{"id":541346,"date":"2024-11-05T16:51:23","date_gmt":"2024-11-05T16:51:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/din-en-iso-11137-1\/"},"modified":"2024-11-05T16:51:23","modified_gmt":"2024-11-05T16:51:23","slug":"din-en-iso-11137-1","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/din\/din-en-iso-11137-1\/","title":{"rendered":"DIN EN ISO 11137-1"},"content":{"rendered":"<p>ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not:specify requirements for 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; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Sterilization of health care products &#8211; Radiation &#8211; Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/din\/\"><b>DIN<\/b><\/a><\/td>\n<td>2020-04<\/td>\n<td>63<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":541358,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[158,2635],"product_tag":[],"class_list":{"0":"post-541346","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-99","7":"product_cat-din","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\/541346","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\/541358"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=541346"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=541346"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=541346"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}