Standards [CURRENT]

DIN EN ISO 18113-4
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011

Title (German)

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 4: Reagenzien für in-vitro-diagnostische Untersuchungen zur Eigenanwendung (ISO 18113-4:2009); Deutsche Fassung EN ISO 18113-4:2011

Overview

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of in vitro diagnostic reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturers of calibrators and control materials intended for use with in vitro diagnostic medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.

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  

Edition 2013-01
Original language German
Translation English
Price from 77.90 €
Table of contents

Contact

Dipl.-Ing. (FH)

Björn Hermes

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