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【英文标准名称】:Packagingforterminallysterilizedmedicaldevices-Part5:Sealablepouchesandreelsofporousmaterialsandplasticfilmconstruction-Requirementsandtestmethods;EnglishversionofDINEN868-5:2009-09
【原文标准名称】:最终灭菌医疗器械的包装.第5部分:多孔材料和塑料薄膜结构的可密封袋和卷轴.试验方法和要求.英文版本DINEN868-5-2009-09
【标准号】:DINEN868-5-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:
【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;袋;定义(术语);尺寸规格;柔性管;可弯曲塑料管包装;货物;热封;热密封材料;卫生学;检验;叠层箔;作标记;医疗器械;医疗器材;医疗产品;医学科学;医疗技术学;包装件;包装材料;包装试验;纸;纸袋;塑料;产品;安全性;安全性要求;操作程序;规范(验收);绝育;灭菌;消毒纸;消毒物品;灭菌器;储存;试验;公差(测量);透明包装;透明灭菌包装;运输包装;使用;证实
【英文主题词】:Applications;Bags;Definitions;Dimensions;Flexiblepipes;Flexibleplasticstubepackaging;Goods;Heat-sealing;Heat-sealingmaterials;Hygiene;Inspection;Laminatedfoils;Marking;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Packages;Packagingmaterial;Packagingtests;Paper;Paperbags;Plastics;Products;Safety;Safetyrequirements;Sequenceofoperations;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizationpapers;Sterilizedgoods;Sterilizers;Storage;Testing;Tolerances(measurement);Transparentpackages;Transparentsterilizingpacking;Transportpacking;Use;Validation
【摘要】:ThispartofEN868providestestmethodsandvaluesforsealablepouchesandreelsmanufacturedfromporousmaterialscomplyingwitheitherEN868part2,3,6,7,9or10andplasticfilmcomplyingwithClause4usedassterilebarriersystemsand/orpackagingsystemsthatareintendedtomaintainsterilityofterminallysterilizedmedicaldevicestothepointofuse.NOTE1Theneedforaprotectivepackagingmaybedeterminedbythemanufacturerandtheuser.ThispartofEN868onlyintroducesperformancerequirementsandtestmethodsthatarespecifictotheproductscoveredbythispartofEN868butdoesnotaddormodifythegeneralrequirementsspecifiedinENISO11607-1.Assuch,theparticularrequirementsin4.2to4.5canbeusedtodemonstratecompliancewithoneormorebutnotalloftherequirementsofENISO11607-1.ThematerialsspecifiedinthispartofEN868areintendedforsingleuseonly.NOTE2Whenadditionalmaterialsareusedinsidethesterilebardersysteminordertoeasetheorganization,dryingorasepticpresentation(e.g.innerwrap,containerfilter,indicators,packinglists,mats,instrumentorganizersets,traylinersoranadditionalenvelopearoundthemedicaldevice)thenotherrequirements,includingthedeterminationoftheacceptabilityofthesematerialsduringvalidationactivities,mayapply.
【中国标准分类号】:C08
【国际标准分类号】:11_080_30
【页数】:22P.;A4
【正文语种】:英语


【英文标准名称】:Soilquality-Determinationoftheeffectsofpollutantsonsoilflora-Effectsofchemicalsontheemergenceandgrowthofhigherplants
【原文标准名称】:土壤质量.污染物对土壤植物群影响的测定.化学品对高等植物的发芽和生长的影响
【标准号】:BSISO11269-2-2005
【标准状态】:作废
【国别】:英国
【发布日期】:2006-01-18
【实施或试行日期】:2006-01-18
【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】:农业;生物测定;生物分析和试验;生物试验;化合物;比较分析法;土壤组分;污染;定义;测定;效率;植物群;生长;损害;杂质;数学计算;测量;植物;污染物;质量;播种;土壤污染;土壤普查;土壤试验;土壤;试验报告;试验;毒物;毒性;型式
【英文主题词】:Agriculture;Bioassay;Biologicalanalysisandtesting;Biologicaltests;Bottom;Bushings;Chemicals;Climate;Comparisonanalysis;Compositionoftheground;Contamination;Definitions;Determination;Efficiency;Flora;Growth;Impairmentdamage;Impurities;Mathematicalcalculations;Measurement;Plants;Pollutants;Pollution;Quality;Seedings;Soilpollution;Soilsurveys;Soiltesting;Soils;Testreports;Testresults;Testing;Toxic;Toxicity;Types
【摘要】:ThispartofISO11269describesamethodthatisapplicabletothedeterminationofpossibletoxiceffectsofsolidorliquidchemicalsincorporatedinsoilontheemergenceandearlystagesofgrowthanddevelopmentofavarietyofterrestrialplants.Itdoesnotgiveanindicationofdamageresultingfromdirectcontactofseedlingswiththechemicalinthevapourorliquidphaseoutsidethesoilenvironment.Themethodisalsoapplicabletothecomparisonofsoilsofknownandunknownquality.InformationonhowtoadaptthemethodforthispurposeisgiveninAnnexB.
【中国标准分类号】:B11
【国际标准分类号】:13_080_30
【页数】:20P;A4
【正文语种】:英语