查看标准

适用范围：This part of ISO 11135 specifies requirements for the development, validation and routine control of anethylene oxide sterilization process for medical devices.NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements andprovides guidance that may be applicable to other health care products.Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such asscrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations havebeen produced in particular countries for the processing of materials potentially contaminated with theseagents.NOTE 2 See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3.This part of ISO 11135 does not detail a specified requirement for designating a medical device as sterile.NOTE 3 Attention is drawn to national or regional requirements for designating medical devices as “sterile”. See forexample EN 556-1 or ANSI/AAMI ST67.This part of ISO 11135 does not specify a quality management system for the control of all stages ofproduction of medical devices.NOTE 4 The effective implementation of defined and documented procedures is necessary for the development,validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered tobe elements of a quality management system. It is not a requirement of this part of ISO 11135 to have a complete qualitymanagement system during manufacture or reprocessing, but the elements of a quality management system that are theminimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see inparticular Clause 4). National and/or regional regulations for the provision of medical devices might require implementationof a complete quality management system and the assessment of that system by a third party.This part of ISO 11135 does not specify requirements for occupational safety associated with the design andoperation of ethylene oxide sterilization facilities.NOTE 5 For further information on safety, see examples in the Bibliography. National or regional regulations may alsoexist.NOTE 6 Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the possible existence in somecountries of regulations giving safety requirements for handling ethylene oxide and for premises in which it is used.This part of ISO 11135 does not cover sterilization by injecting ethylene oxide or mixtures containing ethyleneoxide directly into individual product packages, or continuous sterilization processes.