ISO 80369-3 First Edition 2016-07-01

Standard Organization:

ISO 80369-3 First Edition 2016-07-01
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications.

Recognition Date2016-09-21
Recognition List045
Recognition Number5-109
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG General I (QS/RM)
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 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.

NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.

It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

It does not specify requirements for small-bore connectors that are used for the following:

- gastric suction-only medical devices;

- oral-only medical devices;

EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.

- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;

- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;

- gastrointestinal endoscopy equipment;

- skin level gastrostomy medical devices.

NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§876.5980 Enteral Specific Transition Connectors Class 2 PIO
§876.5980 Enteral Syringes With Enteral Specific Connectors Class 2 PNR
§876.5980 Gastrointestinal Tubes With Enteral Specific Connectors Class 2 PIF
§876.5980 Set, Gavage, Infant, Sterile Class 2 FHT
§876.5980 String And Tubes, Gastrointestinal, To Locate Internal Bleeding Class 2 FFW
§876.5980 Tube, Feeding Class 2 FPD
§876.5980 Tube, Gastro-Enterostomy Class 2 KGC
§876.5980 Tube, Nasogastric Class 2 BSS
§876.5980 Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression Class 2 FEF
§876.5980 Tubes, Gastrointestinal (And Accessories) Class 2 KNT

FDA Guidance:

Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, Issued on February 11, 2015

(Website) Information for Manufacturers of Small-Bore Connectors and Medical Devices with Connectors
http://www.fda.gov/medicaldevices/safety/alertsandnotices/tubingandluermisconnections/ucm313322.htm

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