DIN EN ISO 10993-3-2009 医疗器械的生物学评价.第3部分:遗传毒性、致癌性和生殖毒性的试验(ISO10993-3-2003);德文版本ENISO10993-3-2009

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part3:Testsforgenotoxicity,carcinogenicityandreproductivetoxicity(ISO10993-3:2003);EnglishversionofDINENISO10993-3:2009-08
【原文标准名称】:医疗器械的生物学评价.第3部分:遗传毒性、致癌性和生殖毒性的试验(ISO10993-3-2003);德文版本ENISO10993-3-2009
【标准号】:DINENISO10993-3-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【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】:生物测定;生物的;生物危害;生物试验;致癌物材料;致癌物;定义;牙科设备;牙科器械;牙科材料;评定;精密机械;基因;遗传学;遗传毒性;植入物(外科);材料;医疗器械;医疗设备;医疗产品;医学科学;方法;准备;复制;生殖系统;试样;试样制备;外科设备;外科植入物;试验;毒性
【英文主题词】:Bioassay;Biological;Biologicalhazards;Biologicaltests;Carcinogenicmaterials;Carcinogens;Definitions;Dentalequipment;Dentalinstruments;Dentalmaterials;Evaluations;Finemechanics;Genes;Genetics;Genotoxicity;Implants(surgical);Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Methods;Preparation;Reproductions;Reproductivesystem;Samples;Specimenpreparation;Surgicalequipment;Surgicalimplants;Testing;Toxicity
【摘要】:ThispartofISO10993specifiesstrategiesforhazardidentificationandtestsonmedicaldevicesforthefollowingbiologicalaspects:--genotoxicity,--carcinogenicity,and--reproductiveanddevelopmentaltoxicity.ThispartofISO10993isapplicableforevaluationofamedicaldevicewhosepotentialforgenotoxicity,carcinogenicityorreproductivetoxicityhasbeenidentified.NOTEGuidanceonselectionoftestsisprovidedinISO10993-1.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:26P.;A4
【正文语种】:英语

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上一篇: DIN EN ISO 8836-2009 呼吸道用吸气导管(ISO8836-2007,修正版本2008-03-15);德文版本ENISO8836-2009
下一篇: DIN EN ISO 21536-2009 非活性外科植入物.关节替代植入物.膝关节替代用植入物特殊要求(ISO21536-2007);德文版本ENISO21536-2009

Product Code:SAE J1752/3
Title:Measurement of Radiated Emissions From Integrated Circuits-Tem/Wideband Tem (Gtem) Cell Method; Tem Cell (150 Khz to 1 Ghz), Wideband Tem Cell (150 Khz to 8 Ghz)
Issuing Committee:Electromagnetic Radiation (Emr) Task Force
Scope:This measurement procedure defines a method for measuring the electromagnetic radiation from an integrated circuit (IC). The IC being evaluated is mounted on an IC test printed circuit board (PCB) that is clamped to a mating port (referred to as a wall port) cut in the top or bottom of a TEM or wideband TEM (GTEM) cell. The test board is not in the cell as in the conventional usage but becomes a part of the cell wall. This method is applicable to any TEM or GTEM cell modified to incorporate the wall port; however, the measured RF voltage is affected by the septum to test board (wall) spacing. This procedure was developed using a 1 GHz TEM cell with a septum to wall spacing of 45 mm and a GTEM cell with average septum to wall spacing of 45 mm over the port area. Other cells may not produce identical spectral output but may be used for comparative measurements, subject to their frequency and sensitivity limitations. A conversion factor may allow comparisons between data measured on TEM or GTEM cells with different septum to wall spacing. The IC test board controls the geometry and orientation of the operating IC relative to the cell and eliminates any connecting leads within the cell (these are on the backside of the board, which is outside the cell). For the TEM cell, one of the 50 gV?ports is terminated with a 50 gV?load. The other 50 gV?port for a TEM cell, or the single 50 gV?port for a GTEM cell, is connected to the input of a spectrum analyzer or receiver that measures the RF emissions emanating from the IC and coupled onto the septum of the TEM cell.【英文标准名称】:Safetyofmachinery-Hygienerequirementsforthedesignofmachinery
【原文标准名称】:机械安全.机械设计的卫生要求
【标准号】:BSENISO14159-2004
【标准状态】:作废
【国别】:英国
【发布日期】:2004-02-25
【实施或试行日期】:2004-02-25
【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】:维修;安全要求;清洁处理;定义;设计;消费者保护;危险;操作手册;机器;消费者;安全;安全措施;保健;规范(验收);企业;卫生学;危害
【英文主题词】:Cleaning;Cleaningmaterials;Consumerprotection;Consumers;Definitions;Design;Disinfectants;Disinfections;Elastomers;Enterprises;Hazards;Healthprotection;Hygiene;Machines;Maintenance;Metals;Micro-organisms;Microorganisms;Microsolderingequipment;Operatinginstructions;Operationmanuals;Pathogens;Polymers;Risk;Riskanalysis;Safety;Safetymeasures;Safetyofmachinery;Safetyrequirements;Selection;Specification(approval);Sterilization(birthcontrol);Testing;Verification;Vulcanizedrubber
【摘要】:ThisInternationalStandardspecifieshygienerequirementsofmachinesandprovidesinformationfortheintendedusetobeprovidedbythemanufacturer.Itappliestoalltypesofmachinesandassociatedequipmentusedinapplicationswherehygieneriskstotheconsumeroftheproductcanoccur.ThisInternationalStandarddoesnotcoverrequirementsrelativetotheuncontrolledegressofmicrobiologicalagentsfromthemachine.
【中国标准分类号】:J04
【国际标准分类号】:13_110
【页数】:44P;A4
【正文语种】:英语