Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
医疗保健产品的消毒 医疗器械用杀菌剂的特性、杀菌过程的开发、验证和常规控制的一般要求
Cross References:ISO 10012ISO 10993-1ISO 10993-17ISO 11138-1:2006ISO 11140-1ISO 11737-1ISO 11737-2ISO 13485:2003IEC 61010-2-040ISO 9000:2005, QualityISO 9001ISO 9004ISO 11135-1ISO 11137-1ISO 11137-2ISO/TS 11139:2006ISO 11607-1ISO 11607-2ISO 14001ISO 14040ISO 14160ISO 14161ISO 14971ISO 15883ISO/IEC 17025ISO 17664ISO 17665-1ISO 20857ISO 22442-1ISO 22442-2ISO 22442-3ISO 90003EN 556-1AAMI ST6790/385/EEC93/42/EEC98/79/ECAll current amendments available at time of purchase are included with the purchase of this document.