BS EN ISO 11135:2014+A1:2019

What is ISO 11135- Requirements for the development, validation, and routine control of a sterilization process about?

ISO 11135 discusses the sterilization of healthcare products. ISO 11135 is an international standard on requirements for the development, validation, and routine control of a sterilization process for medical devices

ISO 11135 outlines specific 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. ISO 11135 assists in the common need for quality systems, staff training, and proper safety measures for sterilization of healthcare products.

The major differences relate to the unique physical and organizational conditions in health care facilities, and the initial condition of reusable medical devices being presented for sterilization.

Note 1: 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 the myriads of activities that are performed to support that function.

Note 2: Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can apply to other health care products.

Who is ISO 11135- Requirements for the development, validation, and routine control of a sterilization process for?

ISO 11135 on the requirements for the development, validation, and routine control of a sterilization process for medical devices is useful for:

• Healthcare products manufacturers
• Test centers for healthcare products
• Regulatory authorities

Why should you use ISO 11135- Requirements for the development, validation, and routine control of a sterilization process?

A sterile medical device is free of viable microorganisms. Medical devices produced under standard manufacturing conditions with the requirements for quality management systems might, before sterilization, have microorganisms on them, albeit in low numbers. Patient safety must be addressed by minimizing exposure to ethylene oxide and its by-products during normal product use.

ISO 11135 guidelines assist you with quality management systems, sterilizing agent characterization, process and equipment characterization, product definition, process definition, validation, product release from sterilization, maintaining process effectiveness, and routine monitoring and control for ethylene oxide sterilization of healthcare products. This helps in controlling the environment in which the product is manufactured or reprocessed, assembled, and packaged. ISO 11135 also assists in controlling equipment, processes, personnel, and hygiene. In addition, helps validation and routine control of any cleaning and disinfection procedures used on the products