DIN EN ISO 18113-1:2024-10
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024
| Edition date: |
2024-10-01
In Force
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|---|---|
| Available languages: | English, German |
| Summary: | This Standard defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. |
| Keywords: | Apparatus for analysis|Applications|Data of the manufacturer|Definitions|Diagnosis (medical)|Diagnostic equipment|Diagnostic systems|Enterprises|Experts|In vitro|Information|Information supplied by the manufacturer|Inscription|Instructions for use|Investigations|In-vitro diagnostic|Labelling|Laboratory medicine|Marking|Medical equipment|Medical products|Medical sciences|Medical technology|Operational instructions|Product information|Self-testing|Specification (approval)|Terminology|User information|Vocabulary |
| ICS: | 11.100.10-In vitro diagnostic test systems, 01.040.11-Health care technology (Vocabularies) |
| CTN: | |
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International Equivalence |
Identic EN ISO 18113-1:2024 Identic ISO 18113-1:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 18113-1:2013-01 Reemplaza a DIN EN ISO 18113-1:2021-09 |










