DIN EN ISO 18113-3
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022); German version EN ISO 18113-3:2024
In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO 18113-3:2022); Deutsche Fassung EN ISO 18113-3:2024
Overview
The present part of ISO 18113 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use. The present part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. The present part of ISO 18113 can also be applicable to accessories. The present part of ISO 18113 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 self-testing. This document has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" in collaboration with Technical Committee CEN/TC 140 "In vitro diagnostic systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Qualitätsmanagement in medizinischen Laboratorien" ("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
