Certificates of Conformance
PharmaTainer
The SaniSure® PharmaTainer™ PET meets the following standards
- U.S. Pharmacopeia 43, National Formulary 38 (USP), General Chapter <87>, Biological Reactivity Tests, In Vitro {2020)
- U.S. Pharmacopeia 43, National Formulary 38 (USP), General Chapter <88> Class VI, Biological Reactivity Tests, In Vivo {2020)*
- ISO 10993-5 – Part 5: Tests for in vitro Cytotoxicity (2009)
- ISO 10993-6 – Part 6: Tests for Local Effects after Implantation {2016)
- ISO 10993-10-Part 10: Tests for Irritation and Skin Sensitization (2010)
- ISO 10993-11-Part 11: Testsfor Systemic Toxicity (2017)
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