In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022); German version FprEN ISO 18113-3:2022
Abstract
This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. Furthermore, this part of DIN EN ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate.
Begin
2019-12-06
WI
00140143
Planned document number
DIN EN ISO 18113-3
Project number
06301993
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 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021
2021-09
Order from Beuth Verlag
