ISO 14630:2012

Non-active surgical implants — General requirements

OVERVIEW

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.

COMMENTS

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PRODUCT DETAILS

Status Withdrawn - 04 Sep 2024
Edition 2012
No. of Pages 13
ICS Classification 11.040.40 Implants for surgery, prosthetics and orthotics
Committee ISO/TC 150
Available for Purchase For sale in Singapore only
Adoption ISO