{"id":408118,"date":"2024-10-20T05:29:05","date_gmt":"2024-10-20T05:29:05","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80369-62016\/"},"modified":"2024-10-26T09:58:03","modified_gmt":"2024-10-26T09:58:03","slug":"bs-en-iso-80369-62016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80369-62016\/","title":{"rendered":"BS EN ISO 80369-6:2016"},"content":{"rendered":"

This part of ISO 80369 specifies requirements for small-bore connectors<\/small> intended to be used for connections<\/small> in neuraxial applications<\/small>. Neuraxial applications<\/small> involve the use of medical devices<\/small> intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.<\/p>\n

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NOTE 1 Sites for the neuraxial application<\/small> include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application<\/small> anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application<\/small> procedures include continuous infusion of wounds with local anaesthetic agents.<\/p>\n<\/blockquote>\n

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NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application<\/small>.<\/p>\n<\/blockquote>\n

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EXAMPLES<\/b> Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.<\/p>\n<\/blockquote>\n

This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors<\/small> intended to be used with medical devices<\/small>.<\/p>\n

This part of ISO 80369 does not specify requirements for the medical devices<\/small> or accessories<\/small> that use these connectors<\/small>. Such requirements are given in particular International Standards for specific medical devices<\/small> or accessories<\/small>.<\/p>\n

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NOTE 3 Manufacturers<\/small> are encouraged to incorporate the small-bore connectors<\/small> specified in this part of ISO 80369 into medical devices<\/small>, medical systems, or accessories<\/small>, even if currently not required by the relevant particular medical device<\/small> standards. It is expected that when the relevant particular medical device<\/small> standards are revised, requirements for small-bore connectors<\/small>, as specified in this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices<\/small> used for neuraxial applications<\/small>.<\/p>\n<\/blockquote>\n

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NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors<\/small> intended for use with neuraxial application medical devices<\/small> or accessories<\/small>, which do not comply with this part of ISO 80369.<\/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
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nTable \u2014 Correlation between normative references and dated EN and ISO standards
Endorsement notice <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC
Table ZA.1 \u2014 Correspondence between this document and Directive 93\/42\/EEC <\/td>\n<\/tr>\n
7<\/td>\nTable ZA.2 \u2014 Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006\/42\/EC on machinery that are addressed by this document <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 *\u00a0Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 General requirements
4.1 General requirements for the neuraxial application <\/td>\n<\/tr>\n
16<\/td>\n4.2 *\u00a0Material used for small-bore connectors
4.3 \u200bType tests
5 Dimensional requirements for neuraxial small-bore connectors
6 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 <\/td>\n<\/tr>\n
17<\/td>\n6.2 Subatmospheric pressure air leakage
6.3 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
18<\/td>\nAnnex\u00a0A (informative) Rationale and guidance <\/td>\n<\/tr>\n
23<\/td>\nAnnex\u00a0B (normative) *\u00a0Small-bore connectors for neuraxial applications <\/td>\n<\/tr>\n
32<\/td>\nAnnex\u00a0C (normative) Reference connectors for testing small-bore connectors for neuraxial applications <\/td>\n<\/tr>\n
38<\/td>\nAnnex\u00a0D (informative) Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n
39<\/td>\nAnnex\u00a0E (informative) Summary of the usability requirements for small-bore connectors for neuraxial applications <\/td>\n<\/tr>\n
42<\/td>\nAnnex\u00a0F (informative) Summary of small-bore connector design requirements for neuraxial applications <\/td>\n<\/tr>\n
45<\/td>\nAnnex\u00a0G (informative) Summary of assessment of the design of the small bore connectors for neuraxial applications <\/td>\n<\/tr>\n
49<\/td>\nAnnex\u00a0H (normative) Mechanical tests for verifying non-interconnectable characteristics <\/td>\n<\/tr>\n
53<\/td>\nAnnex\u00a0I (informative) Reference to the essential principles <\/td>\n<\/tr>\n
55<\/td>\nAnnex\u00a0J (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n
56<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Small bore connectors for liquids and gases in healthcare applications – Connectors for neuraxial 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>\n2017<\/td>\n60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":408126,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-408118","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\/408118","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\/408126"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=408118"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=408118"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=408118"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}