ISO/TC 150
| Project No. | ISO 16061:2015 |
|---|---|
| Title | <p>ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.</p> <p>This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.</p> <p>With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.</p> <p>This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.</p> |
| Registration number (WIID) | 62113 |
| Scope | <p>ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.</p> <p>This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.</p> <p>With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.</p> <p>This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.</p> |
| Status | Atcelts |
| ICS group | 11.040.40 11.040.99 |