Standard

NS-EN ISO 11135-1:2007

Sept 2007 Withdrawn

Corrigendums and amendments are bought separately.

Language English

Services Read Online (No printing ) kr 947,00 Printed and bound Delivery time: 5-10 days kr 1 183,00

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

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Document information

Standard from SN
Published: 1 September 2007
Withdrawn: 1 October 2014
Edition: 1
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 93/42/EEC, 90/385/EEC

Product Relations

Replaced by: NS-EN ISO 11135:2014
Referred by: NS-EN ISO 10451:2010
Referred by: NS-EN ISO 22794:2009
Referred by: SN-CEN ISO/TS 11135-2:2008
Replaces: NS-EN 550:1994
Adopted from: EN ISO 11135-1:2007 , 0

Product life cycle

Previous product

Withdrawn

NS-EN 550:1994
Current product

Withdrawn

NS-EN ISO 11135-1:2007
Replaced by

Published

NS-EN ISO 11135:2014

NS-EN ISO 11135-1:2007

Access to standards for the entire organization

Benefits of our business solution:

Contact us today for a non-binding offer