Abstract

This Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

Begin

2019-12-06

WI

00140141

Planned document number

DIN EN ISO 18113-1

Project number

06301991

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212/WG 3 - In vitro diagnostic products  

draft standard

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2021); German and English version prEN ISO 18113-1:2021
2021-09
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previous edition(s)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
2013-01

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