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ASTM F 665 : 2009 : R2015

Current
Current

The latest, up-to-date edition.

Standard Classification for Vinyl Chloride Plastics Used in Biomedical Application
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-01-2015

CONTAINED IN VOL. 13.01, 2015 Specifies 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.

1.1This 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.

1.2Use 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.

1.3In 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.

1.4The 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.

1.5This 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.

1.6This 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.

Committee
F 04
DocumentType
Standard
Pages
4
ProductNote
Reconfirmed 2015
PublisherName
American Society for Testing and Materials
Status
Current

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM D 2240 : 2000 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2124 : 1999 : R2011 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique (Withdrawn 2020)
ASTM D 150 : 2022 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
ASTM D 955 : 2008 : R2014 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
ASTM D 257 : 2014 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D 2240 : 2004 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 543 : 2014 : REDLINE Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM D 543 : 2021 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM D 2240 : 2004 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2015 : R2021 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2002 Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 543 : 2020 Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents
ASTM D 2240 : 2015 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2003 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2002 : REV B Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 955 : 2021 Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics
ASTM D 257 : 2014 : REDLINE Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D 570 : 2022 Standard Test Method for Water Absorption of Plastics
ASTM D 2240 : 2015 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2124 : 1999 : EDT 1 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique
ASTM D 2240 : 2005 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 150 : 2018 Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
ASTM D 2240 : 2005 : R2010 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
ASTM D 2240 : 2002 : REV A Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 257 : 2014 : R2021 : EDT 1 Standard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)
ASTM D 2124 : 1999 : R2004 Standard Test Method for Analysis of Components in Poly(Vinyl Chloride) Compounds Using an Infrared Spectrophotometric Technique

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