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
时间:2024-05-18 13:13:39 来源: 标准资料网 作者：标准资料网 阅读：8289
【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
【英文标准名称】:StandardTestMethodfordcMagneticPropertiesofMaterialsUsingRingandPermeameterProcedureswithdcElectronicHysteresigraphs
【原文标准名称】:使用DC电磁滞曲线记录仪的参数处理和环形材料的DC磁性能的标准测试方法
【标准号】:ASTMA773/A773M-2001(2009)
【标准状态】:现行
【国别】:
【发布日期】:2001
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:A06.01
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:
【英文主题词】:dchysteresigraph;dchysteresis;Epsteintest;Hallprobe;hysteresisloop;permeameter;ring-typespecimen;Currentmeasurement--direct-current;D-cmagneticproperties;Direct-currentpermeability;Hysteresiseffects;Permeameters(direct-current)
【摘要】:Hysteresigraphtestingpermitsmorerapidandefficientcollectionofdchysteresis(B-Hloop)dataascomparedtothepointbypointballisticTestMethodsA341/A341MandA596/A596M.Theaccuracyandprecisionoftestingiscomparabletotheballisticmethods.Hysteresigraphsareparticularlydesirablefortestingofsemihardandhardmagneticmaterialswhereeithertheentiresecondquadrant(demagnetizationcurve)orentirehysteresisloopisofprimaryconcern.Providedthetestspecimenisrepresentativeofthebulksampleorlot,thistestmethodiswellsuitedfordesign,specificationacceptance,serviceevaluationandresearchanddevelopment.1.1Thistestmethodprovidesdchysteresigraphprocedures(B-Hloopmethods)forthedeterminationofbasicmagneticpropertiesofmaterialsintheformofring,toroidal,link,double-lappedEpsteincores,orotherstandardshapesthatmaybecut,stamped,machined,orgroundfromcast,compacted,sintered,forged,orrolledmaterials.Itincludestestsfornormalinductionandhysteresistakenunderconditionsofcontinuoussweepmagnetization.Rateofsweepmaybevaried,eithermanuallyorautomaticallyatdifferentportionsofthecurvesduringtracing.Totalelapsedtimefortracingahysteresisloopiscommonly10to120sperloop.1.2ThevaluesstatedineitherSIunitsorinch-poundunitsaretoberegardedseparatelyasstandard.Thevaluesstatedineachsystemmaynotbeexactequivalents;therefore,eachsystemshallbeusedindependentlyoftheother.Combiningvaluesfromthetwosystemsmayresultinnon-conformancewiththestandard.1.3Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:N24
【国际标准分类号】:
【页数】:10P.;A4
【正文语种】:
【英文标准名称】:StandardSpecificationforCommonRequirementsforSteelFastenersorFastenerMaterials,orBoth,IntendedforUseatAnyTemperaturefromCryogenictotheCreepRange
【原文标准名称】:在低温至蠕变范围内任何温度下用的钢紧固件或紧固件材料或两者同时使用时通用要求的标准规范
【标准号】:ASTMA962/A962M-2004
【标准状态】:作废
【国别】:美国
【发布日期】:2004
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:温度变化;机械工程;棒钢;螺母;钢;作标记;紧固件;螺栓;低;高;碳;不锈的;元部件
【英文主题词】:high;marking;mechanicalengineering;steelbars;steels;changesoftemperature;fasteners;stainless;bolts;low;components;nuts;carbon
【摘要】:
【中国标准分类号】:J13
【国际标准分类号】:21_060_01
【页数】:8P;A4
【正文语种】:英语