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ISO 16061:2008
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Instrumentation for use in association with non-active surgical implants -- General requirements

This standard has been reviewed* and then confirmed in 2011.

*ISO standards are reviewed every five years.

Abstract

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.

 

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