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BS EN ISO 16061:2015

BS EN ISO 16061:2015

$142.49

Instrumentation for use in association with non-active surgical implants. General requirements

Published By Publication Date Number of Pages
BSI 2015 30
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PDF Catalog

PDF Pages PDF Title
4 Foreword
Endorsement notice
5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
Table ZA.1 ā€” Correspondence between this International Standard and Directive 93/42/EEC
8 Foreword
9 1 Scope
2 Normative references
10 3 Terms and definitions
4 Intended performance
5 Design attributes
11 6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
8 Manufacture
12 9 Sterilization
9.1 Products supplied sterile
9.2 Products provided non-sterile
10 Packaging
10.1 Protection from damage in storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
11.1 General
13 11.2 Labelling
14 11.3 Instructions for use
15 11.4 Instruments with measuring function
11.5 Restrictions in combinations
11.6 Marking on instruments
11.7 Instruments intended for single use
16 AnnexĀ A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture
25 Bibliography

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BS EN ISO 16061:2015
$142.49