ISO 8836 Fourth edition 2014-10-15

Standard Organization:

ISO 8836 Fourth edition 2014-10-15
Suction catheters for use in the respiratory tract

Recognition Date2017-08-21
Recognition List047
Recognition Number1-125
Extent Partial recognition. The following part(s) of the standard is (are) not recognized 9.1 Sterility Assurance.
9.2.2 Packaging of suction catheters supplied sterile.
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Anesthesiology
FDA Tech .stds { color: #000000; float: center; width: 950px; margin: 0px 25px 0px 0px; } .stds-middle { color: #000000; float: center; width: 575px; margin: 0px 50px 50px 50px; } /* .stds-left { float: left; margin: 9px 30px 0px 0; } */ .stds-left { color: #000000; float: left; width: 700px; margin: 9px 0px 0px 0px; } .stds-search-left { float: left; width: 610px; margin: 9px 30px 0px 0; } .stds-search-right { float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f9f9f3; border: 1px solid #b0b0b0; -webkit-border-radius: 6px; -moz-border-radius: 6px; border-radius: 6px; } .stds-right { color: #000000; float: right; width: 170px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .stds-intro { margin: 0px 0px 18px 0px; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #stds_nr-form { margin-top: 18px; padding-top: 12px; border-top: 1px dashed #b0b0b0; } #stds-form { table-layout:fixed; width: 700px; font-size: 11px; border: 1px solid #b0b0b0; background-color: #f9f9f3; } #stds-form-title{ padding: 3px 3px 3px 3px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #stds-form-title-left { font-size: 13px; font-weight:normal; } #stds-form-title-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 500px; } #stds-form-results-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 600px; } #stds-search { height: 18px; margin: 0px; padding: 3px 10px; border: 1px solid #b0b0b0; font-size: 12px; color: #484138; } #stds-search:focus, #stds-search:hover { -webkit-box-shadow: 0 0px 6px rgba(0,0,0,.1); -moz-box-shadow: 0 0px 6px rgba(0,0,0,.1); box-shadow: 0 0px 6px rgba(0,0,0,.1); } #stds-results-number { margin-bottom: 12px; font-size: 10px; font-weight: bold; } #stds-results-table { margin-left:auto; margin-right:auto; text-align:left; padding: 0; border-collapse:collapse; table-layout:fixed; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #stds-results-table th { padding: 6px 12px; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #stds-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #stds-results-table tr:nth-child(odd) { /* background-color: #f3f3f3; */ } .sort { float: right; margin: 0px 10px 0px 0px; padding: 0px 5px 5px 5px; } /* .sort { float: right; margin-top: 5px;} */ .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } Recognized Consensus Standards // Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   Recognized Consensus Standards var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: unescape('mp_js_orgin_url'), init: function(){ if (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, getCookie: function(name){ var start=document.cookie.indexOf(name+'='); if(start < 0) return null; start=start+name.length+1; var end=document.cookie.indexOf(';', start); if(end < 0) end=document.cookie.length; while (document.cookie.charAt(start)==' '){ start++; } return unescape(document.cookie.substring(start,end)); }, setCookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new Date(); now.setTime(now.getTime()+1000*60*60*24*365); cookie+='; expires='+now.toUTCString(); document.cookie=cookie; }, switchLanguage: function(lang){ if(lang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); document.body.appendChild(script); } else if(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); document.body.appendChild(script); } return false; }, switchToLang: function(url) { window.top.location.href=url; } }; var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ; FDA Home Medical Devices Databases -

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 8836:2014 specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.

Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of ISO 8836:2014.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§868.6810 Airway Suction Kit Class 1 OFO
§868.6810 Catheters, Suction, Tracheobronchial Class 1 BSY
§868.6810 Non-Bronchoscopic Bronchoalveolar Lavage Catheter Class 1 OYI
§868.6810 Tracheal Suction Set Class 1 OFS
§868.6810 Tracheobronchial Suction Catheter Kit Class 1 OFR

FDA Guidance:

There is no relevant guidance developed at this time.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.