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About This Item
Full Description
ISO 16061:2008 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.
ISO 16061:2008 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, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
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
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
viewing
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