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ISO - DIS 18113-2

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

pending
Organization: ISO
Publication Date: 2 August 2021
Status: pending
Page Count: 17
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

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

This document can also be applied to accessories.

This document applies 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.

Document History

DIS 18113-2
August 2, 2021
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use. This document can also be applied to...
December 15, 2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the...

References

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