DS/EN ISO 14630
Non-active surgical implants - General requirements
| Organization: | DS |
| Publication Date: | 2 January 2013 |
| Status: | active |
| Page Count: | 30 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
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.
Document History