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  • BSI
    BS EN ISO 10993-1:June 2009 Biological evaluation of medical devices - Evaluation and testing
    Edition: 2010
    $435.35
    / user per year

Description of BS EN ISO 10993-1:June 2009 2010

This part of ISO 10993 describes

  1. the general principles governing the biological evaluation of medical devices;

  2. the categorization of devices based on the nature and duration of their contact with the body;

  3. the selection of appropriate tests.

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.

NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).



Standard NumberBS EN ISO 10993-1:June 2009
TitleBiological evaluation of medical devices - Evaluation and testing
StatusWithdrawn
Publication Date2010-04-30
Withdrawn Date2010-06-30
Replaced ByBS EN ISO 10993-1:October 2009
Identical National Standard OfISO 10993-1:2003, EN ISO 10993-1:2009
CorrectsBS EN ISO 10993-1:2009
DescriptorsImplants (surgical), Medical technology, Cytotoxicity tests, Dental equipment, Clinical investigation instruments, Biological analysis and testing, Medical instruments, Biological hazards, Medical equipment, Dental materials, Bioassay, Compatibility, Contaminants
ICS11.100.20 Biological evaluation of medical devices
CommitteeCH/194
ISBN978 0 580 70924 1
PublisherBSI
Pages26

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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