prBAS EN ISO 18113-4:2025
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
General information
Status:Project
Number of pages:22
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) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
Lifecycle
...
Original document and degree of correspondence
EN ISO 18113-4:2024, identical
ISO 18113-4:2022, identical
Relation to BAS standards
Work material
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