Horizontal Standards
EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
EN ISO 22442-2
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
EN ISO 22442-3
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 556-2
terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
EN 1422
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN ISO 11135-1
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
EN 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
EN ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose