SR EN ISO 18113-5:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)

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.

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General information

Status : Valid
Approval date : 12/31/2024
Number of pages : 24
ICS : 11.100.10 In vitro diagnostic test systems
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 18113-5:2012