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.


General information

  • Status :  Withdrawn
    Publication date : 2008-12
    Corrected version (en) : 2009-03
    Corrected version (fr) : 2009-03
  • Edition : 2
    Number of pages : 19
  • Technical Committee
    :
    ISO/TC 150
    Implants for surgery
  • ICS :
    11.040.40
    Implants for surgery, prosthetics and orthotics
    11.040.99
    Other medical equipment

Life cycle


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