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ASTM F639-98a(2003)

(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.
SCOPE
1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) 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 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
09-Apr-2003
ICS
11.100.99 - Other standards related to laboratory medicine
83.080.20 - Thermoplastic materials
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F639-98a - Standard Specification for Polyethylene Plastics for Medical Applications
Effective Date
10-Apr-2003
Replaced By
ASTM F639-09 - Standard Specification for Polyethylene Plastics for Medical Applications
Effective Date
01-Aug-2009
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
10-Apr-2003

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ASTM F639-98a(2003) - Standard Specification for Polyethylene Plastics for Medical ApplicationsASTM F639-98a(2003) - Standard Specification for Polyethylene Plastics for Medical Applications
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ASTM F639-98a(2003) - Standard Specification for Polyethylene Plastics for Medical Applications
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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: F 639 – 98a (Reapproved 2003)
Standard Specification for
Polyethylene Plastics for Medical Applications
This standard is issued under the fixed designation F639; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope D2238 Test Methods for Absorbance of Polyethylene Due
−1
to Methyl Groups at 1378 cm
1.1 This specification covers polyethylene plastics (as de-
D2576 Test Method for Metals in Water and Waste Water
finedinTerminologyD883)intendedforuseinmedicaldevice
by Atomic Absorption Spectrophotometry
applicationsinvolvinghumantissuecontactdevices,shortterm
D4976 SpecificationforPolyethylenePlasticsMoldingand
indwellings of 30 days or less, and fluid transfer devices. The
Extrusion Materials
biocompatibility of these materials as a class has not been
F619 Practice for Extraction of Medical Plastics
established. Biocompatibility tests must be conducted on the
F748 Practice for Selecting Generic Biological Test Meth-
final product.
ods for Materials and Devices
1.2 Thisspecificationisnotapplicabletoultra-highmolecu-
lar weight polyethylenes (UHMWPE) plastics, such as those
3. Significance
used in joint implants, and so forth.
3.1 This specification describes polyethylene plastics used
1.3 This standard does not purport to address all of the
in the manufacture of medical devices or components of
safety concerns, if any, associated with its use. It is the
medical devices. The properties listed should be considered in
responsibility of the user of this standard to establish appro-
selecting material according to the specific end-use require-
priate safety and health practices and determine the applica-
ments.
bility of regulatory limitations prior to use.
4. Classification
2. Referenced Documents
4.1 Types of polyethylene plastics molding and extrusion
2.1 ASTM Standards:
2 material are described in Specification D4976.
D638 Test Method for Tensile Properties of Plastics
D671 Test Method for Flexural Fatigue of Plastics by
5. General Requirements
Constant-Amplitude-of-Force
5.1 Polyethylene plastics consist of basic polymers made
D695 Test Method for Compressive Properties of Rigid
with ethylene as essentially the sole monomer (as defined in
Plastics
Terminology D883).
D747 Test Method for Apparent Bending Modulus of
5.2 Polyethylene for use in medical applications shall have
Plastics by Means of a Cantilever Beam
a maximum extractable fraction, expressed as weight percent
D790 TestMethodsforFlexuralPropertiesofUnreinforced
in polymer, in n-hexane of 5.5% at 50°C (1).
and Reinforced Plastics and Electrical Insulating Materi-
2 5.3 The formulated compound may contain optional adju-
als
vantsubstancesrequiredintheproductionofthepolymerorin
D883 Terminology Relating to Plastics
the fabrication or intended use of the end product. The
D1238 Test Method for Flow Rates of Thermoplastics by
biocompatibility of these adjuvant substances shall be estab-
Extrusion Plastometer
lished on the finished compound (see Section 9).
D1505 Test Method for Density of Plastics by the Density-
2 5.4 The formulated compound shall yield a consistent in-
Gradient Technique
4 frared absorption spectrum characteristic of the established
D1898 Practice for Sampling of Plastics
formulation.
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.
Current edition approved Apr. 10, 2003. Published May 2003. Originally Discontinued—See 1980 Annual Book of ASTM Standards, Part 31.
approved in 1979. Last previous edition approved in 1998 as F639–98a. Annual Book of ASTM Standards, Vol 08.03.
2 7
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 13.01.
3 8
Discontinued; See 2001 Annual Book of ASTM Standards, Vol 08.01. Theboldfacenumbersinparenthesesrefertothelistofreferencesattheendof
Discontinued; See 1997 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.
F 639 – 98a (2003)
5.5 Maximum levels and type of extractable metals shall be 8. Packaging and Labeling
established in accordance with the intended use of the formu-
8.1 The product shall be packaged in a suitable container to
lated resin (2) (see Appendix X1).
prevent contamination of contents.
NOTE 1—Appendix X1 is a suggested method for determining extract- 8.2 The material shall be identified including lot or batch
able metals utilizing the current state-of-the-art methodology.Alternative
numbers and recommended method of storage.
methods with equal reliability may be used.
5.6 The physical properties of polyethylene plastics may be 9. Biocompatibility
determined by the methods given in Section 7.
9.1 The biological safety of each polyethylene plastic for-
mulation shall be established. Specific biological tests shall be
6. Sampling
determined in accordance with the intended use. Formulated
6.1 The material should be sampled in accordance with
compounds used in these tests should include all colorants and
standard sampling procedures such as those described in
other additives present in the final product.
Practice D1898.
9.2 Biological tests are appropriate to determine biological
safetyandtissuereactiondependingontheenduseapplication.
7. Physical Methods
These tests should be conducted when indicated for specific
7.1 The following physical test procedures are suggested
applications. Additional tests may be necessary for certain
where applicable to the intended application:
cases; Practice F748 and USPClass I–VI Biological Tests (3)
7.1.1 Density—Test Method D1505.
may be used as guidelines.
7.1.2 Melt Flow—Test Method D1238.
7.1.3 Tensile Properties—Test Method D638.
10. Keywords
7.1.4 Compressive Properties—Test Method D695.
7.1.5 Stiffness—Test Method D747. 10.1 plastic surgical devices/applications; polyethylene
7.1.6 Flexural Fatigue—Test Method D671. (PE) plastics—surgical implant applications; polymers—
7.1.7 Flexural Properties—Test Method D790. surgical applications
APPENDIXES
(Nonmandatory Information)
X1. SUGGESTED PRACTICE FOR EXTRACTABLE METALS ANALYSIS OF PLASTIC BYATOMIC
ABSORPTION SPECTROSCOPY
X1.1 Scope extracts is based on the surface area of the plastic extracted
fromwhichthetotalamountofmetaldeliverabletothepatient
X1.1.1 This practice covers the analysis of extra
...

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