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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/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]

SN EN ISO 7405

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12)
Edition 2019-07

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

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO/DIS 10993-6:2024)
Edition 2024-06-15

Standards [CURRENT]

OENORM EN ISO 10993-2

Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
Edition 2023-04-01

Technical rule [CURRENT]

ONR 112040

Selection of reprocessable medical devices
Edition 2012-04-01

Standards [CURRENT]

OENORM EN ISO 14155

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

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

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