Instrumentation to be used in association with non-active surgical implants - General requirements

Document Number: NL EN 12011 : 2010
Sector: Health Care Technology
TC: NL TC 3001
ICS: 11.040.30
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 system, but does not apply to the powered driven system itself. This standard is not applicable to instruments associated with dental implant, transendodontic and transradicular implants and ophthalmic implants. With regard to safety , this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.