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EVS-EN ISO 16061:2015

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)

General information
Valid from 08.06.2015
Base Documents
ISO 16061:2015; EN ISO 16061:2015
Directives or regulations
None
Standard history
Status
Date
Type
Name
Main
prEN ISO 16061
08.06.2015
Main
06.05.2010
Main
This International 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 resupplied after refurbishment. 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. 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. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
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