ISO 17665-1-2006 保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求
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【英文标准名称】:Sterilizationofhealthcareproducts-Moistheat-Part1:Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求
【标准号】:ISO17665-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-08
【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);检验;交付使用;定义;试验(质量保证);杀菌剂;热学;加热消毒;卫生学;监测;说明书;大范围设备;维修;医疗设备;医疗产品;医学科学;医疗技术学;方法;潮气;操作;包装件;性能;人员;公共卫生;公共保健防护;合格;质量管理;检修;常规试验;卫生工程;规范(验收);蒸汽;蒸汽灭菌;蒸汽灭菌器;辐射灭菌;灭菌;消毒物品;灭菌器;监督(认可);试验;证实;验证
【英文主题词】:Acceptance(approval);Bearings;Biologicalhazards;Checks;Clearing;Commissioning;Compatibility;Control;Definitions;Equipment;Evaluations;Examination(qualityassurance);Germicides;Guidebooks;Heat;Heatsterilization;Humid;Hygiene;Information;Inspection;Instructions;Instrumentation;Largescaleequipment;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Moisture;Operation;Packages;Performance;Personnel;Products;Publichealth;Publichealthprotection;Qualifications;Qualitymanagement;Repair;Routinetests;Sanitaryengineering;Specification(approval);Steam;Steamsterilization;Steamsterilizers;Sterilizationbyirradiation;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Surveillance(approval);Testing;Validation;Verification
【摘要】:1.1Inclusions1.1.1ThispartofISO17665specifiesrequirementsforthedevelopment,validationandroutinecontrolofamoistheatsterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthispartofISO17665islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherhealthcareproducts.1.1.2MoistheatsterilizationprocessescoveredbythispartofISO17665includebutarenotlimitedto:a)saturatedsteamventingsystems;b)saturatedsteamactiveairremovalsystems;c)airsteammixtures;d)waterspray;e)waterimmersion.NOTESeealsoAnnexE.1.2Exclusions1.2.1ThispartofISO17665doesnotspecifyrequirementsfordevelopment,validation,androutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldt-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.NOTESeealsoISO22442-1,ISO22442-2andISO22442-3.1.2.2ThispartofISO17665doesnotapplytothosesterilizationprocessesthatarebasedonacombinationofmoistheatwithotherbiocidalagents(e.g.formaldehyde)asthesterilizingagent.1.2.3ThispartofISO17665doesnotdetailaspecifiedrequirementfordesignatingamedicaldeviceas"sterile."NOTEAttentionisdrawntonationalorregionalrequirementsfordesignatingmedicaldevicesas"sterile."See,forexample,EN556-1orANSI/AAMIST67.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:38P;A4
【正文语种】:英语
【原文标准名称】:保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求
【标准号】:ISO17665-1-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-08
【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);检验;交付使用;定义;试验(质量保证);杀菌剂;热学;加热消毒;卫生学;监测;说明书;大范围设备;维修;医疗设备;医疗产品;医学科学;医疗技术学;方法;潮气;操作;包装件;性能;人员;公共卫生;公共保健防护;合格;质量管理;检修;常规试验;卫生工程;规范(验收);蒸汽;蒸汽灭菌;蒸汽灭菌器;辐射灭菌;灭菌;消毒物品;灭菌器;监督(认可);试验;证实;验证
【英文主题词】:Acceptance(approval);Bearings;Biologicalhazards;Checks;Clearing;Commissioning;Compatibility;Control;Definitions;Equipment;Evaluations;Examination(qualityassurance);Germicides;Guidebooks;Heat;Heatsterilization;Humid;Hygiene;Information;Inspection;Instructions;Instrumentation;Largescaleequipment;Maintenance;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Moisture;Operation;Packages;Performance;Personnel;Products;Publichealth;Publichealthprotection;Qualifications;Qualitymanagement;Repair;Routinetests;Sanitaryengineering;Specification(approval);Steam;Steamsterilization;Steamsterilizers;Sterilizationbyirradiation;Sterilization(hygiene);Sterilizedgoods;Sterilizers;Surveillance(approval);Testing;Validation;Verification
【摘要】:1.1Inclusions1.1.1ThispartofISO17665specifiesrequirementsforthedevelopment,validationandroutinecontrolofamoistheatsterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthispartofISO17665islimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherhealthcareproducts.1.1.2MoistheatsterilizationprocessescoveredbythispartofISO17665includebutarenotlimitedto:a)saturatedsteamventingsystems;b)saturatedsteamactiveairremovalsystems;c)airsteammixtures;d)waterspray;e)waterimmersion.NOTESeealsoAnnexE.1.2Exclusions1.2.1ThispartofISO17665doesnotspecifyrequirementsfordevelopment,validation,androutinecontrolofaprocessforinactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeldt-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.NOTESeealsoISO22442-1,ISO22442-2andISO22442-3.1.2.2ThispartofISO17665doesnotapplytothosesterilizationprocessesthatarebasedonacombinationofmoistheatwithotherbiocidalagents(e.g.formaldehyde)asthesterilizingagent.1.2.3ThispartofISO17665doesnotdetailaspecifiedrequirementfordesignatingamedicaldeviceas"sterile."NOTEAttentionisdrawntonationalorregionalrequirementsfordesignatingmedicaldevicesas"sterile."See,forexample,EN556-1orANSI/AAMIST67.
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:38P;A4
【正文语种】:英语
下载地址: 点击此处下载