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.
Status : WithdrawnPublication date : 2008-12
Corrected version (en) : 2009-03
Corrected version (fr) : 2009-03
Edition : 2Number of pages : 19
Technical Committee:Implants for surgery