ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
GOST R ISO 7199-2010 history
2010GOST R ISO 7199-2010 Blood-gas exchangers (oxygenators). Technical requirements and test methods