ASTM F665-98(2003)
(Classification)Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
SIGNIFICANCE AND USE
This classification was developed to permit the addition of descriptive symbols and values for further new formulations with improved properties without complete reorganization of the standard and to facilitate the incorporation of future new test methods to keep pace with changing industry requirements.
SCOPE
1.1 This classification provides guidance to engineers and users in the selection of practical vinyl chloride plastics for medical applications and further provides a method for specifying these materials by use of a simple line call-out designation. This classification excludes vinyl chloride plastics used in long-term implants.
1.2 Use is made of a classification scheme based on the premise that the composition of vinyl chloride plastics, copolymers, fillers, plasticizers, stabilizers, and other additives in these systems can be arranged into characteristic material designations.
1.3 In all cases where the provisions of this classification system would conflict with those of the detailed specification for a particular device, the latter shall take precedence.
Note 1—For cases in which the vinyl chloride plastic may be used for purposes where the requirements are too specific to be completely described by this classification system, it is advisable for the purchaser to consult the supplier to secure adjustment of the properties to suit the actual conditions to which the device is to be subjected.
1.4 The biocompatibility of vinyl chloride plastics as a class of materials has not been established. Since many compositions and formulations fall under this class, it is essential that the fabricators/device manufacturers assure the safety and efficacy of the specific composition or formulation, in its intended application, using state-of-the-art test methods.
1.5 This classification is to assist the interface between the material supplier and the device manufacturer (fabricator) who purchases a formulated vinyl chloride plastic for a component. For those device manufacturers (fabricators) who do their own formulating, compounding, extrusion, molding, and so forth, this classification does not apply.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: F 665 – 98 (Reapproved 2003)
Standard Classification for
Vinyl Chloride Plastics Used in Biomedical Application
This standard is issued under the fixed designation F 665; 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 2. Referenced Documents
1.1 This classification provides guidance to engineers and 2.1 ASTM Standards:
users in the selection of practical vinyl chloride plastics for D 149 Test Method for Dielectric Breakdown Voltage and
medical applications and further provides a method for speci- Dielectric Strength of Solid Electrical Insulating Materials
fying these materials by use of a simple line call-out designa- at Commercial Power Frequencies
tion.This classification excludes vinyl chloride plastics used in D 150 Test Methods for ac Loss Characteristics and Permit-
long-term implants. tivity (Dielectric Constant) of Solid Electrical Insulating
1.2 Use is made of a classification scheme based on the Materials
premisethatthecompositionofvinylchlorideplastics,copoly- D 257 Test Methods for dc Resistance or Conductance of
mers, fillers, plasticizers, stabilizers, and other additives in Insulating Materials
these systems can be arranged into characteristic material D 543 Test Method for Resistance of Plastics to Chemical
designations. Reagents
1.3 In all cases where the provisions of this classification D 570 Test Method for Water Absorption of Plastics
system would conflict with those of the detailed specification D 792 TestMethodsforDensityandSpecificGravity(Rela-
for a particular device, the latter shall take precedence. tive Density) of Plastics by Displacement
D 882 Test Methods for Tensile Properties of Thin Plastic
NOTE 1—For cases in which the vinyl chloride plastic may be used for
Sheeting
purposes where the requirements are too specific to be completely
D 955 Test Method of Measuring Shrinkage from Mold
described by this classification system, it is advisable for the purchaser to
consultthesuppliertosecureadjustmentofthepropertiestosuittheactual Dimensions of Molded Plastics
conditions to which the device is to be subjected.
D 1898 Practice for Sampling of Plastics
D 2124 Method for Analysis of Components in Poly(Vinyl
1.4 The biocompatibility of vinyl chloride plastics as a class
Chloride) Compounds Using an Infrared Spectrophoto-
of materials has not been established. Since many composi-
metric Technique
tions and formulations fall under this class, it is essential that
D 2240 Test Method for Rubber Property—Durometer
the fabricators/device manufacturers assure the safety and
Hardness
efficacy of the specific composition or formulation, in its
F 748 PractoceforSelectingGenericBiologicalTestMeth-
intended application, using state-of-the-art test methods.
ods for Materials and Devices
1.5 This classification is to assist the interface between the
2.2 Other Standards:
material supplier and the device manufacturer (fabricator) who
Title 21 Code of Federal Regulations
purchases a formulated vinyl chloride plastic for a component.
For those device manufacturers (fabricators) who do their own
3. Terminology
formulating, compounding, extrusion, molding, and so forth,
3.1 Definitions:
this classification does not apply.
3.1.1 filler—a relatively inert material added to a plastic to
1.6 This standard does not purport to address all of the
modify its strength, permanence, working properties, or other
safety concerns, if any, associated with its use. It is the
qualities, or to lower costs.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
Annual Book of ASTM Standards, Vol 10.01.
Annual Book of ASTM Standards, Vol 08.01.
1 4
This classification is under the jurisdiction of ASTM Committee F04 on Discontinued; See 1997 Annual Book of ASTM Standards, Vol 08.01.
Medical and Surgical Materials and Devicesand is the direct responsibility of Annual Book of ASTM Standards, Vol 09.01.
Annual Book of ASTM Standards, Vol 13.01.
Subcommittee F04.11on Polymeric Materials.
Available from Superintendent of Documents, U.S. Government Printing
Current edition approved Apr. 10, 2003. Published May 2003. Originally
approved in 1980. Last previous edition approved in 1998 as F 665 – 98. Office, Washington, DC 20402.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 665 – 98 (2003)
3.1.2 plasticizer—a substance incorporated in a material to
F epoxidized sunflower oil
Z other
increase its workability, flexibility, or distensibility.
3.1.3 stabilizer—a substance added to a plastic that will
Number Primary Plasticizer
retard the deterioration of the plastic due to the effects of heat,
light, or oxidation. 1 none
2 adipic acid derivatives
3.1.4 vinyl chloride plastics—plastics based on polymers of
3 azelaic acid derivatives
vinyl chloride or copolymers of vinyl chloride with other
4 benzoic acid derivatives
monomers, the vinyl chloride being the comonomer of the 5 citric acid derivatives
6 isophthalic acid derivatives
highest concentration by mass.
7 myristic acid derivatives
8 phosphoric acid derivatives
4. Significance and Use 9 phthalic acid derivatives
10 sebacic acid derivatives
4.1 This classification was developed to permit the addition
11 terephthalic acid derivatives
12 polyethers
of descriptive symbols and values for further new formulations
13 polyethylene glycols
with improved properties without complete reorganization of
14 polyesters
the standard and to facilitate the incorporation of future new
999 other
test methods to keep pace with changing industry require-
5.5 Stabilizers—Stabilizationsystemsareusuallycomposed
ments.
of metal soap acceptors and auxiliary organic stabilizers. The
metal soap acceptors are characterized by the metal(s) present.
5. Formulation Designation
The following is a representative list of stabilizers. The
NOTE 2—No judgment is made by ASTM as to the suitability of
designation is obtained by using the prefix (C) followed by the
possible compounds classified by the following system to any specific
letter for the metal, followed by the number for the chelator
biomedical use. Knowledge of formulation composition will only aid in
used. In the event that more than one in each category is
evaluation of a composition for suitability.
present, separate multiple letter or number designations, or
5.1 A letter/number system shall be used that will give
both, by a comma.
guidance to the engineer/user as to the nature of the formula-
Letter Metal in Soap Acceptor
tion. A general knowledge of the types of additives employed
A none
will aid in the evaluation of a particular formulation’s utility in
B barium
a medical application.
C calcium
5.2 Homopolymer—By definition, only one homopolymer
D cadmium
E magnesium
is covered by this classification: poly(vinyl chloride).
F lead
5.3 Copolymer—The following is a representative list of
G strontium
major copolymers of poly(vinyl chloride). To specify the
H tin
I zinc
copolymer, use the prefix (A) followed by the number desig-
Z other
nation for the copolymer. In the event that more than one
copolymer is present, separate the individual number designa-
Number Auxiliary Organic Stabilizer
tions by a
...
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