We use cookies to make our websites more user-friendly and to continuously improve them. If you continue to use the website, you consent to the use of cookies. You can find more information in our privacy statement and our cookie guidelines.

&nbsp
International Customer Service
Phone +49 30 2601-2759
Fax +49 30 2601-1263

Standard [CURRENT]

DIN EN ISO 18113-4:2013-01

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

German title
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
Publication date
2013-01
Original language
German
Pages
20

Please select

from 72.00 EUR VAT included

from 67.29 EUR VAT excluded

Purchasing options

PDF download

  • 72.00 EUR

  • 86.40 EUR

  • 90.10 EUR

Shipment (3-5 working days)

  • 86.90 EUR

  • 108.90 EUR

Standards Ticker 1
1

Learn more about the standards ticker

Online service subscriptions

This document also features in an online service. Online services not only give you electronic access to collections of standards, they contain lots of extra information too (such as directives, legal texts, commentaries, etc.). There are automatic updates on a regular basis – and online services also give you large savings compared with the cost of purchasing standards individually.

Suitable online services
Publication date
2013-01
Original language
German
Pages
20
DOI
https://dx.doi.org/10.31030/1923433

Product information on this site:

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice 

All transactions are encrypted

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.

Content
ICS
11.100.10
DOI
https://dx.doi.org/10.31030/1923433
Replacement amendments

This document replaces DIN EN ISO 18113-4:2010-05 .

Cooperation at DIN

Also available in
Relationship to other standards
This document references:
This document is referenced in:
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...