Risk Management
EN 13641
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
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