DIN EN ISO 14160:2011-10

The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" (secretariat: ANSI, USA), in collaboration with CEN/TC 204 "Sterilization of medical devices" (secretariat: BSI, United Kingdom). The responsible German committee is Working Committee NA 063-01-07 AA "Sterilisation von Medizinprodukten" ("Sterilization of medical devices") at NAMed. The first edition of the standard was published in 1998. The standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of medical devices. It applies to single-use medical devices comprising, in whole or in part, materials of animal origin. The standard covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. The part containing the requirements has been supplemented by normative annexes covering the determination of the lethal rate of the sterilization process and by an informative annex which contains guidance for the requirements. The International Standard has been comprehensively revised and the second edition was published. The significant amendments concern the requirements for: - quality management system elements, - sterilizing agent characterization and process and equipment characterization, - validation, - product release (parametric release), - maintaining process effectiveness; normative annexes determination of lethal rate of the sterilization process have been supplemented. DIN EN ISO 14160 has been prepared under a mandate of the European Commission and supports essential requirements of Directive 93/42/EEC on medical devices.