ISO/IEC Guide 63-1999 医疗器械安全方面的开发并纳入国际标准指南
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【英文标准名称】:GuidetothedevelopmentandinclusionofsafetyaspectsinInternationalStandardsformedicaldevices
【原文标准名称】:医疗器械安全方面的开发并纳入国际标准指南
【标准号】:ISO/IECGuide63-1999
【标准状态】:现行
【国别】:国际
【发布日期】:1999
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Definition;Definitions;Guidebooks;Internationalstandards;Medicalequipment;Medicalproducts;Safety;Safetyrequirements;Standardization;Standards;Terminology
【摘要】:ThisGuideprovidesanapproachtowritinginternationalstandardsformedicaldevicesthattakesintoaccountthehazardsofmedicaluse,theroleofstandardsinmanagingriskinrelationtothemedicalneedforthedeviceandtheuseofstandardsinmedicaldevicedesign,manufactureandregulation.ThisGuidewillalsohelpthosewhousemedicaldevicestandardstounderstandwhatsuchstandardsareintendedtoaccomplish.Amongsuchusersare:—usersofmedicaldevices;—hospitaladministrators;—personnelinvolvedintheprocurementofmedicaldevices;—regulatoryauthorities;—personsresponsibleforthedesignandconstructionofpatientcarefacilities;—personsresponsiblefortheinstallationandmaintenanceofmedicaldevices;—manufacturersofmedicaldevices;—personswhoassemblesystemsofmedicaldevicesfrommorethanonemanufacturer.ThissectoralGuideisintendedtobereadinconjunctionwithISO/IECGuide51.
【中国标准分类号】:C30
【国际标准分类号】:01_120;11_020;11_040_01
【页数】:8P.;A4
【正文语种】:英语
【原文标准名称】:医疗器械安全方面的开发并纳入国际标准指南
【标准号】:ISO/IECGuide63-1999
【标准状态】:现行
【国别】:国际
【发布日期】:1999
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Definition;Definitions;Guidebooks;Internationalstandards;Medicalequipment;Medicalproducts;Safety;Safetyrequirements;Standardization;Standards;Terminology
【摘要】:ThisGuideprovidesanapproachtowritinginternationalstandardsformedicaldevicesthattakesintoaccountthehazardsofmedicaluse,theroleofstandardsinmanagingriskinrelationtothemedicalneedforthedeviceandtheuseofstandardsinmedicaldevicedesign,manufactureandregulation.ThisGuidewillalsohelpthosewhousemedicaldevicestandardstounderstandwhatsuchstandardsareintendedtoaccomplish.Amongsuchusersare:—usersofmedicaldevices;—hospitaladministrators;—personnelinvolvedintheprocurementofmedicaldevices;—regulatoryauthorities;—personsresponsibleforthedesignandconstructionofpatientcarefacilities;—personsresponsiblefortheinstallationandmaintenanceofmedicaldevices;—manufacturersofmedicaldevices;—personswhoassemblesystemsofmedicaldevicesfrommorethanonemanufacturer.ThissectoralGuideisintendedtobereadinconjunctionwithISO/IECGuide51.
【中国标准分类号】:C30
【国际标准分类号】:01_120;11_020;11_040_01
【页数】:8P.;A4
【正文语种】:英语
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