{"id":422985,"date":"2024-10-20T06:43:57","date_gmt":"2024-10-20T06:43:57","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-206962018-2\/"},"modified":"2024-10-26T12:37:55","modified_gmt":"2024-10-26T12:37:55","slug":"bs-en-iso-206962018-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-206962018-2\/","title":{"rendered":"BS EN ISO 20696:2018"},"content":{"rendered":"

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.<\/p>\n

This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.<\/p>\n

\n

NOTE Ureteral stents are covered in ASTM F1828\u201197.<\/p>\n<\/blockquote>\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
4<\/td>\nEuropean foreword
Endorsement notice <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
11<\/td>\n4 Intended performance
5 General requirements
5.1 Risk management
5.2 Biocompatibility
5.3 Detectability
5.4 Surface finish
5.5 Size designation
5.5.1 General
5.5.2 Outer diameter <\/td>\n<\/tr>\n
12<\/td>\n5.5.3 Effective shaft lengths <\/td>\n<\/tr>\n
13<\/td>\n5.6 MRI compatibility
5.7 Connector
5.8 Sterilization
6 Specific requirements
6.1 Strength
6.2 Connector security
6.3 Balloon safety
6.4 Catheter inflation lumen integrity and volume maintenance
6.4.1 General <\/td>\n<\/tr>\n
14<\/td>\n6.4.2 Compliant balloon
6.4.3 Non-compliant balloon
6.5 Flow rate <\/td>\n<\/tr>\n
15<\/td>\n6.6 Corrosion resistance
6.7 Kink stability
6.8 Peak tensile force
6.9 Inflated balloon resistance to traction <\/td>\n<\/tr>\n
16<\/td>\n7 Information to be supplied by the manufacturer
7.1 General
7.2 Marking on the device and\/or packaging
7.3 Instructions for use <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (normative) Test method for determining the strength of the catheter <\/td>\n<\/tr>\n
22<\/td>\nAnnex B (normative) Test method for determining the security of fit of the drainage funnel <\/td>\n<\/tr>\n
24<\/td>\nAnnex C (normative) Test method for determining balloon safety <\/td>\n<\/tr>\n
26<\/td>\nAnnex D (normative) Test method for determining inflation lumen leakage and\/or function and\/or balloon deflation (catheter with compliant balloon) <\/td>\n<\/tr>\n
28<\/td>\nAnnex E (normative) Test method for determination of flow rate through catheter <\/td>\n<\/tr>\n
30<\/td>\nAnnex F (normative) Test method for corrosion resistance <\/td>\n<\/tr>\n
31<\/td>\nAnnex G (informative) Test method for determining kink stability <\/td>\n<\/tr>\n
33<\/td>\nAnnex H (normative) Test method for determining peak tensile force of urethral catheter <\/td>\n<\/tr>\n
35<\/td>\nAnnex I (normative) Test method for determining balloon size deflation reliability (catheter with non-compliant balloon) <\/td>\n<\/tr>\n
37<\/td>\nAnnex J (normative) Test method for determining inflated balloon resistance to traction <\/td>\n<\/tr>\n
41<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterile urethral catheters for single use<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n42<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":422995,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-422985","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\/422985","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\/422995"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=422985"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=422985"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=422985"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}