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ISO/TR 16142:2006 considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance. ISO/TR 16142:2006 is intended for use by manufacturers, standardization bodies, regulatory bodies, and for conformity assessment purposes.
 

Document History

  1. ISO 16142-1:2016


    Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

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  2. ISO/TR 16142:2006

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    Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

    • Historical Version
  3. ISO/TR 16142:1999


    Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

    • Historical Version