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Status | Withdrawn - 04 Sep 2024 |
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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 |