【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


【英文标准名称】:Cranes-Conditionmonitoring-Part1:General
【原文标准名称】:起重机状态监控第1部分:总则
【标准号】:ISO12482-1-1995
【标准状态】:现行
【国别】:国际
【发布日期】:1995-11
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC96
【标准类型】:()
【标准水平】:()
【中文主题词】:条件控制;定义;提升装置;事故预防;提升设备;监督(认可);一般条件;装卸设备;起重机
【英文主题词】:Accidentprevention;Conditionmonitoring;Cranes;Definitions;Generalconditions;Handlingequipment;Liftingdevices;Liftingequipment;Surveillance(approval)
【摘要】:Purposeofthispartistoensurethatthedesignconstraintsoftheintendeduseofacraneareclearlyidentifiedandtodefineactionstobetakenwhenthecranehasbeenusedoveraperiodoftimeandhasapproachedtheseconstraints,toensureanewsafeworkingperiod.Adescriptionisgivenofthespecialassessmentrequiredtomonitortheconditionofacrane.
【中国标准分类号】:J80
【国际标准分类号】:53_020_20
【页数】:12P.;A4
【正文语种】:英语