{"id":279097,"date":"2024-10-19T18:49:25","date_gmt":"2024-10-19T18:49:25","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-556-12001\/"},"modified":"2024-10-25T15:23:10","modified_gmt":"2024-10-25T15:23:10","slug":"bs-en-556-12001","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-556-12001\/","title":{"rendered":"BS EN 556-1:2001"},"content":{"rendered":"<p>This European Standard specifies the requirements for a terminally-sterilized <i>medical device<\/i> to be designated &#8220;<i>STERILE<\/i>&#8220;. Part&nbsp;2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated &#8220;<i>STERILE<\/i>&#8220;.<\/p>\n<blockquote>\n<p>NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as <i>&#8220;STERILE&#8221;<\/i> is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of <i>medical devices<\/i> are specified in EN&nbsp;550 , EN&nbsp;552 , EN&nbsp;554 , EN ISO&nbsp;14160 and EN ISO&nbsp;14937.<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p><b>Sterilization of medical devices. Requirements for medical devices to be designated &#8220;STERILE&#8221; &#8211; Part 1. Requirements for terminally sterilized medical devices<\/b><\/p>\n<table class=\"shortdes-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\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2006<\/td>\n<td>12<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279099,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-279097","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","7":"product_cat-bsi","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\/279097","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\/279099"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279097"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279097"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279097"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}