Overview

The standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases. Amongst other things, it specifies requirements for risk control, materials, sterilizer chamber, design and construction, the measuring instruments used, software validation, sterilizing cycle, automatic control and sterilizer performance. Furthermore, test equipment and tests in connection with the sterilizer chamber as well as microbiological tests for EO sterilizers are described in the annexes. An informative annex on environmental aspects provides information for application and impacts of ethylene oxide regarding the life cycle of EO sterilizers. This European Standard does not cover sterilization by EO or EO mixtures injected directly into packages nor risk analysis which shall be carried out during design of an EO sterilizer. The standard applies for the application in health care facilities, medicinal product enterprises or enterprises for sterilization processes for sterilization of medicinal products and accessories. Within the framework of the revision of the European Standard from 2007, in particular the layout and structure of the document has been adjusted to International Standards (see ISO 11135). Furthermore, requirements, in particular safety requirements for machinery (sterilizer) have been checked and where necessary, revised, in order to represent the Essential Requirements of EU Directive 93/42/EEC on medical devices (as amended by EC Directive 2007/47/EC) (see also Annex ZA). Requirements for the development, validation and control of the application of a sterilization process for medical products during EO sterilization of health care products are specified in standard DIN EN ISO 11135. The standard has been prepared by CEN/TC 102 "Sterilization of medical devices" the secretariat of which is held by DIN. The responsible German committee is Working Committee NA 063-04-02 AA "Niedertemperatur-Sterilisatoren" ("Low-temperature sterilizers") at NAMed.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-03-04 AA - Low temperature sterilizers  

Responsible european committee

CEN/TC 102/WG 6 - Low temperature sterilizers