ASTM F665-09(2015)
(Classification)Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
SIGNIFICANCE AND USE
4.1 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.
General Information
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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:F665 −09 (Reapproved 2015)
Standard Classification for
Vinyl Chloride Plastics Used in Biomedical Application
ThisstandardisissuedunderthefixeddesignationF665;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 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 D149 Test Method for Dielectric Breakdown Voltage and
medical applications and further provides a method for speci- DielectricStrengthofSolidElectricalInsulatingMaterials
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 D150 Test Methods forAC Loss Characteristics and Permit-
long-term implants. tivity (Dielectric Constant) of Solid Electrical Insulation
D257 Test Methods for DC Resistance or Conductance of
1.2 Use is made of a classification scheme based on the
Insulating Materials
premise that the composition of vinyl chloride plastics,
D543 Practices for Evaluating the Resistance of Plastics to
copolymers, fillers, plasticizers, stabilizers, and other additives
Chemical Reagents
in these systems can be arranged into characteristic material
D570 Test Method for Water Absorption of Plastics
designations.
D792 Test Methods for Density and Specific Gravity (Rela-
1.3 In all cases where the provisions of this classification
tive Density) of Plastics by Displacement
system would conflict with those of the detailed specification
D882 Test Method for Tensile Properties of Thin Plastic
for a particular device, the latter shall take precedence.
Sheeting
NOTE 1—For cases in which the vinyl chloride plastic may be used for
D955 Test Method of Measuring Shrinkage from Mold
purposes where the requirements are too specific to be completely
Dimensions of Thermoplastics
described by this classification system, it is advisable for the purchaser to
D2124 Test Method forAnalysis of Components in Poly(Vi-
consultthesuppliertosecureadjustmentofthepropertiestosuittheactual
conditions to which the device is to be subjected.
nyl Chloride) Compounds Using an Infrared Spectropho-
tometric Technique
1.4 The biocompatibility of vinyl chloride plastics as a class
D2240 Test Method for Rubber Property—Durometer Hard-
of materials has not been established. Since many composi-
ness
tions and formulations fall under this class, it is essential that
F748 PracticeforSelectingGenericBiologicalTestMethods
the fabricators/device manufacturers assure the safety and
for Materials and Devices
efficacy of the specific composition or formulation, in its
F1251 Terminology Relating to Polymeric Biomaterials in
intended application, using state-of-the-art test methods.
Medical and Surgical Devices (Withdrawn 2012)
1.5 This classification is to assist the interface between the
2.2 Other Standards:
material supplier and the device manufacturer (fabricator) who
21 CFR Code of Federal Regulations
purchases a formulated vinyl chloride plastic for a component.
2.3 ISO Standard:
For those device manufacturers (fabricators) who do their own
ISO 10993 Biological Evaluation of Medical Devices
formulating, compounding, extrusion, molding, and so forth,
this classification does not apply.
3. Terminology
1.6 This standard does not purport to address all of the
3.1 Definitions:
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
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
bility of regulatory limitations prior to use.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
1 3
This classification is under the jurisdiction of ASTM Committee F04 on The last approved version of this historical standard is referenced on
Medical and Surgical Materials and Devicesand is the direct responsibility of www.astm.org.
Subcommittee F04.11 on Polymeric Materials. Available from Superintendent of Documents, U.S. Government Printing
Current edition approved March 1, 2015. Published May 2015. Originally Office, Washington, DC 20402.
approved in 1980. Last previous edition approved in 2009 as F665 – 09. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0665-09R15. 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
F665−09 (2015)
3.1.1 filler—a relatively inert material added to a plastic to
Letter Designation Secondary Plasticizer
modify its strength, permanence, working properties, or other
A none
qualities, or to lower costs.
B alkyl epoxy stearates
C epoxidized tall oil
3.1.2 plasticizer—a substance incorporated into a material
D epoxidized soybean oil
to increase its workability, flexibility, or distensibility.
E epoxidized linseed oil
F epoxidized sunflower oil
3.1.3 stabilizer—a substance added to a plastic that will
Z other
retard the deterioration of the plastic due to the effects of heat,
light, or oxidation.
Number Primary Plasticizer
3.1.4 vinyl chloride plastics—plastics based on polymers of
1 none
vinyl chloride or copolymers of vinyl chloride with other
2 adipic acid derivatives
monomers, the vinyl chloride being the comonomer of the 3 azelaic acid derivatives
4 benzoic acid derivatives
highest concentration by mass.
5 citric acid derivatives
6 isophthalic acid derivatives
3.2 See Terminology F1251 for additional terms relevant to
7 myristic acid derivatives
polymers.
8 phosphoric acid derivatives
9 phthalic acid derivatives
10 sebacic acid derivatives
4. Significance and Use
11 terephthalic acid derivatives
4.1 This classification was developed to permit the addition
12 polyethers
13 polyethylene glycols
of descriptive symbols and values for further new formulations
14 polyesters
with improved properties without complete reorganization of
999 other
the standard and to facilitate the incorporation of future new
5.5 Stabilizers—Stabilization systems are usually composed
test methods to keep pace with changing industry require-
of metal soap acceptors and auxiliary organic stabilizers. The
ments.
metal soap acceptors are characterized by the metal(s) present.
The following is a representative list of stabilizers. The
5. Formulation Designation
designation is obtained by using the prefix (C) followed by the
NOTE 2—No judgment is made by ASTM as to the suitability of
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 that will give guidance to the
both, by a comma.
engineer/user as to the nature of the formulation shall be used.
Letter Metal in Soap Acceptor
A general knowledge of the types of additives employed will
A none
aid in the evaluation of a particular formulation’s utility in a
B barium
medical application.
C calcium
D cadmium
5.2 Homopolymer—Bydefinition,onlyonehomopolymeris
E magnesium
covered by this classification: poly(vinyl chloride).
F lead
G strontium
5.3 Copolymer—The following is a representative list of
H
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