{"id":446057,"date":"2024-10-20T08:44:51","date_gmt":"2024-10-20T08:44:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10555-42023\/"},"modified":"2024-10-26T16:17:44","modified_gmt":"2024-10-26T16:17:44","slug":"bs-en-iso-10555-42023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10555-42023\/","title":{"rendered":"BS EN ISO 10555-4:2023"},"content":{"rendered":"

This document specifies requirements for balloon dilatation catheters supplied sterile and intended for single use. This document does not specify requirements for vascular stents (see ISO 25539-2). NOTE            Guidance on the selection of balloon materials is given in Annex G.<\/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
2<\/td>\nundefined <\/td>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Requirements
4.1 General
4.2 Detectability of the balloon position
4.3 Designation of nominal size
4.4 Physical requirements
4.4.1 Balloon rated burst pressure (RBP)
4.4.2 Balloon fatigue; freedom from leakage and damage on inflation
4.4.3 Balloon deflation time
4.4.4 Balloon diameter to inflation pressure (balloon compliance) <\/td>\n<\/tr>\n
11<\/td>\n4.4.5 Crossing profile
4.4.6 Balloon removal
4.5 Information to be supplied with the catheter <\/td>\n<\/tr>\n
12<\/td>\nAnnex A (normative) Test for rated burst pressure (RBP) <\/td>\n<\/tr>\n
14<\/td>\nAnnex B (normative) Balloon fatigue test for freedom from leakage and damage on inflation <\/td>\n<\/tr>\n
16<\/td>\nAnnex C (normative) Test for balloon deflation time <\/td>\n<\/tr>\n
18<\/td>\nAnnex D (normative) Test for balloon diameter to inflation pressure (balloon compliance) <\/td>\n<\/tr>\n
20<\/td>\nAnnex E (normative) Determination of crossing profile <\/td>\n<\/tr>\n
22<\/td>\nAnnex F (normative) Test method for balloon removal <\/td>\n<\/tr>\n
24<\/td>\nAnnex G (informative) Rationale and guidance <\/td>\n<\/tr>\n
25<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Intravascular catheters. Sterile and single-use catheters – Balloon dilatation catheters<\/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>\n26<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":446065,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-446057","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\/446057","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\/446065"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=446057"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=446057"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=446057"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}