{"id":282604,"date":"2024-10-19T19:06:20","date_gmt":"2024-10-19T19:06:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-20-30382352-dc-2020\/"},"modified":"2024-10-25T15:49:31","modified_gmt":"2024-10-25T15:49:31","slug":"bsi-20-30382352-dc-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-20-30382352-dc-2020\/","title":{"rendered":"BSI 20\/30382352 DC 2020"},"content":{"rendered":"
This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1<\/span><\/span> (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.<\/p>\n Prefilled syringes (ISO 11040-8<\/span><\/span>) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx<\/span><\/span>.<\/p>\n<\/div>\n Products excluded from scope are:<\/p>\n sterile hypodermic needles for single use;<\/p>\n<\/li>\n sterile hypodermic syringes for single use;<\/p>\n<\/li>\n sterile single-use syringes, with or without needle, for insulin;<\/p>\n<\/li>\n containers that can be refilled multiple times;<\/p>\n<\/li>\n containers intended for dental use;<\/p>\n<\/li>\n catheters or infusion sets that are attached or assembled separately by the user.<\/p>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":" BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods – Part 3. NIS containers and integrated fluid paths<\/b><\/p>\n\n
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\n Published By<\/td>\n Publication Date<\/td>\n Number of Pages<\/td>\n<\/tr>\n \n BSI<\/b><\/a><\/td>\n 2020<\/td>\n 34<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":282612,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-282604","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\/282604","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\/282612"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=282604"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=282604"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=282604"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}