Standard | Standard Title | Test method(s) |
---|---|---|
ISO 10993-4 | ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood | Complement Activation |
ISO 10993-4 and ASTM F756 | ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials | Direct and Indirect Hemolysis |
ISO 10993-5 | ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | MEM Elution Cytotoxicity |
ISO 10993-10 | ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | Dermal Irritation, Intracutaneous Reactivity Irritation, Guinea Pig Maximization Sensitization, and Closed Patch Sensitization |
ISO 10993-11 | ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | Acute Systemic Toxicity |
ISO 10993-11 and USP 151 | ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity USP <151>: Pyrogen Test | Material-Mediated Pyrogenicity |
ISO 10993-12 | ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials | Sample preparation for all test types |
Standard | Standard Title | Test method(s) |
---|---|---|
ANSI/AAMI 60601-1 | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the IEC/ISO 60601/80601 family) | |
IEC 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards in the IEC 61010 family) |