ASTM F1830 Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps*, 2017-09-01 Update
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*, 2018-08-01 Update
ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood*, 2017-04-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*, 2023-12-23 Update
ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment 2: Revision to 4.3.4*, 2018-11-08 Update
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11658 Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
BS ISO 18242:2016 history
2023BS ISO 18242:2016+A1:2023 Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps
2016BS ISO 18242:2016 Cardiovascular implants and extracorporeal systems. Centrifugal blood pumps