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Description of PD ISO/TS 19930:2017 2017This document 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
This document 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.
This document is applicable to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. This document does not apply
This document does not describe detailed procedures for assessing microbial inactivation. This document 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.
This document does not supersede or modify published International Standards for particular sterilization processes. This document neither recommends a SAL for a given health care product nor identifies a maximal SAL for a health care product to be labelled “sterile”.
About BSIBSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses. |
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