SS-EN-ISO-14630 Non-active surgical implants - General requirements (ISO 14630:2012)

SS-EN-ISO-14630 - 2012 EDITION - CURRENT
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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.

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)


Medical devices. Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

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Designation Name

SS-EN ISO 14630:2012

Revision Level

2012 EDITION

Status

Current

Publication Date

Dec. 11, 2012

Language(s)

English

Page Count

28

International Equivalent

EN ISO 14630:2012(IDT); ISO 14630:2012(IDT)