BS EN ISO 11135:2014 pdf free.STERILIZATION OF HEALTH-CARE PRODUCTS – ETHYLENE OXIDE – REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES.
A sterile medical device is one that is free of viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems (see for example ISO 13485) might, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.
The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the ethylene oxide (EO); inevitably this means that there is always a finite probability that a microorganism might survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one medical device in a population subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a medical device.
ISO 11135 describes requirements that, if met, will provide an ethylene oxide sterilization process intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that validations conducted following this International Standard will provide products that meet the defined requirements for sterile products with a high degree of confidence. The specification for this probability is a matter for regulatory authorities and can vary from country to country (see for example EN 556-1 and ANSI/AAMI ST67).
Generic requirements of the quality management systems for design and development, production, installation and servicing are given in Iso 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognize that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process monitored routinely and the equipment maintained.
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 and, in this regard, suitable for its intended use. Attention is therefore given to a number of considerations including:
— the microbiological status of incoming raw materials and/or components;
— 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 product is stored.
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 moisturesensitive 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.BS EN ISO 11135:2014 pdf free download.