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
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Status: WithdrawnPublication date: 2008-12
Corrected version (en): 2009-03
Corrected version (fr): 2009-03Stage: Withdrawal of International Standard [95.99] -
Edition: 2Number of pages: 19
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Technical Committee :ISO/TC 150
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Life cycle
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Previously
WithdrawnISO 16061:2000
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Now
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Revised by
WithdrawnISO 16061:2015
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