11.040.01 : Medical equipment in general

NF C01-891 (02/1999)

NF C01-891 (02/1999)

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Vocabulaire électrotechnique - Chapitre 891 : électrobiologie.

€131.33

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NBN ISO 16142-1:2021

NBN ISO 16142-1:2021

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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

€50.00

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NBN ISO 16142-2:2021

NBN ISO 16142-2:2021

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Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

€50.00

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NBN ISO 20069:2021

NBN ISO 20069:2021

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Guidance for assessment and evaluation of changes to drug delivery systems

€163.00

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CR 13217:1998

CR 13217:1998

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Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale

€50.00

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NBN EN ISO 10993-7:1996

NBN EN ISO 10993-7:1996

Superseded Historical

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:1995)

€50.00

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ISO/TR 19244:2014

ISO/TR 19244:2014

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Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

€51.00

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ISO 20069:2019 (R2024)

ISO 20069:2019 (R2024)

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Guidance for assessment and evaluation of changes to drug delivery systems

€208.00

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ISO/TR 20416:2020

ISO/TR 20416:2020

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Medical devices — Post-market surveillance for manufacturers

€225.00

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ISO 20417:2021

ISO 20417:2021

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Medical devices — Information to be supplied by the manufacturer

€259.00

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ISO 14971:2019 (R2025)

ISO 14971:2019 (R2025)

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Medical devices — Application of risk management to medical devices

€225.00

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ISO/TR 24971:2020

ISO/TR 24971:2020

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Medical devices — Guidance on the application of ISO 14971

€261.00

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ISO/TR 24971:2013

ISO/TR 24971:2013

Superseded Historical

Medical devices — Guidance on the application of ISO 14971

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ISO 13485:2016 (R2025)

ISO 13485:2016 (R2025)

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Medical devices — Quality management systems — Requirements for regulatory purposes

€225.00

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UNE-EN ISO 16571:2024

UNE-EN ISO 16571:2024

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Systems for evacuation of plume generated by medical devices (ISO 16571:2024)

€101.00

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