ASTM F2475-05
Historical Standard: ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
SUPERSEDED (see Active link, below)
ASTM F2475
1. Scope
1.1 This guide provides information to determine the appropriate testing for biocompatibility of packaging materials used to contain a medical device.
1.2 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 to determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ASTM Standards
F17 Terminology Relating to Flexible Barrier Packaging
Keywords
biocompatibility; cytotoxicity; medical device; medical device packaging; toxicity; Biocompatibility; Cytotoxicity; Medical devices/equipment; Medical/surgical packaging materials; Toxicity/toxicology ;
ICS Code
ICS Number Code 11.120.99 (Other standards related to pharmaceutics); 55.020 (Packaging and distibution of goods in general)
DOI: 10.1520/F2475-05
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