DIN EN ISO 18113-5
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022); German version EN ISO 18113-5:2024
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 5: Geräte für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-5:2022); Deutsche Fassung EN ISO 18113-5:2024
Overview
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applicable to accessories. This document does not apply to: a) instructions for instrument servicing or repair; b) IVD reagents, including calibrators and control materials for use in control of the reagent; c) IVD instruments for professional use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use. This document has been prepared by Technical Committee ISO/TC 212 " Medical laboratories and in vitro diagnostic systems" in collaboration with Technical Committee CEN/TC 140 "In vitro diagnostic medical devices" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Quality management in medical laboratories" at DIN Standards Committee Health Technologies (NAGesuTech) is responsible for this standard.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-08-08 AA - Quality management in medical laboratories
Responsible european committee
CEN/TC 140 - In vitro diagnostic medical devices
