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1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems 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.
Significance and Use:
| Author | ASTM |
|---|---|
| Editor | ASTM |
| Document type | Standard |
| Format | File |
| ICS | 11.120.99 : Other standards related to pharmaceutics
55.020 : Packaging and distribution of goods in general |
| Number of pages | 4 |
| Replace | ASTM F2475-05 |
| Set | ASTMVOL1510 |
| Year | 2011 |
| Document history | ASTM F2475-05 |
| Country | USA |
| Keyword | ASTM 2475;ASTM F2475;ASTM F2475;10.1520/F2475-11 |