| ASTM F1169-13 Standard Consumer Safety Specification for Full-Size Baby Cribs |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 6-339 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Calibration and Standardization. General Requirements - Clause 5.8 Spacing of Crib Components. General Requirements - Clause 5.10 Hardware and Fasteners. General Requirements - Clause 5.17 Scissoring, Shearing, or Pinching. Performance Requirements - Clause 6.2 Cycle Testing. Performance Requirements - Clause 6.3 Crib Side Latch Test Requirements. Performance Requirements - Clause 6.6 Crib Side Test Requirements. Performance Requirements - Clause 6.7 Spindle/Slat Strength Testing. Performance Requirements - Clause 6.10 Mattress Support System Openings. Test Methods - Clause 7.3 Crib Side Latch Test. Test Methods - Clause 7.4 Mattress Support System Vertical Impact Test. Test Methods - Clause 7.5 Mattress Support System Test. Test Methods - Clause 7.6 Crib Side Test. Test Methods - Clause 7.7 Spindle/Slat Static Load Strength Test. Test Methods - Clause 7.8 Component Spacing Test Method. Test Methods - Clause 7.9 Cutout Testing Method. Test Methods - Clause 7.11 Openings. Test Methods - Clause 7.12 Locking Mechanism Test. Markings and Labeling - Clause 8.1.2. Markings and Labeling - Clause 8.1.2.1. Markings and Labeling - Clause 8.1.2.2. Markings and Labeling - Clause 8.1.4. Markings and Labeling - Clause 8.2. Markings and Labeling - Clause 8.3. Markings and Labeling - Clause 8.4.1.3 Fall Hazard. Markings and Labeling - Clause 8.4.1.4. Instructional Literature - 9.1. |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| 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 - |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This consumer safety specification establishes performance requirements and test procedures to determine the structural integrity of full- cribs. It also contains design requirements addressing entanglement on crib corner post extensions, and requirements for warning labels and instructional material. It also covers bassinet, changing table, or similar accessories to a crib that when in the manufacturer's recommended use position are in the occupant retention area. These accessories shall also comply with the applicable requirements of the ASTM International standards addressing those accessories. For example, a changing table that attaches to a crib shall also comply with the applicable requirements in Consumer Safety Specification F2388. This specification does not cover inflatable products.
1.2 No crib produced after the approval date of this consumer safety specification shall, either by label or other means, indicate compliance with this specification unless it conforms to all requirements contained herein.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5140 | Bed, Pediatric Open Hospital | Class 2 | FMS |
| There is no relevant guidance developed at this time. |