ASTM F639-98a

Standard Specification for Polyethylene Plastics for Medical Applications

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, etc.

General Information

• Status: Historical
• Publication Date: 09-Oct-1998
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaced By: ASTM F639-98a(2003) - Standard Specification for Polyethylene Plastics for Medical Applications
• Effective Date: 10-Apr-2003
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-Oct-1998

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 639 – 98a
Standard Specification for
Polyethylene Plastics for Medical Applications
This standard is issued under the fixed designation F 639; 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 Polyethylene Test Sheets and Test Specimens
D 2238 Test Methods for Absorbance of Polyethylene Due
1.1 This specification covers polyethylene plastics (as de-
−1
to Methyl Groups at 1378 cm
fined in Terminology D 883) intended for use in medical device
D 2576 Test Method for Metals in Water and Waste Water
applications involving human tissue contact devices, short term
by Atomic Absorption Spectrophotometry
indwellings of 30 days or less, and fluid transfer devices. The
F 619 Practice for Extraction of Medical Plastics
biocompatibility of these materials as a class has not been
F 748 Practice for Selecting Generic Biological Test Meth-
established. Biocompatibility tests must be conducted on the
ods for Materials and Devices
final product.
1.2 This specification is not applicable to ultra-high molecu-
3. Significance
lar weight polyethylenes (UHMWPE) plastics, such as those
3.1 This specification describes polyethylene plastics used
used in joint implants, etc.
in the manufacture of medical devices or components of
1.3 This standard does not purport to address all of the
medical devices. The properties listed should be considered in
safety concerns, if any, associated with its use. It is the
selecting material according to the specific end-use require-
responsibility of the user of this standard to establish appro-
ments.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Classification
2. Referenced Documents 4.1 Types of polyethylene plastics molding and extrusion
material are described in Specification D 1248.
2.1 ASTM Standards:
D 638 Test Method for Tensile Properties of Plastics
5. General Requirements
D 671 Test Method for Flexural Fatigue of Plastics by
2 5.1 Polyethylene plastics consist of basic polymers made
Constant-Amplitude-of-Force
with ethylene as essentially the sole monomer (as defined in
D 695 Test Method for Compressive Properties of Rigid
2 Terminology D 883).
Plastics
5.2 Polyethylene for use in medical applications shall have
D 747 Test Method for Apparent Bending Modulus of
2 a maximum extractable fraction, expressed as weight percent
Plastics by Means of a Cantilever Beam
in polymer, in n-hexane of 5.5 % at 50°C (1).
D 790 Test Methods for Flexural Properties of Unreinforced
5.3 The formulated compound may contain optional adju-
and Reinforced Plastics and Electrical Insulating Materi-
vant substances required in the production of the polymer or in
als
2 the fabrication or intended use of the end product. The
D 883 Terminology Relating to Plastics
biocompatibility of these adjuvant substances shall be estab-
D 1238 Test Method for Flow Rates of Thermoplastics by
2 lished on the finished compound (see Section 9).
Extrusion Plastometer
5.4 The formulated compound shall yield a consistent in-
D 1248 Specification for Polyethylene Plastics Molding and
2 frared absorption spectrum characteristic of the established
Extrusion Materials
formulation.
D 1505 Test Method for Density of Plastics by the Density-
2 5.5 Maximum levels and type of extractable metals shall be
Gradient Technique
established in accordance with the intended use of the formu-
D 1898 Practice for Sampling of Plastics
lated resin (2) (see Appendix X1).
D 1928 Practice for Preparation of Compression-Molded
NOTE 1—Appendix X1 is a suggested method for determining extract-
able metals utilizing the current state-of-the-art methodology. Alternative
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric Materials. Discontinued—See 1980 Annual Book of ASTM Standards, Part 31.
Current edition approved October 10, 1998. Published March 1999. Originally Annual Book of ASTM Standards, Vol 13.01.
published as F 639 – 79. Last previous edition F 639 – 98. The boldface numbers in parentheses refer to the list of references at the end of
Annual Book of ASTM Standards, Vol 08.01. this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 639
methods with equal reliability may be used.
8.2 The material shall be identified including lot or batch
numbers and recommended method of storage.
5.6 The physical properties of polyethylene plastics may be
determined by the methods given in Section 7.
9. Biocompatibility
6. Sampling
9.1 The biological safety of each polyethylene plastic for-
6.1 The material should be sampled in accordance with
mulation shall be established. Specific biological tests shall be
standard sampling procedures such as those described in
determined in accordance with the intended use. Formulated
Practice D 1898.
compounds used in these tests should include all colorants and
other additives present in the final product.
7. Physical Methods
9.2 Biological tests are appropriate to determine biological
7.1 The following physical test procedures are suggested
safety and tissue reaction depending on the end use application.
where applicable to the intended application:
7.1.1 Density—Test Method D 1505. These tests should be conducted when indicated for specific
7.1.2 Melt Flow—Test Method D 1238. applications. Additional tests may be necessary for certain
7.1.3 Tensile Properties—Test Method D 638.
cases; Practice F 748 and USP Class I–VI Biological Tests (3)
7.1.4 Compressive Properties—Test Method D 695.
may be used as guidelines.
7.1.5 Stiffness—Test Method D 747.
7.1.6 Flexural Fatigue—Test Method D 671.
10. Keywords
7.1.7 Flexural Properties—Test Method D 790.
10.1 plastic surgical devices/applications; polyethylene
8. Packaging and Labeling (PE) plastics—surgical implant applications; polymers—
surgical applications
8.1 The product shall be packaged in a suitable container to
prevent contamination of contents.
APPENDIXES
(Nonmandatory Information)
X1. SUGGESTED PRACTICE FOR EXTRACTABLE METALS ANALYSIS OF PLASTIC BY ATOMIC
ABSORPTION SPECTROSCOPY
X1.1 Scope compound. The total surface area of the specimen to be
exposed should be equivalent to 120 cm when the specimen
X1.1.1 This practice covers the analysis of extractable
thickness is 0.5 mm or less or 60 cm when the thickness is
metals from plastics intended for use in medical dev
...