prEN ISO 15194

Name: prEN ISO 15194
Brand: CEN
SKU: prEN ISO 15194
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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

Current stage: 40.60 Close of voting Mar 19, 2024

Originator: CEN

Owner: CEN/TC 140 In vitro diagnostic medical devices

Type: European Norm

ICS: 11.100.10 In vitro diagnostic test systems

Buying

Status: Draft

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

PREVIOUSLY

PUBLISHED
EN ISO 15194:2009

NOW

IN_DEVELOPMENT
prEN ISO 15194
40.60 Close of voting
Mar 19, 2024