ISO-16061 › Historical Revision Information
Instrumentation for use in association with non-active surgical implants - General requirements
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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.
To find similar documents by classification:
11.040.99 (Other medical equipment)
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Document Number
ISO-16061
Revision Level
2ND EDITION
Status
Superseded
Publication Date
Dec. 1, 2008
Committee Number
ISO/TC 150