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NEN EN ISO 10993-1 : 2009 C1 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

01-12-2013

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

Explains the general principles governing the biological evaluation of medical devices within a risk management process.

DevelopmentNote
Supersedes NEN ISO 10993-1. (09/2002)
DocumentType
Standard
PublisherName
Netherlands Standards
Status
Current
Supersedes

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