ASTM F639-09

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
Significance   Top  
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 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 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

• Status: Historical
• Publication Date: 31-Jul-2009
• ICS: 11.120.01 - Pharmaceutics in general
• ICS: 83.080.20 - Thermoplastic materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaces: ASTM F639-98a(2003) - Standard Specification for Polyethylene Plastics for Medical Applications
• Effective Date: 01-Aug-2009
• Replaced By: ASTM F639-09(2015) - Standard Specification for Polyethylene Plastics for Medical Applications
• Effective Date: 01-Mar-2015
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 01-Aug-2009

Standards Content (Sample)

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:F639 −09
StandardSpecification for
1
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.
3
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
3
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:
4
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
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.
3
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
5
in polymer, in n-hexane of 5.5 % at 50°C.
1
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 Aug. 1, 2009. Published September 2009. Originally
biocompatibility of these adjuvant substances shall be estab-
approved in 1979. Last previous edition approved in 2003 as F639 – 98a(2003).
DOI: 10.1520/F0639-09.
lished on the finished compound (see Section 9).
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
4
the ASTM website. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
3
The last approved version of this historical standard is referenced on 4th Floor, New York, NY 10036, http://www.ansi.org.
5
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
1

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F639−09
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,
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately,ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F639–98a (Reapproved 2003) Designation: F 639 – 09
Standard Specification for
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. 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
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.
2. Referenced Documents
2
2.1 ASTM Standards:
D638 Test Method for Tensile Properties of Plastics
D671 Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force
D695 Test Method for Compressive Properties of Rigid Plastics
D747 Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D883 Terminology Relating to Plastics
D1238 Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
D1505 Test Method for Density of Plastics by the Density-Gradient Technique
D1898 Practice for Sampling of Plastics
−1 2
D2238Test Methods for Absorbance of Polyethylene Due to Methyl Groups at 1378 cm
D2576Test Method for Metals in Water and Waste Water by Atomic Absorption Spectrophotometry
D4976Specification for Polyethylene Plastics Molding and Extrusion Materials
3
F619Practice for Extraction of Medical Plastics
D4976 Specification for Polyethylene Plastics Molding and Extrusion Materials
0
E117 Method for Spectrographic Analysis of Pig-Lead by the Point-To-Plane Technique
7
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices Practice for Selecting Generic
Biological Test Methods for Materials and Devices
2.2 ISO Standard:
4
ISO 10993 Biological Evaluation of Medical Devices
3. Significance
3.1 This specification describes polyethylene plastics used in the manufacture of medical devices or components of medical
1
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 approved in 1979. Last previous edition approved in 1998 as F639–98a.
Current edition approved Aug. 1, 2009. Published September 2009. Originally approved in 1979. Last previous edition approved in 2003 as F639–98a(2003).
2
ForreferencedASTMstandards,visittheASTMwebsite,www.astm.org,[e-mail] AnnualBookofASTM Standards
, Vol 08.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Withdrawn.
4
Discontinued; See 1997 Annual Book of ASTM Standards , Vol 08.01.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F639–09
devices. The properties listed should be considered in selecting material according to the specific end-use requirements.
4. Classification
4.1 Types of polyethylene plastics molding and extrusion material are described in Specification D4976.
5. General Requirements
5.1 Polyethylene plastics consist of basic polymers made with ethylene as essentially the sole monomer (as defined in
Terminology D883).
5.2 Polyethylene for use in medical applications shall
...