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OENORM EN ISO 10993-14
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Edition
2009-09-15
OENORM EN ISO 10993-15
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
Edition
2023-08-15
OENORM EN ISO 10993-16
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
Edition
2018-01-15
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
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
Edition
2021-02-15
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
OENORM EN ISO 10993-23
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Edition
2021-09-15
OENORM EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition
2021-11-15
OENORM 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
2021-12-01
OENORM 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
2023-09-01