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BS EN ISO 16061:2015 – TC:2020 Edition

BS EN ISO 16061:2015 – TC:2020 Edition

$186.33

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

Published By Publication Date Number of Pages
BSI 2020 66
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PDF Catalog

PDF Pages PDF Title
40 Foreword
Endorsement notice
41 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
44 Foreword
45 1 Scope
2 Normative references
46 3 Terms and definitions
4 Intended performance
5 Design attributes
47 6 Selection of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.3 Clinical evaluation
8 Manufacture
48 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
49 11.2 Labelling
50 11.3 Instructions for use
51 11.4 Instruments with measuring function
11.5 Restrictions in combinations
11.6 Marking on instruments
11.7 Instruments intended for single use
52 Annex A (informative) Examples of typical instrument applications, together with materials found acceptable for instrument manufacture
61 Bibliography

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BS EN ISO 16061:2015 - TC
$186.33