In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022); German version FprEN ISO 18113-4:2022
Abstract
This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate container and to the instructions for use.
Begin
2019-12-06
WI
00140144
Planned document number
DIN EN ISO 18113-4
Project number
06301994
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 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021); German and English version prEN ISO 18113-4:2021
2021-09
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