BS EN 12011:1998
Instrumentation to be used in association with non-active surgical implants - General requirements
- Standard No.
- BS EN 12011:1998
- Release Date
- 1998
- Published By
- British Standards Institution (BSI)
- Status
- 2009-05
- Replace By
- BS EN ISO 16061:2008
- Latest
- BS EN ISO 16061:2015
- Scope
- This European Standard 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 re-supplied after refurbishment. This standard applies to instruments which may be connected to powered driven systems, but does not apply to the powered driven system itself. This standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. With regard to safely, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.
BS EN 12011:1998 history
- 2015 BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
- 2009 BS EN ISO 16061:2009 Instrumentation for use in association with non-active surgical implants - General requirements
- 0000 BS EN ISO 16061:2008
- 1998 BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants - General requirements
