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About This Item
Full Description
ISO 16061:2015 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.
Document History
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ISO 16061:2021
Instruments for use in association with non-active surgical implants - General requirements- Most Recent
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ISO 16061:2015
viewing
Instrumentation for use in association with non-active surgical implants - General requirements- Historical Version
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ISO 16061:2015 Plus Redline
Instrumentation for use in association with non-active surgical implants - General requirements (includes Redline Version)- Historical Version
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ISO 16061:2008
Instrumentation for use in association with non-active surgical implants - General requirements- Historical Version
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ISO 16061:2000
Instrumentation for use in association with non-active surgical implants - General requirements- Historical Version