ASTM F2475-20
Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
| Standard number: | ASTM F2475-20 |
| Released: | 01.01.2020 |
| Status: | Active |
| Pages: | 3 |
| Section: | 15.10 |
| Keywords: | biocompatibility; cytotoxicity; medical device; medical device packaging; toxicity; |
| ASTM number: | ASTM F2475 |
| Supersedes: | F2475-11 |
1.1 This guide provides information to determine the appropriate testing for biocompatibility of medical device packaging materials that have the potential to contact the patient directly or indirectly.
1.2 This guide does not apply to secondary or tertiary packaging materials.
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 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.
Clinical investigation of medical devices for human subjects. Good clinical practice
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices