{"id":446056,"date":"2024-10-20T08:44:51","date_gmt":"2024-10-20T08:44:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10555-12023\/"},"modified":"2024-10-26T16:17:42","modified_gmt":"2024-10-26T16:17:42","slug":"bs-en-iso-10555-12023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10555-12023\/","title":{"rendered":"BS EN ISO 10555-1:2023"},"content":{"rendered":"

This document specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. This document does not apply to intravascular catheter accessories, e.g. those covered by ISO 11070.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\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
7<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Requirements
4.1 Risk approach
4.2 Usability engineering
4.3 Sterilization
4.4 Shelf life
4.5 Detectability
4.6 Biocompatibility
4.7 Surface <\/td>\n<\/tr>\n
14<\/td>\n4.8 Corrosion resistance
4.9 Peak tensile force <\/td>\n<\/tr>\n
15<\/td>\n4.10 Freedom from leakage during pressurization
4.11 Freedom from leakage during aspiration
4.12 Hubs <\/td>\n<\/tr>\n
16<\/td>\n4.13 Flowrate
4.14 Power injection burst pressure
4.15 Packaging system
4.16 Simulated use, kink and\/or torque testing to consider depending on device design, intended use, and risk analysis <\/td>\n<\/tr>\n
17<\/td>\n4.17 Coating integrity and\/or particulate testing to consider depending on device design, intended use, and risk analysis
4.18 Distal tip stiffness testing to consider for neurovascular applications
5 Designation of nominal size
5.1 Nominal outside diameter
5.2 Nominal inside diameter
5.3 Nominal effective length <\/td>\n<\/tr>\n
18<\/td>\n6 Information to be supplied with the catheter
6.1 General
6.2 Marking on the device and\/or primary packaging <\/td>\n<\/tr>\n
19<\/td>\n6.3 Instructions for use
6.4 Marking on the secondary packaging <\/td>\n<\/tr>\n
20<\/td>\nAnnex A (normative) Test method for corrosion resistance <\/td>\n<\/tr>\n
21<\/td>\nAnnex B (normative) Method for determining peak tensile force <\/td>\n<\/tr>\n
24<\/td>\nAnnex C (normative) Test method for liquid leakage under pressure <\/td>\n<\/tr>\n
26<\/td>\nAnnex D (normative) Test method for air leakage into hub assembly during aspiration <\/td>\n<\/tr>\n
28<\/td>\nAnnex E (normative) Determination of flowrate through catheter <\/td>\n<\/tr>\n
30<\/td>\nAnnex F (normative) Test for burst pressure under static conditions <\/td>\n<\/tr>\n
33<\/td>\nAnnex G (normative) Power injection tests for flowrate and device pressure (only for products indicated for power injection) <\/td>\n<\/tr>\n
38<\/td>\nAnnex H (informative) Units of measurement systems other than those specified in this document <\/td>\n<\/tr>\n
40<\/td>\nAnnex I (normative) Test method for air leakage under water <\/td>\n<\/tr>\n
42<\/td>\nAnnex J (informative) Rationale and guidance <\/td>\n<\/tr>\n
49<\/td>\nAnnex K (informative) Test methods for distal tip stiffness for neurovascular applications <\/td>\n<\/tr>\n
51<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Intravascular catheters. Sterile and single-use catheters – General requirements<\/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":446067,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-446056","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\/446056","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\/446067"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=446056"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=446056"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=446056"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}