SS-EN-ISO-16061 › Historical Revision Information
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
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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, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer. This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.
To find similar documents by classification:
11.040.99 (Other medical equipment)
Medical devices
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Designation Name
SS-EN ISO 16061:2008
Revision Level
2008 EDITION
Status
Superseded
Publication Date
Dec. 15, 2008
Language(s)
English
Page Count
36
International Equivalent
EN ISO 16061:2008(IDT); ISO 16061:2008(IDT)