DIN EN ISO 11607-1-2009 最终无菌医疗器械的包装.第1部分:原材料,无菌阻隔系统和包装系统的要求(ISO11607-1-2006).英文版本DINENISO11607-1-2009-09
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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part1:Requirementsformaterials,sterilebarriersystemsandpackagingsystems(ISO11607-1:2006);EnglishversionofDINENISO11607-1:2009-09
【原文标准名称】:最终无菌医疗器械的包装.第1部分:原材料,无菌阻隔系统和包装系统的要求(ISO11607-1-2006).英文版本DINENISO11607-1-2009-09
【标准号】:DINENISO11607-1-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用;生物适应性;生物危害;闭塞物;兼容性;状态调节;封盖物;定义(术语);密度;一次性用品;英语;一般条件;微生物;卫生学;信息;检验;作标记;材料规范;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;方法;包装件;包装材料;包装试验;渗透;物理试验;产品;公共卫生;质量;质量保证;质量管理;规格试验;试剂;重新使用;安全性;安全要求;抽样方法;操作程序;规范;规范(验收);稳定性;无菌阻隔系统;无菌;绝育;灭菌;消毒物品;灭菌器;储存;系统;测试;毒性;运输;使用;证实;外观检查(测试)
【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】:ThispartofISO11607specifiestherequirementsandtestmethodsformaterials,preformedsterilebarriersystems,sterilebarriersystemsandpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicesuntilthepointofuse.ThispartofISO11607isapplicabletoindustry,tohealthcarefacilities,andwherevermedicaldevicesareplacedinsterilebarriersystemsandsterilized.ThispartofISO11607doesnotcoverallrequirementsforsterilebarriersystemsandpackagingsystemsformedicaldevicesthataremanufacturedaseptically.Additionalrequirementsmightalsobenecessaryfordrug/devicecombinations.ThispartofISO11607doesnetdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:33P.;A4
【正文语种】:英语
【原文标准名称】:最终无菌医疗器械的包装.第1部分:原材料,无菌阻隔系统和包装系统的要求(ISO11607-1-2006).英文版本DINENISO11607-1-2009-09
【标准号】:DINENISO11607-1-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:应用;生物适应性;生物危害;闭塞物;兼容性;状态调节;封盖物;定义(术语);密度;一次性用品;英语;一般条件;微生物;卫生学;信息;检验;作标记;材料规范;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;方法;包装件;包装材料;包装试验;渗透;物理试验;产品;公共卫生;质量;质量保证;质量管理;规格试验;试剂;重新使用;安全性;安全要求;抽样方法;操作程序;规范;规范(验收);稳定性;无菌阻隔系统;无菌;绝育;灭菌;消毒物品;灭菌器;储存;系统;测试;毒性;运输;使用;证实;外观检查(测试)
【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】:ThispartofISO11607specifiestherequirementsandtestmethodsformaterials,preformedsterilebarriersystems,sterilebarriersystemsandpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicesuntilthepointofuse.ThispartofISO11607isapplicabletoindustry,tohealthcarefacilities,andwherevermedicaldevicesareplacedinsterilebarriersystemsandsterilized.ThispartofISO11607doesnotcoverallrequirementsforsterilebarriersystemsandpackagingsystemsformedicaldevicesthataremanufacturedaseptically.Additionalrequirementsmightalsobenecessaryfordrug/devicecombinations.ThispartofISO11607doesnetdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:33P.;A4
【正文语种】:英语
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