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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This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
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 self-testing.
To find similar documents by classification:
11.100.10 (In vitro diagnostic test systems)
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Document Number
ISO 18113-3:2022
Revision Level
2ND EDITION
Status
Current
Publication Date
Oct. 1, 2022
Committee Number
ISO/TC 212