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ISO 18113-2

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

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Organization: ISO
Publication Date: 15 December 2009
Status: active
Page Count: 18
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

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 manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

This part of ISO 18113 can also be applied to accessories.

This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.

This part of ISO 18113 does not apply to

a) IVD instruments or equipment,

b) IVD reagents for self-testing.

Document History

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...
ISO 18113-2
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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