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SN EN ISO 10993-1 : 2010 CORR 2010

Current

Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

Published date

12-01-2013

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Foreword
Introduction
1 Scope
2 Terms and definitions
3 General principles applying to biological evaluation
  of medical devices
4 Categorization of medical devices
5 Testing
6 Selection of biological evaluation tests
7 Assurance of test methods
Annex A (informative) Rationale
Annex B (informative) Flow chart to aid in ensuring a
        systematic approach to biological evaluation of
        medical devices
Bibliography

Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.

Committee
INB/NK 129
DevelopmentNote
Supersedes SN 119800. (06/2006) CORR 2010 is only available in English & French. (01/2015)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Current
Supersedes

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