Non-active surgical implants — General requirements
Also Known As:
SKU125466591
Published by
International Organization for Standardization
ISO
Publication Date2012-12
Pages CountPages20
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.
Details
| Edition | 4 |
| ICS Codes | 11.040.40 - Implants for surgery, prosthetics and orthotics |
| Language(s) | English |
| File Size | 194.6 KB |
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