effective Date: 01-Dec-2019
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Dec-2011

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1855 −00 (Reapproved 2011)
Standard Specification for
Polyoxymethylene (Acetal) for Medical Applications
This standard is issued under the fixed designation F1855; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
1.1 This specification covers polyoxymethylene (acetal) 2.1 ASTM Standards:
resin for medical applications. This specification provides D4181 Classification for Acetal (POM) Molding and Extru-
requirements and associated test methods for a form of this sion Materials (Withdrawn 2005)
thermoplastic which is intended for use in manufacturing D883 Terminology Relating to Plastics
medical devices, instrumentation or components thereof. D1600 Terminology forAbbreviatedTerms Relating to Plas-
tics
1.2 As will any material, some characteristics may be
F748 PracticeforSelectingGenericBiologicalTestMethods
altered by the processing techniques (such as molding,
for Materials and Devices
extrusion, machining, sterilization, and so forth) required for a
specific application. Therefore properties of fabricated forms
3. Chemical Composition
ofthisresinshouldbeevaluatedusingappropriatetestmethods
3.1 The chemical composition of the material shall conform
to assure safety and efficacy.
to Specification D4181. The FTIR spectrum of the material
1.3 Although this resin has been used and for specific
must be consistent with a reference or standard piece of the
implant applications in the United States, the use of this resin
appropriate grade of the polymer. It may be helpful for the
in medical devices should be restricted to non-implant appli-
reader to review Terminology D883 and Terminology D1600
cations until biocompatibility evaluations appropriate for the
for clarification of terminology.
intended applications are successfully completed.
3.2 Class 1, Grade 1 of polyoxymethylene of Group 1, 2, or
1.4 The biocompatibility of plastic compounds made up of
3 (as described in Specification D4181), is recommended for
polyoxymethylene (acetal) resin containing colorants, fillers,
use in medical applications, however other grades of this
processing aids, or other additives as well as polymer blends
polymer may be found to be acceptable through appropriate
whichcontainpolyacetalshouldnotbeassumedonthebasisof
testing.
resin biocompatibility alone. Their biocompatibility must be
established by testing the final (end-use) compositions using
4. Physical Properties
evaluationmethodsappropriatefortheintendedapplications.It
4.1 The mechanical properties of the material shall conform
should be noted that the types, test levels and biological effects
to those listed in Specification D4181 for the appropriate grade
of extractives yielded by the additives contained in a com-
and class of polymer being evaluated. Table 1 provides typical
poundorblendmayalsohavetobeevaluatedforsomeend-use
values for both physical and mechanical properties of medical
applications.
grade polyoxymethylene (acetal) for medical applications.
1.5 The values stated in inch-pound units are to be regarded
as standard. No other units of measurement are included in this
5. Inspection and Certification
standard.
5.1 The following information shall be reported in the
1.6 This standard does not purport to address all of the
material certification: Grade and color identification (that is,
safety concerns, if any, associated with its use. It is the
color number).
responsibility of the user of this standard to establish appro-
NOTE 1—Some coloring agents have the potential to elicit an adverse
priate safety and health practices and determine the applica-
biological response, therefore any grades containing pigments, dyes, or
bility of regulatory limitations prior to use.
1 2
ThisspecificationisunderthejurisdictionofASTMCommitteeF04onMedical For referenced ASTM standards, visit the ASTM website, www.astm.org, or
and Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document
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