Defines general requirements for instruments for use in association with non-active surgical implants. Applicable to instruments at the time of manufacture and when they are re-supplied following refurbishment. Applicable to instruments for connection to powered driven systems, but not to the powered driven system itself. Does not apply to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants. Regarding safety, states requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer.

ONORM EN ISO 16061:2010

NF EN 12011:1998 - Identical

NBN EN 12011:1998 - Identical

UNI EN 12011:2000 - Identical

I.S. EN 12011:1998 - Identical

NS EN 12011 Ed. 1 (1998) - Identical

SS EN 12011 Ed. 1 (1998) - Identical

UNE EN 12011:1998 - Identical

SN EN 12011:1998 - Identical

NEN EN 12011:1998 - Identical

BS EN 12011:1998 - Identical

DIN EN 12011 (1998-03) - Identical