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); German version FprEN ISO 18113-2:2022
Abstract
This part of the DIN EN ISO 18113 series specifies requirements for information provided by the manufacturer of IVD reagents, calibrators and controls for professional use. Where applicable, this draft standard may also be applied to accessories. This part of DIN EN ISO 18113 applies to labels for the outer and primary containers and the instructions for use.
Begin
2019-12-06
WI
00140142
Planned document number
DIN EN ISO 18113-2
Project number
06301992
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 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021); German and English version prEN ISO 18113-2:2021
2021-09
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