ISO/TS 11135-2-2008 卫生保健品的消毒.环氧乙烷.第2部分:ISO11135-1应用指南
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【英文标准名称】:Sterilizationofhealthcareproducts-Ethyleneoxide-Part2:GuidanceontheapplicationofISO11135-1
【原文标准名称】:卫生保健品的消毒.环氧乙烷.第2部分:ISO11135-1应用指南
【标准号】:ISO/TS11135-2-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-08
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:验收(鉴定);验收规范;检验;交付使用;环氧乙烷;评定;检验(质量保证);杀菌剂;卫生学;检查;说明书;维修;医疗设备;医疗产品;医学科学;医疗技术学;操作;操作者;人员;公共卫生;公共卫生防护;安全;安全工程;安全要求;绝育;灭菌;灭菌器;储存;监督(认可);测试
【英文主题词】:Acceptance(approval);Acceptancespecification;Checks;Commissioning;Definitions;Ethyleneoxide;Evaluations;Examination(qualityassurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Operation;Operators(personnel);Personnel;Publichealth;Publichealthprotection;Safety;Safetyengineering;Safetyrequirements;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Storage;Surveillance(approval);Testing
【摘要】:ThisTechnicalSpecificationprovidesguidancefortherequirementsinISO11135-1:2007.Itdoesnotrepeattherequirementsandisnotintendedtobeusedinisolation.TheexclusionsinISO11135-1applyalsotothisTechnicalSpecification.Foreaseofreference,theclausenumberinginthisTechnicalSpecificationcorrespondstothatinISO11135-1:2007.FurtherguidancefortherequirementsgiveninISO11135-1isalsoincludedinAnnexCofISO11135-1:2007andshouldbeusedinconjunctionwiththisTechnicalSpecification.ThisguidancedocumentisintendedforpeoplewhohaveabasicknowledgeoftheprinciplesofEOsterilizationbutmayneedhelpindetermininghowtobestmeettherequirementscontainedinISO11135-1.ThisdocumentisnotintendedforpeoplelackingabasicknowledgeoftheprinciplesofEOsterilization.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:46P.;A4
【正文语种】:英语
【原文标准名称】:卫生保健品的消毒.环氧乙烷.第2部分:ISO11135-1应用指南
【标准号】:ISO/TS11135-2-2008
【标准状态】:现行
【国别】:国际
【发布日期】:2008-08
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:验收(鉴定);验收规范;检验;交付使用;环氧乙烷;评定;检验(质量保证);杀菌剂;卫生学;检查;说明书;维修;医疗设备;医疗产品;医学科学;医疗技术学;操作;操作者;人员;公共卫生;公共卫生防护;安全;安全工程;安全要求;绝育;灭菌;灭菌器;储存;监督(认可);测试
【英文主题词】:Acceptance(approval);Acceptancespecification;Checks;Commissioning;Definitions;Ethyleneoxide;Evaluations;Examination(qualityassurance);Germicides;Hygiene;Inspection;Instructions;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Operation;Operators(personnel);Personnel;Publichealth;Publichealthprotection;Safety;Safetyengineering;Safetyrequirements;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Storage;Surveillance(approval);Testing
【摘要】:ThisTechnicalSpecificationprovidesguidancefortherequirementsinISO11135-1:2007.Itdoesnotrepeattherequirementsandisnotintendedtobeusedinisolation.TheexclusionsinISO11135-1applyalsotothisTechnicalSpecification.Foreaseofreference,theclausenumberinginthisTechnicalSpecificationcorrespondstothatinISO11135-1:2007.FurtherguidancefortherequirementsgiveninISO11135-1isalsoincludedinAnnexCofISO11135-1:2007andshouldbeusedinconjunctionwiththisTechnicalSpecification.ThisguidancedocumentisintendedforpeoplewhohaveabasicknowledgeoftheprinciplesofEOsterilizationbutmayneedhelpindetermininghowtobestmeettherequirementscontainedinISO11135-1.ThisdocumentisnotintendedforpeoplelackingabasicknowledgeoftheprinciplesofEOsterilization.
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:46P.;A4
【正文语种】:英语
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