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ASTM F665-09

(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.

General Information

Status
Historical
Publication Date
31-Jul-2009
ICS
07.100.10 - Medical microbiology
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.11 - Polymeric Materials
Current Stage
Ref Project

Relations

Replaces
ASTM F665-98(2003) - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
Effective Date
01-Aug-2009
Replaced By
ASTM F665-09(2015) - Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
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

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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:F665 −09
StandardClassification for
1
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
2
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.
3
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
4
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
5
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-
2
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.
4
Subcommittee F04.11 on Polymeric Materials. Available from Superintendent of Documents, U.S. Government Printing
Current edition approved Aug. 1, 2009. Published September 2009. Originally Office, Washington, DC 20402.
5
approvedin1980.Lastpreviouseditionapprovedin2003asF665 – 98(2003).DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F0665-09. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocke
...

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:F665–98 (Reapproved 2003) Designation: F 665 – 09
Standard Classification for
1
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 (´) indicates an editorial change since the last revision or reapproval.
1. 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D 149 Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at
Commercial Power Frequencies
D 150 Test Methods for acAC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulating
2
Materials Insulation
D 257 Test Methods for dcDC Resistance or Conductance of Insulating Materials
D 543 Test Method Practices for Evaluating the Resistance of Plastics to Chemical Reagents
D 570 Test Method for Water Absorption of Plastics
D 792 Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
3
D 882 Test Methods for Tensile Properties of Thin Plastic Sheeting
3
D955Test Method of Measuring Shrinkage from Mold Dimensions of Molded Plastics
D1898Practice for Sampling of Plastics Test Method for Tensile Properties of Thin Plastic Sheeting
D 955 Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
D 2124 Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric
Technique
D 2240 Test Method for Rubber Property—Durometer Hardness
F 748 Practoce for Selecting Generic Biological Test Methods for Materials and Devices Practice for Selecting Generic
1
This classification 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 1980. Last previous edition approved in 1998 as F665–98.
Current edition approved Aug. 1, 2009. Published September 2009. Originally approved in 1980. Last previous edition approved in 2003 as F 665 – 98(2003).
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
, Vol 10.01.
...

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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.  
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This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, and UNS R30556 nickel alloy billets and bars for reforging. The products shall be hot worked from ingots by rolling, forging, extruding, hammering, or pressing. The material shall conform to the chemical composition requirements prescribed by the reference material. The chemical composition of the material shall be determined by chemical analysis in accordance with test method E1473.
SCOPE
1.1 This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N10362, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, UNS N06699, and UNS R305562 billets and bars for reforging.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
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 become familiar with all hazards including those identified in the appropriate Safety Data Sheet (SDS) for this product/material as provided by the manufacturer, to establish appropriate safety, health, and environmental practices, and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Technical specification
    5 pages
    English language
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  • Technical specification
    5 pages
    English language
    sale 15% off