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Standards [CURRENT]

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
Edition 2022-04

Standards [CURRENT]

CSA ISO 14971

Medical devices - Application of risk management to medical devices (Adopted ISO 14971:2019, third edition, 2019-12)
Edition 2021-08-01

Draft standard

DIN EN ISO 21762

Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025); German and English version prEN ISO 21762:2025
Edition 2025-10

Standards [CURRENT]

DIN EN 13060

Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing; German version EN 13060:2025
Edition 2025-10

Standards [CURRENT]

DIN EN ISO 22442-1

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020
Edition 2021-08

Draft standard

DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024
Edition 2024-07

Standards [CURRENT]

CSA ISO/TR 24971

Medical devices - Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)
Edition 2021-08-01

Technical rule [CURRENT]

VDI 5700 Blatt 1

Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
Edition 2022-01

Standards [CURRENT]

CSA Z18777

Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements
Edition 2008-02-01

Standards [CURRENT]

CSA IEC 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices (Adopted IEC 62366-1:2015, edition 1:2015 consolidated with amendment 1:2020)
Edition 2022

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