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ISO 18113-2:2022

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

standard by International Organization for Standardization , 09/30/2022

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Full Description

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.

This document can also be applicable to accessories.

This document is applicable to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

a) IVD instruments or equipment;

b) IVD reagents for self-testing.

 

Product Details

Published:
09/30/2022
File Size:
1 file , 2.3 MB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 18113-2:2022

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    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

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  2. ISO 18113-2:2009


    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

    • Historical Version