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  1. Home
  2. ISO 20916:2019

ISO 20916:2019 ✓ Most Recent

2075295  Preview

In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice

standard by International Organization for Standardization , 05/01/2019

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Identical Versions Available

  • BS ISO 20916:2019

    June 2019
    In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

    • Historical Version

Full Description

ISO 20916:2019 defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.

The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study.

This document identifies the principles that underpin clinical performance studies and specifies general requirements intended to
  • ensure the conduct of the clinical performance study will lead to reliable and robust study results,
  • define the responsibilities of the sponsor and principal investigator,
  • assist sponsors, clinical research organization, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of IVD medical devices, and
  • protect the rights, safety, dignity and well-being of the subjects providing specimens for use in clinical performance studies.
Analytical performance studies are out of the scope of this document.
See more

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Price: $259.00
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Product Details

Edition:

1st

Published:

05/01/2019

Number of Pages:

68

File Size:

1 file , 2.9 MB

Same As:

BS ISO 20916:2019

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