prBAS EN ISO 18113-5:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
General information
Status:Project
Number of pages:21
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:22.10.2024
Forseen date for next stage code:12.03.2025
Technical committee:BAS/TC 25, Healthcare
Directives:
2017/746, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
ICS:
11.100.10, In vitro diagnostic test systems
Abstract
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.
Lifecycle
...
Original document and degree of correspondence
EN ISO 18113-5:2024, identical
ISO 18113-5:2022, identical
Relation to BAS standards
Work material
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