{"id":426385,"date":"2024-10-20T07:01:46","date_gmt":"2024-10-20T07:01:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8536-22023-tc\/"},"modified":"2024-10-26T13:17:21","modified_gmt":"2024-10-26T13:17:21","slug":"bs-en-iso-8536-22023-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8536-22023-tc\/","title":{"rendered":"BS EN ISO 8536-2:2023 – TC"},"content":{"rendered":"

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE       The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
30<\/td>\nundefined <\/td>\n<\/tr>\n
32<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
34<\/td>\nForeword <\/td>\n<\/tr>\n
35<\/td>\nIntroduction <\/td>\n<\/tr>\n
37<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
38<\/td>\n4 Shape and dimensions <\/td>\n<\/tr>\n
39<\/td>\n5 Designation
6 Material
7 Requirements
7.1 General
7.2 Physical requirements
7.2.1 Hardness
7.2.2 Fragmentation
7.2.3 Spike penetration force <\/td>\n<\/tr>\n
40<\/td>\n7.2.4 Spike retention\/sealability
7.2.5 Resistance to ageing
7.3 Chemical requirements
7.4 Biological requirements
8 Labelling <\/td>\n<\/tr>\n
41<\/td>\nAnnex A (normative) Determination of fragments <\/td>\n<\/tr>\n
43<\/td>\nAnnex B (normative) Determination of spike penetration force <\/td>\n<\/tr>\n
45<\/td>\nAnnex C (normative) Spike retention\/sealability <\/td>\n<\/tr>\n
47<\/td>\nAnnex D (normative) Closure piercing device <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Infusion equipment for medical use – Closures for infusion bottles<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n52<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":426395,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2641],"product_tag":[],"class_list":{"0":"post-426385","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\/426385","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\/426395"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=426385"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=426385"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=426385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}