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Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

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

Standards [CURRENT]

OENORM EN ISO 10993-23

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
Edition 2021-09-15

Standards [CURRENT]

OENORM EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
Edition 2021-11-15

Standards [CURRENT]

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

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

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