{"id":375322,"date":"2024-10-20T02:43:03","date_gmt":"2024-10-20T02:43:03","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80369-72021\/"},"modified":"2024-10-26T04:45:17","modified_gmt":"2024-10-26T04:45:17","slug":"bs-en-iso-80369-72021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80369-72021\/","title":{"rendered":"BS EN ISO 80369-7:2021"},"content":{"rendered":"

This document specifies dimensions and requirements for the design and functional performance of small-bore connectors<\/i> intended to be used for connections<\/i> in intravascular applications<\/i> or hypodermic connections<\/i> in hypodermic applications<\/i> of medical devices<\/i> and accessories<\/i>.<\/p>\n

\n
\n EXAMPLES\n <\/div>\n

Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors<\/i> and Luer lock connectors<\/i>.<\/p>\n<\/div>\n

\n
\n NOTE 1\n <\/div>\n

See Annex A<\/span>.<\/p>\n<\/div>\n

\n
\n NOTE 2\n <\/div>\n

The Luer connector<\/i> was originally designed for use at pressures up to 300 kPa.<\/p>\n<\/div>\n

This document does not specify requirements for the medical devices<\/i> or accessories<\/i> that use these connectors<\/i>. Such requirements are given in particular documents for specific medical devices<\/i> or accessories<\/i>.<\/p>\n

This document does not specify requirements for the following small-bore connectors,<\/i> which are specified in other documents:<\/p>\n

    \n
  1. \n

    haemodialyser, haemodiafilter and haemofilter blood compartment ports ( ISO 8637<\/span><\/span> [<\/sup> 5<\/sup><\/span> ]<\/sup> and applicable portion of ISO 8638<\/span><\/span> [<\/sup> 6<\/sup><\/span> ]<\/sup> referencing blood compartment ports);<\/p>\n<\/li>\n

  2. \n

    haemodialysis, haemodiafiltration and haemofiltration equipment connectors<\/i> ( ISO 8637<\/span><\/span> [<\/sup> 5<\/sup><\/span> ]<\/sup>);<\/p>\n<\/li>\n

  3. \n

    infusion system closure piercing connectors<\/i> ( ISO 8536-4<\/span><\/span> [<\/sup> 4<\/sup><\/span> ]<\/sup>).<\/p>\n<\/li>\n<\/ol>\n

    \n
    \n NOTE 3\n <\/div>\n

    Manufacturers<\/i> are encouraged to incorporate the small-bore connectors<\/i> specified in this document into medical devices<\/i> or accessories<\/i>, even if currently not required by the relevant particular medical device<\/i> documents. It is expected that when the relevant particular medical device<\/i> documents are revised, requirements for small-bore connectors<\/i>, as specified in ISO 80369<\/span><\/span> , will be included.<\/p>\n<\/div>\n

    \n
    \n NOTE 4\n <\/div>\n

    ISO 80369-1:2018<\/span>, Clause 7<\/span>, specifies alternative methods of conformance with ISO 80369-1:2018<\/span><\/span> , for small-bore connectors<\/i> intended for use with intravascular applications<\/i> or hypodermic application medical devices<\/i> or accessories<\/i>, which do not conform with this document.<\/p>\n<\/div>\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
    PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
    2<\/td>\nundefined <\/td>\n<\/tr>\n
    6<\/td>\nForeword <\/td>\n<\/tr>\n
    7<\/td>\nIntroduction <\/td>\n<\/tr>\n
    9<\/td>\n1 Scope
    2 Normative references <\/td>\n<\/tr>\n
    10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
    11<\/td>\n4 General requirements
    4.1 General requirements for Luer connectors
    4.2 Type tests
    5 Dimensional requirements for Luer connectors <\/td>\n<\/tr>\n
    12<\/td>\n6 Performance requirements
    6.1 Fluid leakage
    6.1.1 Fluid leakage requirement
    6.1.2 Leakage by pressure decay
    6.1.3 Positive pressure liquid leakage
    6.2 Sub-atmospheric pressure air leakage <\/td>\n<\/tr>\n
    13<\/td>\n6.3 Stress cracking
    6.4 Resistance to separation from axial load
    6.5 Resistance to separation from unscrewing
    6.6 Resistance to overriding <\/td>\n<\/tr>\n
    14<\/td>\nAnnex A (informative) Rationale and guidance <\/td>\n<\/tr>\n
    18<\/td>\nAnnex B (normative) Luer connectors <\/td>\n<\/tr>\n
    33<\/td>\nAnnex C (normative) Reference connectors <\/td>\n<\/tr>\n
    40<\/td>\nAnnex D (informative) Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n
    42<\/td>\nAnnex E (informative) Summary of the usability requirements for Luer connectors for intravascular or hypodermic applications <\/td>\n<\/tr>\n
    46<\/td>\nAnnex F (informative) Summary of Luer connector design requirements for intravascular or hypodermic applications <\/td>\n<\/tr>\n
    49<\/td>\nAnnex G (informative) Summary of assessment of the design of the Luer connector for intravascular or hypodermic applications <\/td>\n<\/tr>\n
    52<\/td>\nAnnex H (informative) Reference to the essential principles <\/td>\n<\/tr>\n
    53<\/td>\nAnnex I (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n
    54<\/td>\nAnnex J (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
    55<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Small-bore connectors for liquids and gases in healthcare applications – Connectors for intravascular or hypodermic applications<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2021<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":375332,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-375322","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\/375322","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\/375332"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=375322"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=375322"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=375322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}