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prEN ISO 15194

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023) prEN ISO 15194

Publication date:   Dec 21, 2023

General information

45.99 Dispatch of FV draft to CCMC   Jul 18, 2024

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.10   In vitro diagnostic test systems

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Draft

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Related legislation

Legislation related to this standard

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

Legislation 2017/746

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 15194:2009

NOW

IN_DEVELOPMENT
prEN ISO 15194
45.99 Dispatch of FV draft to CCMC
Jul 18, 2024