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Normas DIN – AENOR
DIN EN 13532:1999-08

DIN EN 13532:1999-08

General requirements for in-vitro diagnostic medical devices for self-testing; German version prEN 13532:1999

Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro destinés à des auto-diagnostics; Version allemande prEN 13532:1999

Allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung; Deutsche Fassung prEN 13532:1999

Fecha Anulación:
2012-08 /Withdrawn
Equivalencias internacionales:

prEN 13532 (1999-05)

Relación con otras normas DIN:

Reemplazada por: DIN EN 13532:2002-08

Resumen:
The document specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purpose as specified by the manufacturer. The document does not address medical aspects of IVD MDs for self-testing.
Das Dokument legt allgemeine Anforderungen an In-vitro-Diagnostika zur Eigenanwendung fest. Es soll sicherstellen, daß In-vitro-Diagnostika zur Eigenanwendung sicher und für die vom Hersteller angegebenen Zwecke geeignet sind. Das Dokument behandelt keine medizinischen Aspekte von In-vitro-Diagnostika zur Eigenanwendung.
Keywords:
Applicability, Definitions, Diagnosis, Diagnosis (medical), Diagnostic equipment, In-vitro diagnostic, Labelling (process), Marking, Medical sciences, Product information, Reagents, Self-testing, Specification (approval)
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