ISO 11135 describes requirements for the ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings. Compliance with ISO 11135 ensures products that meet the defined requirements for sterile products with a high degree of confidence. Exposure to a properly validated, accurately controlled sterilization process is not the only factor
associated with the provision of reliable assurance that the product is sterile.
Attention is therefore given to several considerations in ISO 11135:
— the microbiological status of incoming raw materials,
— the validation and routine control of any cleaning and disinfection procedures used on the product,
— the control of the environment in which the product is manufactured or reprocessed, assembled and packaged,
— the control of equipment and processes,
— the control of personnel and their hygiene,
— the manner and materials in which the product is packaged,
— the conditions under which the product is stored.
The development, validation and routine control of a sterilization process comprises several discrete but interrelated activities. Such can be calibration, maintenance, product definition, process definition, installation qualification, operational qualification and performance qualification.
The international standard has been approved in Europe as EN ISO 11135:2014 without any changes and it supersedes EN ISO 11135-1:2007.
