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Sterilisation von Medizinprodukten
OENORM EN ISO 10993-17
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
Edition
2024-02-15
OENORM EN ISO 10993-18/A1
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020/Amd 1:2022) (Amendment)
Edition
2024-02-15
SN EN ISO 7405
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Edition
2019-07
OEVE/OENORM EN ISO 15223-1/A1
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements - Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific (ISO 15223 1:2021/DAM 1:2024)
Edition
2024-06-15
OENORM EN ISO 10993-6
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)
Edition
2024-06-15
OENORM EN ISO 10993-2
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Edition
2023-04-01
ONR 112040
Selection of reprocessable medical devices
Edition
2012-04-01
OENORM EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition
2021-11-15
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