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Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Draft standard

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

Standards [CURRENT]

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

Draft standard

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

Standards [CURRENT]

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

Standards [CURRENT]

OENORM EN 15986

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Edition 2011-04-15

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

Standards [CURRENT]

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

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