CEN/TC 102/WG 2 - Testing
This Working Group is responsible for the standardization of tests for large steam sterilizers intended for the sterilization of medical devices.
Testing
This Working Group is responsible for the standardization of tests for large steam sterilizers intended for the sterilization of medical devices.
General Information
Frequently Asked Questions
CEN/TC 102/WG 2 is a Working Group within the European Committee for Standardization (CEN). It is named "Testing" and is responsible for: This Working Group is responsible for the standardization of tests for large steam sterilizers intended for the sterilization of medical devices. This committee has published 2 standards.
CEN/TC 102/WG 2 develops CEN standards. The scope of work includes: This Working Group is responsible for the standardization of tests for large steam sterilizers intended for the sterilization of medical devices. Currently, there are 2 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.
TC - Wrong translation of a clause
- Corrigendum2 pagesEnglish languagee-Library read for1 day
1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of one or more sterilization modules for wrapped goods (instruments etc. and porous loads). Large steam sterilizers can also be used during the commercial production of medical devices. Note: Sterilizers conforming to this standard can offer a single automatic sterilization cycle or a number of selectable automatic sterilization cycles, e.g. with different operating temperatures (see 28.3b). 1.2 This European Standard is not applicable to small steam sterilizers nor to steam sterilizers used for the sterilization of pharmaceutical products in containers. Note: The use of sterilizers for unwrapped instruments and utensils for immediate use in aseptic areas and for fluid-sterilizers will be the subject of a separate standards. 1.3 This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer. Note: Attention is drawn to the standards for quality systems (see EN ISO 9001, EN ISO 9002, EN ISO 9004-1 and EN 46001 and EN 46002).
- Standard82 pagesEnglish languagee-Library read for1 day