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ISO - 18113-5

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing

active, Most Current
Organization: ISO
Publication Date: 1 October 2022
Status: active
Page Count: 16
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.

This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.

This document can also be applicable to accessories.

This document 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 professional use.

Document History

18113-5
October 1, 2022
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus...
December 15, 2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment...

References

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