{"id":513432,"date":"2024-11-05T14:24:03","date_gmt":"2024-11-05T14:24:03","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/can-csa-iso-11137-216-r2021\/"},"modified":"2024-11-05T14:24:03","modified_gmt":"2024-11-05T14:24:03","slug":"can-csa-iso-11137-216-r2021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/csa\/can-csa-iso-11137-216-r2021\/","title":{"rendered":"CAN\/CSA-ISO 11137-2:16 (R2021)"},"content":{"rendered":"

Preface<\/strong><\/p>\n

This is the second edition of CAN\/CSA-ISO 11137-2, Sterilization of health care products \u2014 Radiation \u2014 Part 2: Establishing the sterilization dose, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11137-2 (third edition, 2013-06-01). It supersedes the previous edition published in 2007 as CAN\/CSA-Z11137-2 (adopted ISO 11137-2:2006). For brevity, this Standard will be referred to as CAN\/CSA-ISO 11137-2 throughout. <\/p>\n

Scope<\/strong><\/p>\n

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. <\/p>\n

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.<\/p>\n","protected":false},"excerpt":{"rendered":"

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
CSA<\/b><\/a><\/td>\n2016-07-01<\/td>\n91<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":513447,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2674],"product_tag":[],"class_list":{"0":"post-513432","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-csa","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\/513432","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\/513447"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=513432"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=513432"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=513432"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}