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About This Item
Full Description
ISO 16061:2021 specifies the 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 supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term "instrument" refers to an instrument for use in association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document 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
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Instruments for use in association with non-active surgical implants - General requirements- Most Recent
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ISO 16061:2015
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