Standard [CURRENT]
DIN EN ISO 18113-2:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024
- German title
- In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller (Kennzeichnung) - Teil 2: In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal (ISO 18113-2:2022); Deutsche Fassung EN ISO 18113-2:2024
- Publication date
- 2024-10
- Original language
- German
- Pages
- 27
- Publication date
- 2024-10
- Original language
- German
- Pages
- 27
- DOI
- https://dx.doi.org/10.31030/3370948
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Overview
The DIN EN ISO 18113-2 standard specifies requirements for the provision of information by manufacturers of reagents for in vitro diagnostic tests. In addition, the standard also applies to the provision of information by manufacturers of calibration materials and control materials intended for use with in vitro diagnostic devices. Where applicable, the standards can also be applied to accessories. They apply to labels for outer and immediate containers and to the instructions for 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 systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Qualitätsmanagement in medizinischen Laboratorien" ("Quality management in medical laboratories") at DIN Standards Committee Medicine (NAMed) is responsible for this standard.
Content
ICS
DOI
This document replaces DIN EN ISO 18113-2:2013-01 .