{"id":281618,"date":"2024-10-19T19:01:46","date_gmt":"2024-10-19T19:01:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-216492009\/"},"modified":"2024-10-25T15:41:08","modified_gmt":"2024-10-25T15:41:08","slug":"bs-en-iso-216492009","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-216492009\/","title":{"rendered":"BS EN ISO 21649:2009"},"content":{"rendered":"<p>This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.<\/p>\n<p>The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a \u201ccartridge\u201d, \u201campoule\u201d, \u201csyringe\u201d, \u201ccapsule\u201d or \u201cdisc\u201d. In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device.<\/p>\n<p>Excluded from this International Standard are drug delivery methods which:<\/p>\n<ul>\n<li>\n<p>involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);<\/p>\n<\/li>\n<li>\n<p>generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);<\/p>\n<\/li>\n<li>\n<p>deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);<\/p>\n<\/li>\n<li>\n<p>apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);<\/p>\n<\/li>\n<li>\n<p>infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and\/or needles which themselves enter the body.<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p><b>Needle-free injectors for medical use. Requirements and test methods<\/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>2009<\/td>\n<td>44<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":281621,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2641],"product_tag":[],"class_list":{"0":"post-281618","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\/281618","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\/281621"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=281618"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=281618"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=281618"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}