BS EN ISO 11607-1-2006 终端无菌医学设备的包装.原材料、消毒阻挡系统和包装的要求
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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Requirementsformaterials,sterilebarriersystemsandpackagingsystems
【原文标准名称】:终端无菌医学设备的包装.原材料、消毒阻挡系统和包装的要求
【标准号】:BSENISO11607-1-2006
【标准状态】:作废
【国别】:英国
【发布日期】:2006-05-31
【实施或试行日期】:2006-05-31
【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】:闭塞物;定义;可处置的;一般条件;卫生学;检验;材料规范;医疗设备;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;物理试验;产品;公共卫生;质量;质量保证;质量管理;规格试验;重新使用;安全;安全要求;抽样方法;规范;规范(验收);稳定性;消毒阻挡系统;无菌;灭菌;消毒物品;灭菌器;储存;试验;应用;证实;外观检查(试验)
【英文主题词】:Applications;Biocompatibility;Biologicalhazards;Closures;Compatibility;Conditioning;Covers;Definitions;Density;Disposables;Englishlanguage;Generalconditions;Germs;Hygiene;Information;Inspection;Marking;Materialsspecification;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Packages;Packagingmaterial;Packagingtests;Permability;Physicaltesting;Products;Publichealth;Quality;Qualityassurance;Qualitymanagement;Ratingtests;Reagents;Reuse;Safety;Safetyrequirements;Samplingmethods;Sequenceofoperations;Specification;Specification(approval);Stability;Sterilebarriersystems;Sterility;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Systems;Testing;Toxicity;Transport;Use;Validation;Visualinspection(testing)
【摘要】:ISO11607-1:2006specifiestherequirementsandtestmethodsformaterials,preformedsterilebarriersystems,sterilebarriersystemsandpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicesuntilthepointofuse.ISO11607-1:2006isapplicabletoindustry,tohealthcarefacilities,andwherevermedicaldevicesareplacedinsterilebarriersystemsandsterilized.ISO11607-1:2006doesnotcoverallrequirementsforsterilebarriersystemsandpackagingsystemsformedicaldevicesthataremanufacturedaseptically.Additionalrequirementsmightalsobenecessaryfordrug/devicecombinations.ISO11607-1:2006doesnotdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:36P.;A4
【正文语种】:英语
【原文标准名称】:终端无菌医学设备的包装.原材料、消毒阻挡系统和包装的要求
【标准号】:BSENISO11607-1-2006
【标准状态】:作废
【国别】:英国
【发布日期】:2006-05-31
【实施或试行日期】:2006-05-31
【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】:闭塞物;定义;可处置的;一般条件;卫生学;检验;材料规范;医疗设备;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;物理试验;产品;公共卫生;质量;质量保证;质量管理;规格试验;重新使用;安全;安全要求;抽样方法;规范;规范(验收);稳定性;消毒阻挡系统;无菌;灭菌;消毒物品;灭菌器;储存;试验;应用;证实;外观检查(试验)
【英文主题词】:Applications;Biocompatibility;Biologicalhazards;Closures;Compatibility;Conditioning;Covers;Definitions;Density;Disposables;Englishlanguage;Generalconditions;Germs;Hygiene;Information;Inspection;Marking;Materialsspecification;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Packages;Packagingmaterial;Packagingtests;Permability;Physicaltesting;Products;Publichealth;Quality;Qualityassurance;Qualitymanagement;Ratingtests;Reagents;Reuse;Safety;Safetyrequirements;Samplingmethods;Sequenceofoperations;Specification;Specification(approval);Stability;Sterilebarriersystems;Sterility;Sterilization(birthcontrol);Sterilization(hygiene);Sterilizedgoods;Sterilizers;Storage;Systems;Testing;Toxicity;Transport;Use;Validation;Visualinspection(testing)
【摘要】:ISO11607-1:2006specifiestherequirementsandtestmethodsformaterials,preformedsterilebarriersystems,sterilebarriersystemsandpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicesuntilthepointofuse.ISO11607-1:2006isapplicabletoindustry,tohealthcarefacilities,andwherevermedicaldevicesareplacedinsterilebarriersystemsandsterilized.ISO11607-1:2006doesnotcoverallrequirementsforsterilebarriersystemsandpackagingsystemsformedicaldevicesthataremanufacturedaseptically.Additionalrequirementsmightalsobenecessaryfordrug/devicecombinations.ISO11607-1:2006doesnotdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:36P.;A4
【正文语种】:英语
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