IEEE Std 11073-10417-2015

Standard Organization:

IEEE Std 11073-10417-2015
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter

Recognition Date2017-08-21
Recognition List047
Recognition Number13-90
Extent Complete standard
Standards Orgs IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
STG Software/Informatics
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:

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication between personal telehealth glucose meter devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) is established by this standard in a manner that enables plug-and play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability are specified. A common core of communication functionality for personal telehealth glucose meters is defined in this standard.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§862.1345 Glucose Dehydrogenase, Glucose Class 2 LFR
§862.1345 Glucose Oxidase, Glucose Class 2 CGA
§862.1345 Hexokinase, Glucose Class 2 CFR
§862.1345 System, Test, Blood Glucose, Over The Counter Class 2 NBW
Unclassified Automated Insulin Dosing , Threshold Suspend Class 3 OZO
Unclassified Automated Insulin Dosing Device System, Single Hormonal Control Class 3 OZP
Unclassified Sensor, Glucose, Invasive Class 3 MDS

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.