Standard

NS-EN ISO 18113-5:2009

Mar 2010 Withdrawn

Note: This standard has a new edition: NS-EN ISO 18113-5:2024

Corrigendums and amendments are bought separately.

Language English

Services Read Online (No printing ) kr 772,00 Printed and bound Delivery time: 5-10 days kr 965,00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to a) instructions for instrument servicing or repair, b) IVD reagents, including calibrators and control materials for use in control of the reagent, c) IVD instruments for professional use.

Document information

Standard from SN
Published: 1 March 2010
Withdrawn: 1 January 2012
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.100.10
National Committee SN/K 116

Legal references

EU law: 98/79/EC

Product Relations

Replaced by: NS-EN ISO 18113-5:2011
Replaces: NS-EN 592:2002
Adopted from: EN ISO 18113-5:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN 592:2002
Current product

Withdrawn

NS-EN ISO 18113-5:2009
Replaced by

Withdrawn

NS-EN ISO 18113-5:2011

NS-EN ISO 18113-5:2009

Access to standards for the entire organization

Benefits of our business solution:

Contact us today for a non-binding offer

NS-EN ISO 18113-5:2024

NS-EN ISO 18113-5:2011