ASTM F639-09(2015)
(Specification)Standard Specification for Polyethylene Plastics for Medical Applications
Standard Specification for Polyethylene Plastics for Medical Applications
ABSTRACT
This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.
SIGNIFICANCE AND USE
X1.2 Significance
X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.
SCOPE
1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.
1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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
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: F639 −09 (Reapproved 2015)
Standard Specification for
Polyethylene Plastics for Medical Applications
ThisstandardisissuedunderthefixeddesignationF639;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D883 Terminology Relating to Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics
1.1 This specification covers polyethylene plastics (as de-
by Extrusion Plastometer
fined inTerminology D883) intended for use in medical device
D1505 Test Method for Density of Plastics by the Density-
applications involving human tissue contact devices, short-
Gradient Technique
term indwellings of 30 days or less, and fluid transfer devices.
D1898 Practice for Sampling of Plastics (Withdrawn 1998)
The biocompatibility of these materials as a class has not been
D4976 Specification for Polyethylene Plastics Molding and
established. Biocompatibility tests must be conducted on the
Extrusion Materials
final product.
E117 MethodforSpectrographicAnalysisofPigLeadbythe
1.2 Thisspecificationisnotapplicabletoultra-highmolecu-
Point-to-Plane Technique (Withdrawn 1995)
lar weight polyethylenes (UHMWPE) plastics, such as those
F748 PracticeforSelectingGenericBiologicalTestMethods
used in joint implants, and so forth.
for Materials and Devices
1.3 The values stated in SI units are to be regarded as
2.2 ISO Standard:
standard. No other units of measurement are included in this
ISO 10993 Biological Evaluation of Medical Devices
standard.
3. Significance
1.4 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3.1 This specification describes polyethylene plastics used
responsibility of the user of this standard to establish appro-
in the manufacture of medical devices or components of
priate safety and health practices and determine the applica-
medical devices. The properties listed should be considered in
bility of regulatory limitations prior to use.
selecting material according to the specific end-use require-
ments.
2. Referenced Documents
2.1 ASTM Standards:
4. Classification
D638 Test Method for Tensile Properties of Plastics
4.1 Types of polyethylene plastics molding and extrusion
D671 Test Method for Flexural Fatigue of Plastics by
material are described in Specification D4976.
Constant-Amplitude-of-Force (Withdrawn 2002)
D695 Test Method for Compressive Properties of Rigid
5. General Requirements
Plastics
5.1 Polyethylene plastics consist of basic polymers made
D747 Test Method for Apparent Bending Modulus of Plas-
with ethylene as essentially the sole monomer (as defined in
tics by Means of a Cantilever Beam
Terminology D883).
D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materi- 5.2 Polyethylene for use in medical applications shall have
als
a maximum extractable fraction, expressed as weight percent
in polymer, in n-hexane of 5.5 % at 50°C.
This specification is under the jurisdiction of ASTM Committee F04 on
5.3 The formulated compound may contain optional adju-
Medical and Surgical Materials and Devices and is the direct responsibility of
vant substances required in the production of the polymer or in
Subcommittee F04.11 on Polymeric Materials.
the fabrication or intended use of the end product. The
Current edition approved March 1, 2015. Published May 2015. Originally
biocompatibility of these adjuvant substances shall be estab-
approved in 1979. Last previous edition approved in 2009 as F639 – 09. DOI:
10.1520/F0639-09R15.
lished on the finished compound (see Section 9).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
The last approved version of this historical standard is referenced on 4th Floor, New York, NY 10036, http://www.ansi.org.
www.astm.org. Federal Register, Vol 21, Part 177.1520.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F639 − 09 (2015)
5.4 The formulated compound shall yield a consistent in- 8. Packaging and Labeling
frared absorption spectrum characteristic of the established
8.1 The product shall be packaged in a suitable container to
formulation.
prevent contamination of contents.
5.5 Maximum levels and type of extractable metals shall be
8.2 The material shall be identified, including lot or batch
established in accordance with the intended use of the formu-
numbers and recommended method of storage.
lated resin (see Appendix X1).
9. Biocompatibility
NOTE 1—Appendix X1 is a suggested method for determining extract-
9.1 The biological safety of each polyethylene plastic for-
able metals utilizing the current state-of-the-art methodology. Alternative
mulation shall be established. Specific biological tests shall be
methods with equal reliability may be used.
determined in accordance with the intended use. Formulated
5.6 The physical properties of polyethylene plastics may be
compounds used in these tests should include all colorants and
determined by the methods given in Section 7.
other additives present in the final product.
6. Sampling
9.2 Biological tests are appropriate to determine biological
safety and tissue reaction, depending on the end use applica-
6.1 The material should be sampled in accordance with
tion. These tests should be conducted when indicated for
standard sampling procedures such as those described in
specific applications. Additional tests may be necessary for
Practice D1898.
certain cases; Practice F748 and ISO 10993 may be used as
7. Physical Methods guidelines.
9.2.1 Biocompatibility testing should be performed on
7.1 The following physical test procedures are suggested
specimens that have been processed and sterilized using the
where applicable to the intended application:
methods intended for the final device. It should be noted that
7.1.1 Density—Test Method D1505.
radiation sterilization of the polyethylene has been shown to
7.1.2 Melt Flow—Test Method D1238.
cause adverse effects on the properties of the material, such as
7.1.3 Tensile Properties—Test Method D638.
chain scission and the creation of free radicals that lead to
7.1.4 Compressive Properties—Test Method D695.
oxidation and subsequent deterioration of mechanical proper-
7.1.5 Stiffness—Test Method D747.
ties.
7.1.6 Flexural Fatigue—Test Method D
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