SAE AMS7461 Bolts And Screws, Titanium Alloy 6al-4v Upset Headed, Heattreated, Roll Threaded (Uns 456400)
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Product Code:SAE AMS7461
Title:Bolts And Screws, Titanium Alloy 6al-4v Upset Headed, Heattreated, Roll Threaded (Uns 456400)
Issuing Committee:Ams G Titanium And Refractory Metals Committee
Scope:APPLICATION: Premium quality bolts and screws for use up to 600 F (315 C) where a high strength lightweight fastener is required.
Product Code:SAE AS1503
Title:Hose, Air Duct, Flexible, Helical Metallic Wire, Supported (Covered), Self Extinguishing
Issuing Committee:G-3, Aerospace Couplings, Fittings, Hose, Tubing Assemblies
Scope:No scope available.【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Goodclinicalpractice
【原文标准名称】:人体医疗器械的临床调查.药品优良临床试验规范
【标准号】:ANSI/AAMI/ISO14155-2010
【标准状态】:现行
【国别】:美国
【发布日期】:2010-01-01
【实施或试行日期】:
【发布单位】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:临床调查;临床试验;控制图;定义(术语);牙科设备;牙科器械;文献;效率;企业;伦理学;评定;人体;植入物(外科);信息;检验师;法律;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;人;性能测试;报告;结果;安全性;规范(验收);外科植入物;外科器械;监督(认可);系统论;试验人员;测试;试验;利用
【英文主题词】:Clinicalinvestigations;Clinicaltesting;Controlcharts;Definitions;Dentalequipment;Dentalinstruments;Documentations;Efficiency;Enterprises;Ethics;Evaluations;Humanbody;Implants(surgical);Information;Inspectors;Law;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;People;Performancetesting;Reports;Results;Safety;Specification(approval);Surgicalimplants;Surgicalinstruments;Surveillance(approval);Systemology;Testpersons;Testing;Trials;Utilization
【摘要】:Addressesgoodclinicalpracticesforthedesign,conduct,recordingandreportingofclinicalinvestigationscarriedoutinhumansubjectstoassessthesafetyandperformanceofmedicaldevicesforregulatorypurposes.Itspecifiesgeneralrequirementsintendedtoprotecttherights,safetyandwell-beingofhumansubjects;ensurethescientificconductoftheclinicalinvestigationandthecredibilityoftheclinicalinvestigationresults;andassistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandotherbodiesinvolvedintheconformityassessmentofmedicaldevices.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:
【正文语种】:英语
