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BS EN ISO 10993-1:2020

Biological evaluation of medical devices

standard by British Standard / European Standard / International Organization for Standardization, 12/16/2020

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About This Item

 

Full Description

This document specifies:

— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.

All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
12/16/2020
ISBN(s):
9780580948688
Number of Pages:
50
File Size:
1 file , 1.6 MB
Same As:
ISO 10993-1:2018
Product Code(s):
30344602, 30344602, 30344602
Note:
This product is unavailable in Belarus, Russia, Ukraine
 

Document History

  1. BS EN ISO 10993-1:2020

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    Biological evaluation of medical devices

    • Most Recent

  2. BS EN ISO 10993-1:OCTOBER 2009


    Biological evaluation of medical devices

    • Historical Version

  3. BS EN ISO 10993-1:2009


    Biological evaluation of medical devices

    • Historical Version

  4. BS EN ISO 10993-1:JUNE 2009


    Biological evaluation of medical devices. Evaluation and testing

    • Historical Version

  5. BS EN ISO 10993-1 Draft


    Biological evaluation of medical devices. Evaluation and testing within a risk management process

    • Historical Version

  6. BS 06/30106186 DC


    ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management system

    • Historical Version

  7. BS EN ISO 10993-1:2003


    Biological evaluation of medical devices

    • Historical Version

  8. BS EN ISO 10993-1:1998


    Biological evaluation of medical devices. Evaluation and testing

    • Historical Version