Standard

NS-EN ISO 14937:2009

Feb 2010 Published

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Language English

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Abstract

ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.

Document information

Standard from SN
Published: 1 February 2010
Edition: 2009-10
Version: 1
Document type: NAT
ISBN:

ICS 11.080.01
National Committee CEN/TC 204

Legal references

EU law: 90/385/EEC, 93/42/EEC, 98/79/EC

Product Relations

Referred by: NS-EN ISO 80601-2-74:2021
Referred by: NS-EN ISO 80601-2-69:2020
Referred by: NS-EN ISO 80601-2-67:2020
Referred by: NS-EN ISO 10451:2010
Referred by: NS-EN 13060:2004+A2:2010
Replaces: NS-EN ISO 14937:2000
Adopted from: EN ISO 14937:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 14937:2000/AC:2005

Withdrawn

NS-EN ISO 14937:2000
Current product

Published

NS-EN ISO 14937:2009

NS-EN ISO 14937:2009

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