MDD Horizontal Standards
EN ISO 13408-3
Aseptic processing of health care products - Part 3: Lyophilization
EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 14971
Medical devices - Application of risk management to medical devices
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