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ISO 16061:2008

Instrumentation for use in association with non-active surgical implants — General requirements

Standard Details

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Status : WITHDRAWN
Standard Type: Main
Document No: ISO 16061:2008
Document Year: 2008
Pages: 19
Edition: 2
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics
  • 11.040.99 Other medical equipment

Life Cycle

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ISO 16061:2008
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