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Full Description

This technical information report considers and identifies certain significant standards and guides useful in the assessment of product conformity with recognized essential principles of safety and performance of medical devices. It is intended for use by manufacturers, standardization bodies, regulatory bodies, and for conformity assessment purposes.
 

Document History

  1. AAMI/ISO TIR16142:2005

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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

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  2. AAMI/ISO TIR 16142


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

    • Historical Version