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  • BSI
    BS EN ISO 10993-1:October 2009 Biological evaluation of medical devices - Evaluation and testing within a risk management process
    Edition: 2017
    $418.55
    / user per year

Description of BS EN ISO 10993-1:October 2009 2017

This part of ISO 10993 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;

  • the general categorization of 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.

This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.



Standard NumberBS EN ISO 10993-1:October 2009
TitleBiological evaluation of medical devices - Evaluation and testing within a risk management process
StatusWithdrawn
Publication Date2017-01-31
Withdrawn Date2020-12-16
ReplacesBS EN ISO 10993-1:June 2009
Replaced ByBS EN ISO 10993-1:2020
CorrectsBS EN ISO 10993-1:October 2009
DescriptorsCytotoxicity tests, Bioassay, Clinical investigation instruments, Dental materials, Medical equipment, Compatibility, Implants (surgical), Biological hazards, Biological analysis and testing, Medical instruments, Dental equipment, Contaminants, Medical technology
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 580 97500 4
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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