{"id":464715,"date":"2024-10-20T10:36:28","date_gmt":"2024-10-20T10:36:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-18250-12018\/"},"modified":"2024-10-26T19:33:16","modified_gmt":"2024-10-26T19:33:16","slug":"bs-iso-18250-12018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-18250-12018\/","title":{"rendered":"BS ISO 18250-1:2018"},"content":{"rendered":"<p>This document specifies general requirements for <small style=\"text-transform: uppercase\">reservoir connectors<\/small>, which convey fluids in healthcare <small style=\"text-transform: uppercase\">applications<\/small>. These <small style=\"text-transform: uppercase\">reservoir connectors<\/small> are used in <small style=\"text-transform: uppercase\">medical devices<\/small> or <small style=\"text-transform: uppercase\">accessories<\/small> intended for use with a <small style=\"text-transform: uppercase\">patient<\/small>.<\/p>\n<p>This document also specifies the healthcare fields in which these <small style=\"text-transform: uppercase\">reservoir connectors<\/small> are intended to be used.<\/p>\n<p>These healthcare fields of use include, but are not limited to, <small style=\"text-transform: uppercase\">applications<\/small> for<\/p>\n<ul>\n<li>\n<p>respiratory,<\/p>\n<\/li>\n<li>\n<p>enteral,<\/p>\n<\/li>\n<li>\n<p>neural,<\/p>\n<\/li>\n<li>\n<p>intravascular,<\/p>\n<\/li>\n<li>\n<p>citrate-based anticoagulant solution, and<\/p>\n<\/li>\n<li>\n<p>irrigation.<\/p>\n<\/li>\n<\/ul>\n<p><small style=\"text-transform: uppercase\">Reservoir connectors<\/small> as specified in this document are <small style=\"text-transform: uppercase\">non-interconnectable<\/small> with:<\/p>\n<ul>\n<li>\n<p>the <small style=\"text-transform: uppercase\">reservoir connectors<\/small> of every other <small style=\"text-transform: uppercase\">application<\/small> specified in the ISO&nbsp;18250 series;<\/p>\n<\/li>\n<li>\n<p>removable temperature sensor port specified in Annex&nbsp;EE of ISO&nbsp;80601\u20112\u201174:2017;<\/p>\n<\/li>\n<li>\n<p>the nipples specified in Annex&nbsp;B of ISO&nbsp;17256<sup>1<\/sup>;<\/p>\n<\/li>\n<\/ul>\n<p>unless otherwise specified in the ISO&nbsp;18250 series.<\/p>\n<p><small style=\"text-transform: uppercase\">Application<\/small> parts of the ISO&nbsp;18250 series can specify additional <small style=\"text-transform: uppercase\">connectors<\/small> with which <small style=\"text-transform: uppercase\">reservoir connectors<\/small> (as specified in those <small style=\"text-transform: uppercase\">application<\/small> parts) are to be <small style=\"text-transform: uppercase\">non-interconnectable<\/small>.<\/p>\n<p>This document provides the methodology to assess <small style=\"text-transform: uppercase\">non-interconnectable<\/small> characteristics of <small style=\"text-transform: uppercase\">reservoir connectors<\/small> based on their inherent design and dimensions in order to reduce the <small style=\"text-transform: uppercase\">risk<\/small> of <small style=\"text-transform: uppercase\">misconnections<\/small> between <small style=\"text-transform: uppercase\">medical devices<\/small> or between <small style=\"text-transform: uppercase\">accessories<\/small> for different <small style=\"text-transform: uppercase\">applications<\/small>.<\/p>\n<p>This document does not specify requirements for the <small style=\"text-transform: uppercase\">medical devices<\/small> or <small style=\"text-transform: uppercase\">accessories<\/small> that use these <small style=\"text-transform: uppercase\">reservoir connectors<\/small>. Such requirements are given in particular International Standards for specific <small style=\"text-transform: uppercase\">medical devices<\/small> or <small style=\"text-transform: uppercase\">accessories<\/small>.<\/p>\n<blockquote>\n<p>NOTE&nbsp;1 <small style=\"text-transform: uppercase\">Manufacturers<\/small> are encouraged to incorporate the <small style=\"text-transform: uppercase\">reservoir connectors<\/small> specified in the ISO&nbsp;18250 series into <small style=\"text-transform: uppercase\">medical devices<\/small>, medical systems or <small style=\"text-transform: uppercase\">accessories<\/small>, even if currently not required by the relevant particular <small style=\"text-transform: uppercase\">medical device<\/small> standards. It is expected that when the relevant particular <small style=\"text-transform: uppercase\">medical device<\/small> standards are revised, requirements for <small style=\"text-transform: uppercase\">reservoir connectors<\/small> as specified in the series of standards will be included.<\/p>\n<\/blockquote>\n<blockquote>\n<p>NOTE&nbsp;2 The ISO&nbsp;18250 series does not apply to screw and crown cork caps and necks as they are not <small style=\"text-transform: uppercase\">connectors<\/small> specific for <small style=\"text-transform: uppercase\">medical devices<\/small>. Examples of screw caps and necks are defined in DIN&nbsp;55525, ASTM&nbsp;D2911\/D2911M, DIN&nbsp;6063\u20111, DIN&nbsp;6063\u20112, DIN&nbsp;168\u20111. Examples of crown cork caps and necks are defined in DIN&nbsp;6094,&nbsp;ISO&nbsp;12821, EN&nbsp;14635.<\/p>\n<\/blockquote>\n<p>This document also specifies the <small style=\"text-transform: uppercase\">test methods<\/small> to verify the common performance requirements for <small style=\"text-transform: uppercase\">reservoir connectors.<\/small> The performance requirements for these common <small style=\"text-transform: uppercase\">test methods<\/small> are specified in the <small style=\"text-transform: uppercase\">application<\/small> parts and not in the general part.<\/p>\n<p><sup>1<\/sup> Under preparation. Stage at the time of publication: ISO\/DIS 17256:2017.<\/p>\n<h4>PDF Catalog<\/h4>\n<table border=\"1px\" class=\"des-table\">\n<tr>\n<th>PDF Pages<\/th>\n<th>PDF Title<\/th>\n<\/tr>\n<tr>\n<td><b>2<b><\/td>\n<td>National foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>6<b><\/td>\n<td>Foreword  <\/td>\n<\/tr>\n<tr>\n<td><b>8<b><\/td>\n<td>Introduction  <\/td>\n<\/tr>\n<tr>\n<td><b>9<b><\/td>\n<td>1 *Scope  <\/td>\n<\/tr>\n<tr>\n<td><b>10<b><\/td>\n<td>2 Normative references <br \/> 3 Terms and definitions  <\/td>\n<\/tr>\n<tr>\n<td><b>12<b><\/td>\n<td>4 Materials used for reservoir connectors <br \/> 4.1 *General <br \/> 4.2 Alternative test methods <br \/> 5 *Requirements for reservoir connectors for specific applications <br \/> 5.1 *Reservoir connector incompatibility  <\/td>\n<\/tr>\n<tr>\n<td><b>13<b><\/td>\n<td>5.2 Enteral applications <br \/> 5.3 Neural applications <br \/> 5.4 Intravascular applications <br \/> 5.5 Citrate-based anticoagulant solution for apheresis applications <br \/> 6 *reservoir connectors for applications not already covered in the ISO 18250 series <br \/> 7 *Performance requirements <br \/> 7.1 Leakage <br \/> 7.1.1 Positive-pressure liquid leakage  <\/td>\n<\/tr>\n<tr>\n<td><b>14<b><\/td>\n<td>7.1.2 Sub atmospheric pressure air leakage <br \/> 7.2 Stress-cracking <br \/> 7.3 Resistance to separation from axial load <br \/> 7.4 Resistance to separation from unscrewing <br \/> 7.5 Resistance to overriding <br \/> 7.6 Disconnection by unscrewing for floating or rotating screw\u2010thread locking connectors and locking connectors with fixed threads  <\/td>\n<\/tr>\n<tr>\n<td><b>15<b><\/td>\n<td>Annex A (informative) Rationale and guidance  <\/td>\n<\/tr>\n<tr>\n<td><b>22<b><\/td>\n<td>Annex B (normative) test methods for demonstrating non-interconnectable characteristics  <\/td>\n<\/tr>\n<tr>\n<td><b>36<b><\/td>\n<td>Annex C (normative) *Positive pressure liquid leakage test method  <\/td>\n<\/tr>\n<tr>\n<td><b>39<b><\/td>\n<td>Annex D (normative) *Sub-atmospheric-pressure air leakage test method  <\/td>\n<\/tr>\n<tr>\n<td><b>43<b><\/td>\n<td>Annex E (normative) *Stress cracking test method  <\/td>\n<\/tr>\n<tr>\n<td><b>45<b><\/td>\n<td>Annex F (normative) *Resistance to separation from axial load test method  <\/td>\n<\/tr>\n<tr>\n<td><b>47<b><\/td>\n<td>Annex G (normative) *Resistance to separation from unscrewing test method  <\/td>\n<\/tr>\n<tr>\n<td><b>49<b><\/td>\n<td>Annex H (normative) *Resistance to overriding test method  <\/td>\n<\/tr>\n<tr>\n<td><b>51<b><\/td>\n<td>Annex I (normative) *Disconnection by unscrewing test method for floating or rotating screw-thread locking connectors and locking connectors with fixed threads  <\/td>\n<\/tr>\n<tr>\n<td><b>53<b><\/td>\n<td>Annex J (informative) *Modification of the test methods to generate variable data for statistical analysis  <\/td>\n<\/tr>\n<tr>\n<td><b>56<b><\/td>\n<td>Annex K (informative) Examples of medical devices on which reservoir connectors may be used for each application category  <\/td>\n<\/tr>\n<tr>\n<td><b>57<b><\/td>\n<td>Annex L (informative) Alternative mechanical test methods  <\/td>\n<\/tr>\n<tr>\n<td><b>58<b><\/td>\n<td>Bibliography  <\/td>\n<\/tr>\n<tr>\n<td><b>59<b><\/td>\n<td>Terminology \u2014 Alphabetical index of defined terms  <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices. Connectors for reservoir delivery systems for healthcare applications &#8211; General requirements and common test methods<\/b><\/p>\n<table class=\"shortdes-table\" style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/bsi\/\"><b>BSI<\/b><\/a><\/td>\n<td>2018<\/td>\n<td>62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464725,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-464715","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\/464715","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\/464725"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464715"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464715"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464715"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}