DNS/ISO 11135: 2014


Status: Public comments
Start date: 20240718
End date: 20240916

1.1 Inclusions 

This International Standard specifies requirements for the development, validation and routine control  of an ethylene oxide sterilization process for medical devices in both the industrial and health care  facility 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 safety  measures. The major differences relate to the unique physical and organizational conditions in health care  facilities, 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 processing  areas, 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 one  of 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 sterilize  large 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 different  descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of  cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International  Standard, 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 moisture sensitive medical devices that cannot be moist heat sterilized. 

NOTE 5     Although the scope of this International Standard is limited to medical devices, it specifies requirements  and provides guidance that can be applicable to other health care products. 

1.2 Exclusions 

1.2.1    This International Standard does not specify requirements for the development, validation and  routine control of a process for inactivating the causative agents of spongiform encephalopathies such  as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations  have been produced in particular countries for the processing of materials potentially contaminated with  these agents. 

NOTE       See ISO 22442-1, ISO 22442-2 and ISO 22442-3. 

1.2.2   This International Standard does not detail a specified requirement for designating a medical  device as sterile. 

NOTE      Attention is drawn to national or regional requirements for designating medical devices as “sterile”.  See for example EN 556–1 or ANSI/AAMI ST67. 

1.2.3   This International Standard does not specify a quality management system for the control of all  stages of production of medical devices.

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