CEN/TC 204/WG 9 - General requirements for sterilization
Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored.
General requirements for sterilization
Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored.
General Information
Frequently Asked Questions
CEN/TC 204/WG 9 is a Working Group within the European Committee for Standardization (CEN). It is named "General requirements for sterilization" and is responsible for: Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored. This committee has published 3 standards.
CEN/TC 204/WG 9 develops CEN standards. The scope of work includes: Preparation of standards providing general criteria by which sterilization processes (except the processes covered by EN 550, EN 552 and EN 554) can be validated and routinely monitored. Currently, there are 3 published standards from this working group.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Working Group in CEN is a specialized group responsible for developing standards or technical work within a defined scope. These bodies bring together international experts to create consensus-based standards that support global trade, safety, and interoperability.
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.
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