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OENORM EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
Edition
2021-05-15
OENORM EN ISO 22442-2
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
Edition
2021-05-15
OENORM 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 (ISO 22442-3:2007)
Edition
2008-04-01
OENORM EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
Edition
2023-03-01
OENORM EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)
Edition
2006-12-01
OENORM EN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices
Edition
2023-03-01
OENORM EN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Edition
2015-10-15
OENORM EN 15986
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition
2011-04-15
OEVE/OENORM EN ISO 15223-1/A1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016) (Amendment)
Edition
2019-12-01
OVE EN IEC 80001-1
Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software ((IEC 80001-1:2021) EN IEC 80001-1:2021) (german version)
Edition
2023-03-01