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SN EN ISO 10993-18/A1
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process - Determination of the uncertainty factor (ISO 10993-18:2020/Amd 1:2022); Amendment A1
Edition
2023-07
SN EN ISO 10993-23
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Edition
2021-06
SN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition
2020-10
SN EN ISO 17664-1
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Edition
2021-10
SN EN ISO 17664-2
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021)
Edition
2024-01
SN EN ISO 22442-1
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
Edition
2021-04
SN 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
2021-04
SN 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
2008-03
SN EN 556-1
Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
Edition
2024-07
SN EN 556-2
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Edition
2015-11