Non-active surgical implants – General requirements (ISO 14630:2008)
Abstract
ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue.
With regard to safety, ISO 14630:2012 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
DIN EN ISO 14630:2013-03 (E)
Non-active surgical implants – General requirements (ISO 14630:2012)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………………………………. 5
2 Normative references ……………………………………………………………………………………………………………………….. 5
3 Terms and definitions ……………………………………………………………………………………………………………………….. 6
4 Intended performance ………………………………………………………………………………………………………………………. 7
5 Design attributes ………………………………………………………………………………………………………………………………. 7
6 Materials …………………………………………………………………………………………………………………………………………….. 8
7 Design evaluation ……………………………………………………………………………………………………………………………… 9
7.1 General ………………………………………………………………………………………………………………………………………………. 9
7.2 Pre-clinical evaluation ………………………………………………………………………………………………………………………. 9
7.3 Clinical evaluation …………………………………………………………………………………………………………………………….. 10
7.4 Post-market surveillance ………………………………………………………………………………………………………………….. 10
8 Manufacture ………………………………………………………………………………………………………………………………………. 10
9 Sterilization ……………………………………………………………………………………………………………………………………….. 10
9.1 General ………………………………………………………………………………………………………………………………………………. 10
9.2 Products supplied sterile …………………………………………………………………………………………………………………. 10
9.3 Sterilization by the user ……………………………………………………………………………………………………………………. 11
9.4 Sterilization residuals ……………………………………………………………………………………………………………………….. 11
10 Packaging ………………………………………………………………………………………………………………………………………….. 11
10.1 Protection from damage in storage and transport …………………………………………………………………………. 11
10.2 Maintenance of sterility in transit ……………………………………………………………………………………………………. 11
11 Information supplied by the manufacturer ……………………………………………………………………………………… 12
11.1 General ………………………………………………………………………………………………………………………………………………. 12
11.2 Labelling ……………………………………………………………………………………………………………………………………………. 12
11.3 Instructions for use …………………………………………………………………………………………………………………………… 13
11.4 Restrictions on combinations ………………………………………………………………………………………………………….. 14
11.5 Marking on implants …………………………………………………………………………………………………………………………. 14
11.6 Marking for special purposes ………………………………………………………………………………………………………….. 15
Annex Z ZA (informative) Relationship between this European Standard and the
Essential
Requirements of EU Directive 93/42/EEC