BS EN ISO 25424-2011 医疗设备消毒.低温蒸汽和甲醛.医疗设备消毒流程的开发,确认和常规控制要求

标准号：BS EN ISO 25424-2011
中文标准名称：医疗设备消毒.低温蒸汽和甲醛.医疗设备消毒流程的开发,确认和常规控制要求
英文标准名称：Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
标准类型：C47
发布日期：2011/8/31 12:00:00
实施日期：2011/8/31 12:00:00
中国标准分类号：C47
国际标准分类号：11.080.01
引用标准：EN 14180-2003;EN ISO 11138-1;EN ISO 11138-5-2006;EN ISO 11140;EN ISO 11737-1;EN ISO 11737-2;EN ISO 13485
适用范围：1.1 Inclusions1.1.1 This European Standard specifies requirements for the development, validation and routine control ofa Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.NOTE Although the scope of this standard is limited to medical devices, it specifies requirements and providesguidance that may be applicable to other products and equipment.1.1.2 This European Standard is intended to be applied by process developers, manufacturers ofsterilization equipment, manufacturers of medical devices to be sterilized and the organizations withresponsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1)1.1.3 This European Standard covers sterilization processes which use a mixture of low temperature steamand formaldehyde as sterilant, and which are working below ambient pressure only.1.2 Exclusions1.2.1 Sterilization processes validated and controlled in accordance with the requirements of this standardshould not be assumed to be effective in inactivating the causative agents of spongiform encephalopathiessuch as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specificrecommendations have been produced in particular countries for the processing of materials potentiallycontaminated with these agents.1.2.2 This standard does not specify requirements for designating a medical device as “STERILE”. Suchrequirements are given in EN 556-1.1.2.3 This standard does not specify a quality management system for the control of all stages ofproduction of medical devices.NOTE It is not a requirement of this standard to have a complete quality management system during manufacture orreprocessing, but those elements of such a system that are required are normatively referenced at appropriate places inthe text. Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages ofproduction or reprocessing of medical devices including the sterilization process. Further guidance is given in E.2 ofEN ISO 14937:2000.1.2.4 This standard does not specify requirements for occupational safety associated with the design andoperation of LTSF sterilization facilities.NOTE 1 Safety requirements for sterilizers are specified in EN 61010-2-040.NOTE 2 Attention is also drawn to the existence in some countries of regulations stipulating safety requirements.1.2.5 This European Standard does not cover analytical methods for determining levels or residues offormaldehyde and/or its reaction products.NOTE 1 Attention is drawn to EN 14180.NOTE 2 Attention is drawn to the possible existence in some countries of statutory regulation specifying limits for thelevel of formaldehyde residues on medical devices and products.1.2.6 This European Standard does not cover preparatory measures that may be necessary beforesterilization such as cleaning, disinfection and packing.NOTE For re-sterilizable medical devices, the manufacturer(s) of these devices should supply information on thepreparatory measures (see EN ISO 17664).