{"id":282636,"date":"2024-10-19T19:06:28","date_gmt":"2024-10-19T19:06:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-20-30385404-dc-2020\/"},"modified":"2024-10-25T15:49:47","modified_gmt":"2024-10-25T15:49:47","slug":"bsi-20-30385404-dc-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-20-30385404-dc-2020\/","title":{"rendered":"BSI 20\/30385404 DC 2020"},"content":{"rendered":"

This document specifies requirements and test methods for On-Body Delivery Systems (OBDS), which are body-worn or patient-worn NISs for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.<\/p>\n

\n
\n NOTE 1\n <\/div>\n

Although technically a device using a soft cannula is not \u201cneedle-based\u201d, the soft cannula is placed by a needle and can be included in this classification.<\/p>\n<\/div>\n

\n
\n NOTE 2\n <\/div>\n

Some requirements and methods are already established and included in other parts of the ISO 11608 series<\/span><\/span>. To ensure consistency, these requirements will not be repeated in this document, but referenced.<\/p>\n<\/div>\n

Infusion pumps which are not body or patient worn, or those that are designed for continuous delivery at a specific rate required to achieve and\/or maintain a desired plasma medicinal product concentration, are excluded from this document and may be covered by IEC 60601-2-24<\/span><\/span> (if electronic) or ISO 28620<\/span><\/span> (if non-electronic). However, while this document is not intended to directly apply to these pump products, it does contain requirements and tests methods that can be used to help design and evaluate them.<\/p>\n","protected":false},"excerpt":{"rendered":"

BS ISO 11608-6. Needle-based injection systems for medical use. Requirements and test methods – Part 6. On-body delivery systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n25<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":282640,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-282636","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-25","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\/282636","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\/282640"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=282636"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=282636"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=282636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}