ASTM F1855-00(2019)
(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 thereof.
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 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 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 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.
1.8 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.
General Information
Relations
Standards Content (Sample)
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.
Designation:F1855 −00 (Reapproved 2019)
Standard Specification for
1
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 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This specification covers polyoxymethylene (acetal)
responsibility of the user of this standard to establish appro-
resin for medical applications. This specification provides
priate safety and health practices and determine the applica-
requirements and associated test methods for a form of this
bility of regulatory limitations prior to use.
thermoplastic which is intended for use in manufacturing
1.8 This international standard was developed in accor-
medical devices, instrumentation or components thereof.
dance with internationally recognized principles on standard-
1.2 As with any material, some characteristics may be
ization established in the Decision on Principles for the
altered by the processing techniques (such as molding,
Development of International Standards, Guides and Recom-
extrusion, machining, sterilization, and so forth) required for a
mendations issued by the World Trade Organization Technical
specific application. Therefore properties of fabricated forms
Barriers to Trade (TBT) Committee.
ofthisresinshouldbeevaluatedusingappropriatetestmethods
to assure safety and efficacy.
2. Referenced Documents
2
1.3 Although this resin has been used for specific implant
2.1 ASTM Standards:
applications in the United States, the use of this resin in
D570 Test Method for Water Absorption of Plastics
medical devices should be restricted to non-implant applica-
D638 Test Method for Tensile Properties of Plastics
tions until biocompatibility evaluations appropriate for the
D695 Test Method for Compressive Properties of Rigid
intended applications are successfully completed.
Plastics
D732 Test Method for Shear Strength of Plastics by Punch
1.4 The biocompatibility of plastic compounds made up of
Tool
polyoxymethylene (acetal) resin containing colorants, fillers,
D792 Test Methods for Density and Specific Gravity (Rela-
processing aids, or other additives as well as polymer blends
tive Density) of Plastics by Displacement
whichcontainpolyacetalshouldnotbeassumedonthebasisof
D883 Terminology Relating to Plastics
resin biocompatibility alone. Their biocompatibility must be
D1600 Terminology forAbbreviatedTerms Relating to Plas-
established by testing the final (end-use) compositions using
tics
evaluationmethodsappropriatefortheintendedapplications.It
D1822 Test Method for Tensile-Impact Energy to Break
shouldbenotedthatthetypes,testlevels,andbiologicaleffects
Plastics and Electrical Insulating Materials
of extractives yielded by the additives contained in a com-
D4181 Classification for Acetal (POM) Molding and Extru-
poundorblendmayalsohavetobeevaluatedforsomeend-use
3
sion Materials (Withdrawn 2005)
applications.
F748 PracticeforSelectingGenericBiologicalTestMethods
1.5 The values stated in inch-pound units are to be regarded
for Materials and Devices
as standard. No other units of measurement are included in this
standard.
3. Chemical Composition
1.6 This standard does not purport to address all of the
3.1 The chemical composition of the material shall conform
safety concerns, if any, associated with its use. It is the
to Classification D4181. The FTIR spectrum of the material
responsibility of the user of this standard to establish appro-
must be consistent with a reference or standard piece of the
priate safety, health, and environmental practices and deter-
appropriate grade of the polymer. It may be helpful for the
mine the applicability 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 service@astm.org. For Annual Book of ASTM
F04.11 on Polymeric Materials. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2019. Published December 2019. Originally the ASTM website.
3
approved in 1998. Last previous edition approved in 2011 as F1855–00(2011). DOI: The last approved version of this historical s
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.