1594475

ISO 16061:2008

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

standard by International Organization for Standardization , 12/01/2008

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Full Description

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.

 

Product Details

Published:
12/01/2008
File Size:
1 file , 190 KB
Same As:
BS EN ISO 16061:2009, DIN EN ISO 16061
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 16061:2021


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

    • Most Recent

  2. ISO 16061:2015


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

    • Historical Version

  3. ISO 16061:2015 Plus Redline


    Instrumentation for use in association with non-active surgical implants - General requirements (includes Redline Version)

    • Historical Version

  4. ISO 16061:2008

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

    • Historical Version

  5. ISO 16061:2000


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

    • Historical Version