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

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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1   Scope

This Technical Report 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.
This Technical Report is intended for use by manufacturers, standardization bodies, regulatory bodies, and for conformity assessment purposes.