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BSI 22/30399894 DC 2022

BSI 22/30399894 DC 2022

$13.70

BS EN ISO 14630. Non-active surgical implants. General requirements

Published By Publication Date Number of Pages
BSI 2022 35
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PDF Catalog

PDF Pages PDF Title
1 30399894-NC.pdf
3 ISO_DIS 14630 ed.5 – id.76810 Enquiry PDF (en).pdf
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
14 4 Intended performance
5 Design attributes
16 6 Selection of materials
7 Design evaluation
7.1 General
17 7.2 Pre-clinical evaluation
18 7.3 Clinical evaluation and clinical investigation
19 7.4 Post-market surveillance
8 Manufacture
20 9 Sterilization
9.1 Implants supplied sterile
9.2 Implants supplied non-sterile
9.3 Implants that are resterilizable
21 9.4 Sterilization residuals
10 Packaging
10.1 Protection from damage in transport, storage and handling
10.2 Maintenance of sterility in transport, storage and handling
11 Information supplied by the manufacturer
11.1 General
22 11.2 Marking on implants
11.3 Label
24 11.4 Instructions for use
26 11.5 Patient record label(s)
11.6 Implant card
27 11.7 Implants for special purposes
28 Annex€ZA (informative) Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
33 Bibliography

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BSI 22/30399894 DC 2022
$13.70