{"id":498617,"date":"2024-11-05T13:10:42","date_gmt":"2024-11-05T13:10:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/as-iso-10993-172004\/"},"modified":"2024-11-05T13:10:42","modified_gmt":"2024-11-05T13:10:42","slug":"as-iso-10993-172004","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/as\/as-iso-10993-172004\/","title":{"rendered":"AS ISO 10993.17:2004"},"content":{"rendered":"<p>Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in\u00a0vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO\u00a010993-17:2002. <\/p>\n<p><b>Scope<\/b><\/p>\n<p> This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. <br \/> This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). <br \/> Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Biological evaluation of medical devices &#8211; Establishment of allowable limits for leachable substances<\/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\/as\/\"><b>AS<\/b><\/a><\/td>\n<td>2004-09-15<\/td>\n<td>36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":498631,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2633],"product_tag":[],"class_list":{"0":"post-498617","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","7":"product_cat-as","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\/498617","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\/498631"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=498617"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=498617"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=498617"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}