ISO 16061:2008
Instrumentation for use in association with non-active surgical implants -- General requirements
This standard has been revised by ISO 16061:2015.
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
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Current status : WithdrawnPublication date : 2008-12
Corrected version : 2009-03-16 -
Edition : 2
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- ICS :
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Other medical equipment
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Implants for surgery, prosthetics and orthotics
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Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
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Previously
ISO 16061:2000
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Now withdrawn
ISO 16061:2008 -
Revised by
ISO 16061:2015