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. This part of ISO describes requirements that, if met, will provide a radiation sterilization process intended to sterilize medical devices, that has appropriate microbicidal activity.
Furthermore, compliance with the requirements ensures that this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization.
Generic requirements of the quality management system for design and development, production, installation and servicing are given in ISO and particular requirements for quality management systems for medical device production are given in ISO The standards for quality management systems recognise that, for certain processes used in manufacturing, 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 is monitored routinely and the equipment is maintained. Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the products are sterile and, in this regard, suitable for its intended use.
This part of ISO describes the requirements for ensuring that the activities associated with the process of radiation sterilization are performed properly. These activities are described in documented work programmes designed to demonstrate that the radiation process will consistently yield sterile products on treatment with doses falling within the predetermined limits. The requirements are the normative parts of this part of ISO with which compliance is claimed.
The guidance given in the informative annexes is not normative and is not provided as a checklist for auditors. The guidance provides explanations and methods that are regarded as being a suitable means for complying with the requirements.
Methods other than those given in the guidance may be used, if they are effective in achieving compliance with the requirements of this part of ISO The development, validation and routine control of a sterilization process comprise a number of discrete but interrelated activities; e.
While the activities required by this part of ISO have been grouped together and are presented in a particular order, this part of ISO does not require that the activities be performed in the order that they are presented.
Check out our FAQs. Buy this standard. Abstract Preview ISO specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. ISO does not: specify requirements for 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; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.
Status : Published. Publication date : This standard contributes to the following Sustainable Development Goal :. CHF Buy. People also bought ISO Sterilization of health care products. ISO Sterilization of health care products. Part 3: Guidance on dosimetric aspects of development, validation and routine control. Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval.
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