ASTM-F997 2010

$35.75

F997-10 Standard Specification for Polycarbonate Resin for Medical Applications

Published By	Publication Date	Number of Pages
ASTM	2010	3

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Categories: 11.100.99 - Other standards related to laboratory medicine, 11.120.01 - Pharmaceutics in general, 83.080.20 - Thermoplastic materials, ASTM

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Description

1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices.

1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.

1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.

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.

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PDF Pages	PDF Title
1	Scope Referenced Documents Significance and Use
2	Classification General Requirements Physical Properties Biocompatibility Sampling Packaging and Labeling Keywords X1. RATIONALE X1.1
3	X2. BIOCOMPATIBILITY X2.1

Additional information

Standard Title	F997-10 Standard Specification for Polycarbonate Resin for Medical Applications
Published Code	ASTM
Publication Date	2010
Pages Count	3
ICS Codes	11.100.99 - Other standards related to laboratory medicine 11.120.01 - Pharmaceutics in general 83.080.20 - Thermoplastic materials

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ASTM-F997 2010

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