{"id":408128,"date":"2024-10-20T05:29:08","date_gmt":"2024-10-20T05:29:08","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-157472019\/"},"modified":"2024-10-26T09:58:06","modified_gmt":"2024-10-26T09:58:06","slug":"bs-en-iso-157472019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-157472019\/","title":{"rendered":"BS EN ISO 15747:2019"},"content":{"rendered":"<p>This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.<\/p>\n<p>This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50&nbsp;ml to 5&nbsp;000&nbsp;ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.<\/p>\n<blockquote>\n<p>NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.<\/p>\n<\/blockquote>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>4<b><\/td>\n<td>European foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>5<b><\/td>\n<td>Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 Scope <br \/> 2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>4 Requirements <br \/> 4.1 Physical requirements <br \/> 4.1.1 Manufacturing process compatibility  <\/td>\n<\/tr>\n<tr>\n<td><b>11<b><\/td>\n<td>4.1.2 Resistance to temperature, pressure and leakage <br \/> 4.1.3 Resistance to dropping <br \/> 4.1.4 Transparency <br \/> 4.1.5 Water vapour permeability <br \/> 4.1.6 Particulate contamination <br \/> 4.1.7 Cover <br \/> 4.1.8 Access port \u2014 Penetration ability of the insertion point <br \/> 4.1.9 Access port \u2014 Adhesion strength of the infusion device and impermeability of the insertion point  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>4.1.10 Access port \u2014 Tightness of the injection point <br \/> 4.1.11 Hanger <br \/> 4.1.12 Identification <br \/> 4.2 Chemical requirements <br \/> 4.2.1 Requirements for the raw container or the sheeting <br \/> 4.2.2 Requirements for the test fluid  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>4.3 Biological requirements <br \/> 4.3.1 Impermeability for microorganisms <br \/> 4.3.2 Migration <br \/> 5 Application of tests  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>Annex A (normative) Physical tests  <\/td>\n<\/tr>\n<tr>\n<td><b>17<b><\/td>\n<td>Annex B (normative) Chemical tests  <\/td>\n<\/tr>\n<tr>\n<td><b>20<b><\/td>\n<td>Annex C (normative) Biological tests  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>Annex D (normative) Reference spike  <\/td>\n<\/tr>\n<tr>\n<td><b>24<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Plastic containers for intravenous injections<\/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>2019<\/td>\n<td>26<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408136,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2641],"product_tag":[],"class_list":{"0":"post-408128","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-20","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\/408128","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\/408136"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408128"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408128"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}