ISO 11135:2014 灭菌医疗产品 环氧乙烷 医疗器械灭菌验证、批准和常规控制过程的要求

标准编号：ISO 11135:2014

中文名称：灭菌医疗产品 环氧乙烷 医疗器械灭菌验证、批准和常规控制过程的要求

英文名称：Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

发布日期：2014-07

标准范围

This International Standard specifies requirements for the development, validation and routine controlof an ethylene oxide sterilization process for medical devices in both the industrial and health carefacility settings, and it acknowledges the similarities and differences between the two applications.NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safetymeasures. The major differences relate to the unique physical and organizational conditions in health carefacilities, and to the initial condition of reusable medical devices being presented for sterilization.NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processingareas, in the equipment used, and in the availability of personnel with adequate levels of training and experience.The primary function of the health care facility is to provide patient care; medical device reprocessing is just oneof a myriad of activities that are performed to support that function.NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilizelarge numbers of similar medical devices that have been produced from virgin material. Health care facilities,on the other hand, must handle and process both new medical devices and reusable medical devices of differentdescriptions and with varying levels of bioburden. They are therefore faced with the additional challenges ofcleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this InternationalStandard, alternative approaches and guidance specific to health care facilities are identified as such.NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisturesensitivemedical devices that cannot be moist heat sterilized.NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirementsand provides guidance that can be applicable to other health care products.

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