This part of the ISO 11134 standard, developed by the International Organization for Standardization (ISO), specifies the requirements for the use of moist heat in the development of the sterilization process, validation of the sterilization process, and control of routine sterilization.
It covers all moist heat treatments, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contracted moist heat sterilization. Although moist heat sterilization is not specifically covered in non-industrial healthcare facilities, the principles outlined may be beneficial for users of moist heat sterilization in these facilities.
While the general requirements of this International Standard may apply to the sterilization of pharmaceuticals, other technical or regulatory requirements may also apply. This International Standard does not cover the quality assurance system necessary to control all stages of production, including the sterilization process.
Having a complete quality management system during production is not a requirement of this part of ISO 11137, but the elements of the quality management system that are the minimum necessary to control the sterilization process are normatively referred to in the text where appropriate. Attention is drawn to the standards of quality management systems that control all stages of the production of medical devices, including the sterilization process. Regional and national regulations regarding the provision of medical devices may require the implementation of a complete quality management system and its evaluation by a third party.
Among the services provided by our organization within the framework of material testing services, there are also ISO 11134 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.
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