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BS EN ISO 14971:2019

Medical devices. Application of risk management to medical devices

standard by British Standard / European Standard / International Organization for Standardization, 12/18/2019

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About This Item

 

Full Description

Valuable checklist also available to assist with compliance to this standard.

Recognized by regulatory authorities in the US, Canada, Europe and more, this international standard helps medical device manufacturers establish, document and maintain a systematic risk management process across all phases of the lifecycle of a medical device. Use of the standard helps streamline the regulatory processes that enable entry to selected markets.
 

Product Details

Published:
12/18/2019
ISBN(s):
9780539123395
Number of Pages:
46
File Size:
1 file , 2 MB
Same As:
ISO 14971:2019, ISO 14971:2019
Product Code(s):
30407615, 30407615
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. BS EN ISO 14971:2019+A11:2021


    Medical devices. Application of risk management to medical devices

    • Most Recent

  2. BS EN ISO 14971:2019

    👀currently
    viewing


    Medical devices. Application of risk management to medical devices

    • Historical Version

  3. BS EN ISO 14971:2012


    Medical devices. Application of risk management to medical devices

    • Historical Version

  4. BS EN ISO 14971:2009


    Medical devices. Application of risk management to medical devices

    • Historical Version

  5. BS EN ISO 14971:2007


    Medical devices. Application of risk management to medical devices

    • Historical Version

  6. BS 05/30140005 DC


    BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices

    • Historical Version

  7. BS EN ISO 14971:2001


    Medical devices. Application of risk management to medical devices

    • Historical Version

  8. BS EN 1441:1998


    Medical devices. Risk analysis

    • Historical Version