FprEN ISO 18113-2

Name: FprEN ISO 18113-2
Brand: CEN
SKU: FprEN ISO 18113-2
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022) FprEN ISO 18113-2

Publication date: Aug 5, 2021

General information

Current stage: 60.55 Ratification completed (DOR) Oct 2, 2022

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

Scope

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.
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 self-testing.

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 18113-2:2011

NOW

IN_DEVELOPMENT
FprEN ISO 18113-2
60.55 Ratification completed (DOR)
Oct 2, 2022