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ISO 16061 : 2015

M00022343

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ISO 16061 : 2015

INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS

International Organization for Standardization

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Table of Contents

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Selection of materials
7 Design evaluation
8 Manufacture
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (informative) - Examples of typical
         instrument applications, together with
         materials found acceptable for instrument
         manufacture
Bibliography

Abstract

Defines general requirements for instruments to be used in association with non-active surgical implants.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 150
Supersedes
  • ISO 16061 : 2008
  • ISO/DIS 16061 : 60.00 (2015)