In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022); German version FprEN ISO 18113-5:2022
Abstract
This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. Furthermore, this part of DIN EN ISO 18113 also applies to apparatus, equipment, calibrator and control materials intended to be used with IVD instruments for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate.
Begin
2019-12-06
WI
00140145
Planned document number
DIN EN ISO 18113-5
Project number
06301995
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 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021); German and English version prEN ISO 18113-5:2021
2021-09
Order from DIN Media
