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dnaSRPS EN ISO 15194:2022

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/FDIS 15194:2026)

General information

50.20     Mar 26, 2026

50.60    May 20, 2026

ISS

Z076

European Norm

11.100.10  

English  

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

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

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15194:2011

PUBLISHED
SRPS EN ISO 15194:2015

NOW

PROJECT
dnaSRPS EN ISO 15194:2022
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Mar 26, 2026

Related project

Adopted from FprEN ISO 15194 IDENTICAL

Adopted from ISO/FDIS 15194 IDENTICAL

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