
Instrumentation To Be Used In Association With Non-active Surgical Implants - General Requirements
出版:Swiss Standards

专家解读视频
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 12011:1998 - Identical
DIN EN 12011 (1998-03) - Identical
BS EN 12011:1998 - Identical
UNI EN 12011:2000 - Identical
SS EN 12011 Ed. 1 (1998) - Identical
NS EN 12011 Ed. 1 (1998) - Identical
I.S. EN 12011:1998 - Identical
NF EN 12011:1998 - Identical
NBN EN 12011:1998 - Identical
UNE EN 12011:1998 - Identical
NEN EN 12011:1998 - Identical