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ISO 18113-3

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

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Organization: ISO
Publication Date: 15 December 2009
Status: active
Page Count: 16
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 instruments for professional use.

This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

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

This part of ISO 18113 does not apply to:

a) instructions for instrument servicing or repair,

b) IVD reagents, including calibrators and control materials for use in control of the reagent,

c) IVD instruments for self-testing.

Document History

August 2, 2021
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
This document specifies requirements for information supplied by the manufacturer of IVD instruments intended for professional use. This document also applies to apparatus and equipment intended to...
ISO 18113-3
December 15, 2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment...

References

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