DANSK DS/ISO/TS 19930 PDF

ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6. In addition, this document provides a) background information on the assurance of sterility and sterility assurance level, and b) guidance on strategies that can allow the achievement of a maximal SAL of 10−6. ISO/TS 19930:2017 describes the elements of a quality management system which are applied to enable the appropriate selection of a SAL for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10−6. NOTE – It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product. ISO/TS 19930:2017 is applicable to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. ISO/TS 19930:2017 does not apply - to selecting a maximal SAL greater than 10−6 for health care product that is able to withstand processing to achieve maximally a SAL of 10−6; - in cases where a maximal SAL of 10−6 is required and an alternative SAL is not allowed; - in cases where a maximal SAL of greater than 10−6 (e.g. 10−3) has been accepted by regulatory authorities within their jurisdiction for health care product for defined use; - to the sterilization of used or reprocessed health care product; - to sterilization of health care product by filtration. ISO/TS 19930:2017 does not describe detailed procedures for assessing microbial inactivation. ISO/TS 19930:2017 does not specify requirements for the 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE – See also ISO 22442‑1, ISO 22442‑2 and ISO 22442‑3. ISO/TS 19930:2017 does not supersede or modify published International Standards for particular sterilization processes. ISO/TS 19930:2017 neither recommends a SAL for a given health care product nor identifies a maximal SAL for a health care product to be labelled "sterile". NOTE – These are matters for regulatory authorities and can vary from country to country.