{"id":641893,"date":"2024-11-06T01:25:48","date_gmt":"2024-11-06T01:25:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/iso-ts-134092002\/"},"modified":"2024-11-06T01:25:48","modified_gmt":"2024-11-06T01:25:48","slug":"iso-ts-134092002","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/iso\/iso-ts-134092002\/","title":{"rendered":"ISO\/TS 13409:2002"},"content":{"rendered":"

ISO\/TS 13409:2002 describes a method of substantiating the suitability of 25 kGy as a sterilization dose for radiation sterilization of products with an average bioburden of less than 1 000 colony-forming units (cfu) that are manufactured in small quantities (less than 1 000 product units).<\/p>\n

This method may be used to substantiate a sterilization dose of 25 kGy for any of the following situations:<\/p>\n

    \n
  1. a single batch of product units;<\/li>\n
  2. initial production of a new product while the sterilization dose is being established by another method;<\/li>\n
  3. routine production of small batches.<\/li>\n<\/ol>\n

    Information collected in applying the method of dose substantiation described in this Technical Specification may be applicable in meeting the product qualification requirements for sterilization dose selection of ISO 11137:1995.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Sterilization of health care products \u2014 Radiation sterilization \u2014 Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    ISO<\/b><\/a><\/td>\n2002-09<\/td>\n20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":641908,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2634],"product_tag":[],"class_list":{"0":"post-641893","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\/641893","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\/641908"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=641893"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=641893"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=641893"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}