Overview

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The revision of the 2009 standard became necessary due to the 2007 amendment of Council Directive 93/42/EC on medical devices. The aim of the revision was to close gaps identified in the informative Annex ZA, which contains the relevant requirements of EC Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and Council Directive 93/42/EC concerning medical devices, and Directive 98/8/EC concerning the placing of biocidal products on the market. The standard specifies the essential performance requirements for large steam sterilizers, including associated test methods. These include, for example, requirements for steam penetration, compliance with physical parameters and dryness of the load after sterilization. Among other things, the scope of application has been revised in order to define a clear demarcation to small sterilizers via the chamber size. New additions include, for example, the requirements for transport or verification and validation of the software. An annex on protective measures has also been added. The standard serves to implement essential requirements of Directive 93/42/EEC on medical devices. The European Standard has been prepared by CEN/TC 102 "Sterilizers for medical purposes", the secretariat of which is held by DIN. The responsible German committee is DIN Standards Committee Medicine, Working Committee NA 063-04-01 AA "Dampfsterilisatoren" ("Steam sterilizers").

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-03 AA - Steam sterilizers  

Responsible european committee

CEN/TC 102/WG 5 - Steam sterilizers