DIN EN ISO 18113-4:2013 Edition

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In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing

Published By	Publication Date	Number of Pages
DIN	2013-01	20

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Categories: 11.100.10 - In vitro diagnostic test systems, DIN

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Description

This part of DIN EN ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. Furthermore, this part of DIN EN ISO 18113 applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of DIN EN ISO 18113 can also be applied to accessories, where appropriate. This part of DIN EN ISO 18113 applies to labels for the outer and immediate container and to the instructions for use.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2013-01
Pages Count	20
Language	Germany
Descriptors	Apparatus for analysis, Applications, CE marking, Data of the manufacturer, Diagnosis (medical), Diagnostic equipment, Diagnostic systems, Enterprises, In vitro, Information, Instructions for use, Investigations, In-vitro diagnostic, Labelling, Labels, Laboratory medicine, Marking of roads, Medical equipment, Medical sciences, Medical technology, Operational instructions, Reagents, Self-testing, Specification (approval), User information, Diagnosis, Implementation, Use
File Size	399.4 KB
ICS Codes	11.100.10 - In vitro diagnostic test systems

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DIN EN ISO 18113-4:2013 Edition

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