ISO 16142-2-2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection o

ISO 16142-1-2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non?IVD medical devices and guidance on the selecti ISO 15882-2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results ISO 15676-2016 Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) ISO 17664-2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices 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 ISO 18241-2016 Cardiovascular implants and extracorporeal systems - Cardiopulmonary bypass systems - Venous bubble traps