【英文标准名称】:Clinicalinvestigationofmedicaldevicesforhumansubjects-Generalrequirements
【原文标准名称】:人用医疗设备的临床调查.一般要求
【标准号】:BSENISO14155-1-2003
【标准状态】:作废
【国别】:英国
【发布日期】:2003-03-12
【实施或试行日期】:2003-03-12
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:规范(验收);医疗技术学;外科植入物;外科植入物;安全;文献工作;手术器械;试验;检验师;利用;医疗产品;牙科设备;企业;人;人体;报告;结果;牙科器械;定义;评定;监督(认可);临床试验;医学科学;医疗设备;性能试验;临床调查;效率
【英文主题词】:Clinicalinvestigations;Clinicaltesting;Controlcharts;Definitions;Dentalequipment;Dentalinstruments;Documentations;Efficiency;Enterprises;Evaluations;Humanbody;Implants(surgical);Information;Inspectors;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;People;Performancetesting;Reports;Results;Safety;Specification(approval);Surgicalimplants;Surgicalinstruments;Surveillance(approval);Systemology;Testing;Trials;Utilization
【摘要】:ISO14155-1:2002definesproceduresfortheconductandperformanceofclinicalinvestigationsofmedicaldevices.Itspecifiesgeneralrequirementsintendedto:protecthumansubjects;ensurethescientificconductoftheclinicalinvestigation;assistsponsors,monitors,investigators,ethicscommittees,regulatoryauthoritiesandbodiesinvolvedintheconformityassessmentofmedicaldevices.ISO14155-1:2002specifiesrequirementsfortheconductofaclinicalinvestigationsuchthatitestablishestheperformanceofthemedicaldeviceduringtheclinicalinvestigationintendedtomimicnormalclinicaluse,revealsadverseeventsundernormalconditionsofuse,andpermitsassessmentoftheacceptableriskshavingregardtotheintendedperformanceofthemedicaldevice,specifiesrequirementsfortheorganization,conduct,monitoring,datacollectionanddocumentationoftheclinicalinvestigationofamedicaldevice,isapplicabletoallclinicalinvestigation(s)ofmedicaldeviceswhoseclinicalperformanceandsafetyisbeingassessedinhumansubjects.ISO14155-1:2002isnotapplicabletoinvitrodiagnosticmedicaldevices.
【中国标准分类号】:C05
【国际标准分类号】:11_100_20
【页数】:34P.;A4
【正文语种】:英语


Product Code:SAE J1502
Title:Connections for Fluid Power and General Use-Hydraulic Couplings-Diagnostic
Issuing Committee:Hydraulic Tube Fittings Committee
Scope: SAE J1052 specifies dimensions, performance requirements, and test procedures for the male half of a diagnostic coupler with either a metric M14x1.5 or an inch 9/16-18 straight thread stud end. The coupler is designed for use with a mineral based hydraulid fluid. It is used on machines specified in SAE J1116. It does not apply to the mating hydraulic quick action couplings not on the machine.Diagnostic couplings in accordance with this part of ISO may be used at a working pressure of 41.4 MPa (414 bar). The permissible working pressure depends upon the materials, design, working conditions, application, etc.Conformance to the dimensional information in this part of SAE J1502 does not guarantee rated performance. Each manufacturer should perform testing according to the specification contained in this document to ensure that components comply with the performance rating.
Rationale: SAE J1052 specifies dimensions, performance requirements, and test procedures for the male half of a diagnostic coupler with either a metric M14x1.5 or an inch 9/16-18 straight thread stud end. The coupler is designed for use with a mineral based hydraulid fluid. It is used on machines specified in SAE J1116. It does not apply to the mating hydraulic quick action couplings not on the machine.Diagnostic couplings in accordance with this part of ISO may be used at a working pressure of 41.4 MPa (414 bar). The permissible working pressure depends upon the materials, design, working conditions, application, etc.Conformance to the dimensional information in this part of SAE J1502 does not guarantee rated performance. Each manufacturer should perform testing according to the specification contained in this document to ensure that components comply with the performance rating.