ISO 11135 Ethylene Oxide - Requirements for Developing a Sterilization Process for Medical Devices

Developed by the International Organization for Standardization (ISO), this part of the ISO 11135 standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings and acknowledges the similarities and differences between the two applications.

The similarities include the common need for quality systems, staff training and appropriate safety measures. The main differences relate to the unique physical and organizational conditions in healthcare facilities and the initial availability of reusable medical devices available for sterilization.

Healthcare facilities differ from medical device manufacturers in the physical design of processing areas, the equipment used, and the availability of personnel with adequate training and experience. The primary function of the healthcare facility is to provide patient care; medical device reprocessing is just one of the many activities undertaken to support this function.

In terms of the initial state of medical devices, medical device manufacturers usually sterilize a large number of similar medical devices made of pure material. Healthcare facilities, on the other hand, must handle and process both new medical devices and reusable medical devices with different definitions and different bioburden levels. Therefore, they face additional challenges such as cleaning, evaluating, preparing and packaging a medical device prior to sterilization. This International Standard defines alternative approaches and guidelines specific to healthcare facilities as such.

EO gas and its mixtures are effective sterilizers primarily used for heat and/or moisture sensitive medical devices that cannot be sterilized by moist heat. While the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance applicable to other healthcare products.

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 made in certain countries for the handling of materials potentially contaminated with these agents.

This International Standard does not detail an established requirement to determine a medical device as sterile. Attention is drawn to national or regional requirements for the sterilization of medical devices. For example EN 556-1 or ANSI/AAMI ST67. This International Standard does not specify a quality management system for the control of all stages of the manufacture of medical devices.

Effective implementation of defined and documented procedures is essential for the development, validation and routine control of a sterilization process for medical devices. Such procedures are generally considered elements of a quality management system. It is not a requirement of this International Standard to have a complete quality management system during production or rework. Required elements are referenced normatively in the text where appropriate. Attention is drawn to quality management systems standards that control all production or reprocessing stages of medical devices. National or regional regulations regarding the provision of medical devices may require the implementation of a complete quality management system and its evaluation by a third party.

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