ASTM F1855-00(2005)
(Specification)Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
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 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.
1.5 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.
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Designation: F1855 – 00 (Reapproved 2005)
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 priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
1.1 This specification covers polyoxymethylene (acetal)
resin for medical applications. This specification provides
2. Referenced Documents
requirements and associated test methods for a form of this
2.1 ASTM Standards:
thermoplastic which is intended for use in manufacturing
D4181 Classification forAcetal (POM) Molding and Extru-
medical devices, instrumentation or components thereof.
sion Materials
1.2 As will any material, some characteristics may be
D883 Terminology Relating to Plastics
altered by the processing techniques (such as molding, extru-
D1600 Terminology for Abbreviated Terms Relating to
sion, machining, sterilization, and so forth) required for a
Plastics
specific application. Therefore properties of fabricated forms
F748 Practice for Selecting Generic Biological Test Meth-
ofthisresinshouldbeevaluatedusingappropriatetestmethods
ods for Materials and Devices
to assure safety and efficacy.
1.3 Although this resin has been used and for specific
3. Chemical Composition
implant applications in the United States, the use of this resin
3.1 The chemical composition of the material shall conform
in medical devices should be restricted to non-implant appli-
to Specification D4181. The FTIR spectrum of the material
cations until biocompatibility evaluations appropriate for the
must be consistent with a reference or standard piece of the
intended applications are successfully completed.
appropriate grade of the polymer. It may be helpful for the
1.4 The biocompatibility of plastic compounds made up of
reader to review Terminology D883 and Terminology D1600
polyoxymethylene (acetal) resin containing colorants, fillers,
for clarification of terminology.
processing aids, or other additives as well as polymer blends
3.2 Class 1, Grade 1 of polyoxymethylene of Group 1, 2, or
whichcontainpolyacetalshouldnotbeassumedonthebasisof
3 (as described in Specification D4181), is recommended for
resin biocompatibility alone. Their biocompatibility must be
use in medical applications, however other grades of this
established by testing the final (end-use) compositions using
polymer may be found to be acceptable through appropriate
evaluationmethodsappropriatefortheintendedapplications.It
testing.
should be noted that the types, test levels and biological effects
of extractives yielded by the additives contained in a com-
4. Physical Properties
poundorblendmayalsohavetobeevaluatedforsomeend-use
4.1 The mechanical properties of the material shall conform
applications.
to those listed in Specification D4181 for the appropriate grade
1.5 This standard does not purport to address all of the
and class of polymer being evaluated. Table 1 provides typical
safety concerns, if any, associated with its use. It is the
values for both physical and mechanical properties of medical
responsibility of the user of this standard to establish appro-
grade polyoxymethylene (acetal) for medical applications.
1 2
This specification is under the jurisdiction of ASTM Committee F04 on For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Medical and Surgical Materials and Devices and is the direct responsibility of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Subcommittee F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Mar. 1, 2005. Published March 2005. Originally the ASTM website.
approved in 1998. Last previous edition approved in 2000 as F1855 – 00. DOI: Withdrawn. The last approved version of this historical standard is referenced
10.1520/F1855-00R05. on www.astm.org.
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