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ISO 10993-4-2002 医疗器械的生物评定.第4部分:与血液相互作用的试验的选择

作者:标准资料网 时间:2024-05-26 18:27:32  浏览:8941   来源:标准资料网
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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part4:Selectionoftestforinteractionswithblood
【原文标准名称】:医疗器械的生物评定.第4部分:与血液相互作用的试验的选择
【标准号】:ISO10993-4-2002
【标准状态】:现行
【国别】:国际
【发布日期】:2002-10
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC194
【标准类型】:()
【标准水平】:()
【中文主题词】:生物试验;相互作用;外科植入物;外科植入物;血液;医疗设备;导则;生物测定;分类;牙科学;牙科器械;牙科设备;医学科学;外科设备;医疗产品;定义;材料;试验
【英文主题词】:Bioassay;Biologicalhazards;Biologicaltests;Blood;Classification;Definitions;Dentalequipment;Dentalinstruments;Dentistry;Evaluations;Guidelines;Haematology;Implants(surgical);Invitro;Interaction;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Risk;Specification(approval);Surgicalequipment;Surgicalimplants;Testing
【摘要】:ThispartofISO10993providesgeneralrequirementsforevaluatingtheinteractionsofmedicaldeviceswithblood.Itdescribesa)aclassificationofmedicalanddentaldevicesthatareintendedforuseincontactwithblood,basedontheintendeduseanddurationofcontactasdefinedinISO10993-1,b)thefundamentalprinciplesgoverningtheevaluationoftheinteractionofdeviceswithblood,c)therationaleforstructuredselectionoftestsaccordingtospecificcategories,togetherwiththeprinciplesandscientificbasisofthesetests.Detailedrequirementsfortestingcannotbespecifiedbecauseoflimitationsintheknowledgeandprecisionoftestsforinteractionsofdeviceswithblood.ThispartofISO10993describesbiologicalevaluationingeneraltermsandmaynotnecessarilyprovidesufficientguidancefortestmethodsforaspecificdevice.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:34P;A4
【正文语种】:英语


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【英文标准名称】:Aerospaceseries-Electricalcontactsusedinelementsofconnection-Part056:contacts,electrical,male,thermocoupleNiCr,typeC,crimp,classT-Productstandard.
【原文标准名称】:航空航天系列.用于连接部件的电接触器.第056部分:T级、卷边、C型、镍铬热电偶凸形电接触器.产品标准
【标准号】:NFL53-201-056-2006
【标准状态】:现行
【国别】:法国
【发布日期】:2006-12-01
【实施或试行日期】:2006-12-05
【发布单位】:法国标准化协会(FR-AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:航空航天运输;航空运输;插接件连接;触点;触点连接;触点插入;名称与符号;尺寸;电缆;电触点;电力设备;紧固件;材料;镍铬热电偶;针触点;产品标准;航天运输;规范(验收);表面防护;试验;热电偶;类型
【英文主题词】:Aerospacetransport;Airtransport;Connectoredjoints;Contact;Contactconnection;Contactinserts;Designations;Dimensions;Electriccables;Electriccontacts;Electricalinstallations;Fasteners;Materials;Multilingual;Nickelcompounds;Pincontacts;Productstandards;Spacetransport;Specification(approval);Surfaceprotection;Testing;Thermocouples;Types
【摘要】:
【中国标准分类号】:V25
【国际标准分类号】:49_060
【页数】:23P;A4
【正文语种】:其他


MIL-HDBK-59B, MILITARY HANDBOOK: CONTINUOUS ACQUISITION and LIFE-CYCLE SUPPORT (CALS) IMPLEMENTATION GUIDE (11 JUN 1994) [NO S/S DOCUMENT]., Continuous Acquisition and Life-Cycle Support (CALS) is a Department of Defense (DoD) and industry strategy to enable more effective generation, exchange, management, and use of digital data supporting defense systems. The primary goal of the CALS strategy is to migrate from manual, paper-intensive defense system operations to integrated, highly automated acquisition and support processes. This handbook provides information and guidance for applying the CALS strategy to the acquisition, management, and use of digital data in accordance with (IAW) DoD Instruction (DoDI) 5000.2. The primary focus of this handbook is the acquisition of digital data products and information services in support of defense systems. It addresses: a. CALS strategy; b. CALS policy; c. Acquisition process guidance; d. Special considerations for existing defense systems; and e. DoD infrastructure modernization-Joint CALS (JCALS).

 

MIL-HDBK-59B (NOTICE 1), MILITARY HANDBOOK: CONTINUOUS ACQUISITION AND LIFE-CYCLE (CALS) SUPPORT IMPLEMENTATION GUIDE (10 SEP 1997) [NO SUPERSEDING DOCUMENT]., MIL-HDBK-59B, dated 10 June 1994, is hereby canceled. Information and guidance for applying the CALS strategy to the acquisition, management, and use of digital data is contained in the Defense Acquisition Deskbook, Section 3.7, ?Continuous Acquisition and Life-cycle Support (CALS)?. (The Defense Acquisition Deskbook may be downloaded from the Defense Acquisition Deskbook website at http://www.deskbook.osd.mil; Government personnel can obtain a copy on CD-ROM through the Defense Acquisition Deskbook Joint Program Office, 2275 D Street, Bldg. 16, Wright-Patterson AFB, OH 45433-7233, and contractor subscriptions for the CD-ROM are available through the Government Printing Office at (202) 512-1800)).


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