In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2022); German version FprEN ISO 18113-1:2022
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
Order from DIN Media
