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.<\/p>\n
In addition, this document provides<\/p>\n
a) background information on the assurance of sterility and sterility assurance level, and<\/p>\n
b) guidance on strategies that can allow the achievement of a maximal SAL of 10-6.<\/p>\n
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.<\/p>\n
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.<\/p>\n
ISO\/TS 19930:2017 is applicable to sterilization processes in which microorganisms are inactivated by physical and\/or chemical means.<\/p>\n
ISO\/TS 19930:2017 does not apply<\/p>\n
– 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;<\/p>\n
– in cases where a maximal SAL of 10-6 is required and an alternative SAL is not allowed;<\/p>\n
– 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;<\/p>\n
– to the sterilization of used or reprocessed health care product;<\/p>\n
– to sterilization of health care product by filtration.<\/p>\n
ISO\/TS 19930:2017 does not describe detailed procedures for assessing microbial inactivation.<\/p>\n
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.<\/p>\n
NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.<\/p>\n
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".<\/p>\n
NOTE These are matters for regulatory authorities and can vary from country to country.<\/p>\n","protected":false},"excerpt":{"rendered":"
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6<\/b><\/p>\n\n\n
\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n ISO<\/b><\/a><\/td>\n 2017-12<\/td>\n 30<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":642912,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-642897","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-iso","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/642897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/642912"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=642897"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=642897"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=642897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}