EMC Standards and Their Application

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emc辐射值标准

emc辐射值标准

emc辐射值标准EMC辐射值标准是衡量电磁辐射水平的一种指标,用于评估电子设备对人体健康的潜在影响。

本文将介绍EMC辐射值标准的背景、应用范围、测量方法以及相关的安全性评估。

一、背景电子设备的广泛应用给人们的生活带来了很大的便利,但同时也引发了对电磁辐射对人体健康的担忧。

为了保护公众的健康,各国纷纷制定了相关的电磁辐射标准,其中EMC辐射值标准是最常用的一种。

二、应用范围EMC辐射值标准适用于各种电子设备,包括通信设备、无线电设备、电视机、计算机等。

这些设备在正常工作时会产生电磁辐射,因此需要通过测量其辐射值来评估其对人体健康的潜在影响。

三、测量方法测量EMC辐射值需要使用专业的测试仪器,如电磁辐射测试仪。

测试时,将待测设备放置在测试仓内,然后通过测试仪器测量辐射场强度。

根据不同国家的标准要求,测量可以在不同频段和距离下进行。

四、安全性评估根据EMC辐射值标准,可以对电子设备的辐射水平进行安全性评估。

一般来说,电子设备的辐射值应低于规定的限值,以确保对人体健康的潜在影响在可接受范围内。

如果辐射值超过限值,需要采取相应的措施进行辐射防护或改进设备设计。

五、结论EMC辐射值标准是衡量电子设备辐射水平的重要指标,对保护公众健康具有重要意义。

通过测量辐射值并进行安全性评估,可以确保电子设备在正常使用时不对人体健康造成潜在伤害。

因此,制定和遵守EMC辐射值标准对于电子设备的生产和使用具有重要意义。

六、参考文献[1] EMC Measurement Guidance Note, National Measurement Office, UK[2] Electromagnetic Compatibility and Radio Spectrum Matters (ERM), European Telecommunications Standards Institute。

IEC标准中的EMC测试要求介绍

IEC标准中的EMC测试要求介绍

05/01/99
Standards 6
3
R
The European Single Market
• This changed with the introduction of the single market in Europe • Individual member countries’ legislation was seen as a potential barrier to trade • The EEC directive on EMC was intended to give one standard for all of Europe
05/01/99 Standards 6 8
R
United States
FCC Part 15
– Legal requirement for all ITE equipment – Emissions only – Tests can only be performed in FCC approved laboratories
• Standards are produced by Standards Australia.
• C-Tick Mark is used to denote compliance with EMC standards
05/01/99 Standards 6 16
R
Not Only Legislation
05/01/99
Standards 6
9
R
Japan
• Voluntary standards under the VCCI scheme have existed in Japan since late 1985. • VCCI covers data processing and office automation equipment. • Although voluntary, VCCI is very strongly supported in Japan. • General movement towards adopting IEC standards.

EMC检验的送检要求及说明

EMC检验的送检要求及说明

EMC检验的送检要求及说明EMC检验的送检要求及资料说明⼀、送检清单1、送检样品及附件;2、覆盖型号申请、覆盖样机及产品差异表(申请产品型号覆盖时提供):3、医疗器械注册产品标准或技术要求;4、承诺书;5、使⽤说明书和技术说明书(出具中⽂报告提供中⽂版本,出具英⽂报告提供英⽂版本);6、*电路图;7、*样品连接图;8、*EMC检测报告(进⼝产品适⽤);9、*风险分析报告;10、*EMC关键元器件相关证书;11、产品相关资料表格(申请国内注册提供中⽂版本,申请出⼝认证提供英⽂版本):表1. 样品的适⽤范围;表2. 样品的⼯作频率、⽣理模拟频率和响应时间;表3. 样品的信息;表4. 样品的构成表5. 样品运⾏模式;表6. 产品电缆信息;表7. 样品骚扰源;表8. EMC关键元器件清单。

注1:以上资料需提供纸质版,并盖章。

注2:带*资料为可选项,根据具体产品情况提供。

⼆、关于提供EMC送检所需资料的说明1、送检样品主机⼀台,附件包括产品配套使⽤的患者电缆、互连电缆、脚踏开关、适配器、显⽰器、电脑、测试软件等。

当送检产品为医疗器械附件时(如有创⾎压传感器、⾎氧探头等),企业应提供符合电磁兼容标准要求的主机和辅助设备。

2、当送检产品有覆盖型号时应提供覆盖申请,说明主检型号与覆盖型号的差异,并提供所有覆盖型号的样机。

覆盖型号差异表样式见“三、承诺书、覆盖型号差异表及产品相关资料表格”。

以下情况不允许覆盖:a.按产品种类划分,种类不同的产品不能互相覆盖;b.按产品⼯作原理划分,⼯作原理不同的产品不能互相覆盖;c.按影响产品电磁兼容性的关键件划分,关键件、印刷电路图、电⽓结构不同的产品不能互相覆盖;d.同⼀商标、同⼀规格型号的产品,由不同产地⽣产的不能互相覆盖;e.台式设备与落地式设备之间不能互相覆盖。

3、申请中⽂报告检验时,医疗器械注册产品标准中应包含电磁兼容性的条款信息,英⽂报告不需要提供。

根据国家规定不再要求企业提供注册产品标准时,企业只需提供技术要求,技术要求中应包含电磁兼容性的信息。

emc调节方法

emc调节方法

emc调节方法English:EMC (electromagnetic compatibility) is the ability of electronic equipment to operate properly in the presence of electromagnetic interference, and to not emit electromagnetic interference that could interfere with other equipment. There are several methods to regulate EMC, including proper design and shielding of electronic devices to prevent interference, testing and certification of electronic equipment to ensure compliance with EMC standards, and using filters and suppression components to reduce electromagnetic interference. Additionally, proper grounding and routing of signal and power cables can help minimize electromagnetic interference. It is important for manufacturers of electronic equipment to adhere to EMC regulations to ensure their products do not cause or suffer from electromagnetic interference, and to protect the overall integrity and functionality of electronic systems.中文翻译:EMC(电磁兼容性)是电子设备在电磁干扰的情况下正常运行的能力,以及不发出可能干扰其他设备的电磁干扰。

EMC Standards (1)

EMC Standards (1)

US/CA EMC standards introduction
USA FCC (Unintentional) Part 15 Subpart B (Digital Device) FCC (Intentional) Part 15 Subpart C 15.227 (26.96MHz27.28MHz) 15.231 (間接性發射) 15.247 (展頻) 15.249 (非展頻-2.4GHz) Part 15 Subpart E ICES-003 (Digital Device) Canada IC (Unintentional) IC (Intentional) RSS-210 6.2.2 (o) (展 頻) RSS-210 6.1 (間接性 發射) RSS-210 6.2.2 (m2) (非展頻-2.4GHz)
Page 11
Antenna Requirement 天線要求 Restricted Bands of Operation 限制頻段 Conducted Limits 故意輻射 – 傳導干擾 Radiated Limits 故意輻射 – 輻射干擾 操作頻率 : 26.96 – 27.28MHz Ex. Wireless Keyboard, Wireless Mouse…. 操作頻率 : 40.66 – 40.70MHz and above 70MHz Ex. 15.231 Remote Controller 15.247 操作頻率 : 902 – 928MHz, 2400 – 2483.5MHz and 572557255875MHz Ex. Wireless LAN, Bluetooth… 操作頻率 : 902 – 928MHz, 2400 – 2483.5MHz and 5725572515.249 5875MHz Ex. Video Sender…

上衣各部位名称和常用的量度文法

上衣各部位名称和常用的量度文法

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all//EMC Standards//EMC test and design The Impact of Emerging European Standards 、//Trends in EMC Testing of household appliance//智能型框架式断路器单片机系统的电磁兼容性分析//滤波器在抗EMI中的应用及发展//Selecting the Right Fabric-Over-Foam EMI Gasket//EMI Requirements in Japan//Electromagnetic Interference (EMI) Damage to Giant Magnetoresistive (GMR) Recording Heads //Evaluating the Nonmagnetic Shields//Explosion Protection—The New Approach in Europe//地线干扰与抑制//超大规模集成电路中的可靠性技术应用与发展//Medical EMC Standards//Minimizing EMI from Heat Sinks//Mitigating EMI in High-Speed Digital Transmission Networks//Performing Safety Tests to Comply with the Low V oltage Directive//Product Safety Standards//Product Safety: Requirements and Methods//Terminology for electromagnetic compatibility//The FCC in Action to Address New EMC ConcernsBA TTERY//Advanced Battery Engineering Facility//An Analysis and Performance Evaluation of a Passive Filter Design Technique for Charge Pump PLL’s AN-1001//Introduction to Power Supplies//Don''t Throw A 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Equipment Industry//Automatic FMEA//Representation of Functional Relations among Parts and Its Application to Product Failure Reasoning//Design FMEA//FAILURE MODE AND EFFECTS ANALYSIS (FMEA)//FPU Failure Mode Effects and Criticallity Analysis//FAILURE MODE AND EFFECTS ANALYSIS IN MANUFACTURING AND ASSEMBLY PROCESSES//FAILURE MODE IDENTIFICA TION THROUGH CLUSTERING ANALYSIS//fmea di prodotto//FMEA TOOLS2//FMEA opdracht tuinsproeier//FMEA_Form//Failure Mode and Effect Analysis (FMEA) Packet//FLIGHT ASSURANCE PROCEDURE//fmea_presentation//Complying with the FMEA Requirements of the NewPatient Safety Standards//ANALISI DEI MODI E DEGLI EFFETTI DELLE A V ARIE//Risk –Informed Regulation of Marine Systems Using FMEA//Failure Mode and Effects Analysis//FAILURE MODES AND EFFECTS ANALYSIS (FMEA) WORKSHEET.//TOOLS OF RELIABILITY ANALYSIS -- Introduction and FMEAs//nasa fmea bibliography//Philips FMEA English//An Introduction to Risk/Hazard Analysis for Medical Devices//Using Failure Mode Effect Analysis (FMEA) to Improve Service Quality Service Operations Management//QUANTIFIED RISK ASSESSMENT TECHNIQUES (PART 1)//SURFACE VEHICLE RECOMMENDED PRACTICE//Scenario-based FMEA//PROCESS HAZARD ANALYSIS//software fmea//FMEA(umich)//FMEA(sverdrup)//using_failure_mode_and_effects_analysis_in_healthcare//Procedures for Assessing Risks//Incorporating a user-focused failure modes//DACTRON控制器簡介//包裝落下試驗機簡介//衝擊試驗機簡介//電磁式高頻振動試驗機//環境應力篩選隨機振動簡介//實驗室英文簡報資料//實驗室中文簡報資料//運輸型低頻振動試驗機//運輸型低頻振動試驗機//Ntuw_C防爆加热干燥烘箱//Hot Air Steriliser_C热空气消毒烘箱//TU 60_C干燥加热烘箱//Vht_C真空干燥箱//VTF_C洁净加热干燥烘箱//Vtl_C加热干燥烘箱//英国华莱氏公司产品浏览//BioLine V3.0_C_2003植物生长试验箱//Company Presentation V3.0_C_2003德国富奇介绍//Human Performance Testing V3.0_C_2003人体资源测试//IEC60068-3-5温度变化率//IP-Overview_C工业防护//Pharma V3.0_C_2003制药工业的药品稳定性试验//SC_C_2003阳光模拟试验箱//Thermalshock_C_2003温度冲击试验箱//V . T S C H - Climatic Test Cabinet 德国富奇公司-气候试验箱VC4018C //VP_C_2003药物稳定性试验//Vsc_C_2003盐雾试验//Vtsvcs_C_2003快速温度变化试验箱//Vtvc_detail_C_2003高低温试验箱//Vtvvcv_C_2003振动和更多的……//WALK_IN_APP步入式试验室//Walkin_C_2003步入式模拟环境试验室CD2Enviroment//How reverb chambers work//Chamber Temperature Uncertainty Analysis of the Thunder Scientific Model 2500 Two-Pressure Humidity Generator//Uncertainty_Analysis Thunder Scientific//SERIES 2500 BENCHTOP TWO-PRESSURE HUMIDITY GENERA TOR//About Temperature//Chamber Study//Circut enviroment test//Customers Seeking Environmental Testing//Enviroment test condition//environmental//HASS, HALT and ESS for electronics production//humidity temperature//TEMPERA TURE & HUMIDITYANDFAILURE ANALYSISBYRE ENVIRONMENT TEAM//Relative Humidity....Relative to What?//Introduction of temperature measure//Introduction of ThermalGGT/RE – Environment Test Team//USING THERMAL SHOCK//非密封性分系统热循环试验中的防结露问题//环境应力筛选有关问题的探讨//加速试验//热力学//温度试验中断处理的依据ESS//2002年度《RAMS》论文目录//国外CALS近期发展动态综述//国外CALS近期发展的三个新特点//CSP封装产品在热应力循环条件下的可靠性分析//环境应力筛选(ESS)//ESS//ESS_Fixture//《通信设备可靠性通用试验方法》YD/T 282-2000行业标准介绍//GJB150_19//HALT& HASS//国际电工委员会IEC/TC56(可信性技术委员会)颁发的“可信性”国际标准//Improper_ESS//Improper_ESS_part_2//MANAGING QUALITY//Managing Reliability and Maintainability (R&M)//quality and reliability//reliability develop//reliability training//以可靠性为中心的维修发展动态//SAE RCM标准的制订背景//Software Support Life Cycle Process Evaluation Guide//测试污染对测试结果的影响//测试技术要满足工程项目需求//Audit Report AA 00-341 High Level Architecture//Audit Report AA 01-128 Integrated System Control//Audit Report AA 01-23 Simulation High Level Architecture//Managing Reliability and Maintainability//Guidance on in-Service Reliability and Maintainability (R&M)//Intraoperability and Interoperability of Marine Corps Tactical C4I Systems//AF Instruction 33-133 Joint Technical Architecture -- Air Force//Promulgation of DOD Policy For Assessment, Test, and Evaluation of Information Technology System Interoperability//Compatibility, Interoperability, and Integration of Command, Control, Communications, and Computer (C4) Systems//Design Interface//Life Cycle Logistics Support and Materiel Fielding Process Technical Manual//Life Cycle Logistics Support and Materiel Fielding Process Technical Manual2//概率-物理方法——可靠性研究的新技术//环境应力筛选有关问题的探讨FMEA//01_fmea_example//failure analysis of semiconductor devices//FMEA1//FMEA Analysis Guidelines//潜在失效模式及后果分析//TOOLS OF RELIABILITY ANALYSIS -- Introduction and FMEAs//FMEA2//FMEA3//FMEA失效模式和效果分析//how to selling_root_cause to management//Philips FMEA//Potential Failure Mode and Effects Analysis//Random-Failure-Models/ROOT CAUSE ANALYSIS//root causea nalysis chapter1//SURFACE VEHICLE RECOMMENDED PRACTICE//WHA T MAKES A ROOT CAUSE FAILURE ANALYSIS PROGRAM SUCCESSFUL //故障模式影响分析//如何進行失效模式與影響分析ESD//Digital Phosphor Oscilloscopes//A Safety Standard for Electrosensitive Protective Equipment//Adding V alue through Accredited Testing//Littelfuse Cable Protectors for High Current Applications//CMOS集成电路的ESD设计技术//computer ESD solution//Fundamentals of Electrostatic Discharge An Introduction to ESD//ESD Suppression Technologies//ESD Suppression Technologies ec622a ec622a//Selecting an ESD Suppressor//ESD Protection Audio Input and Output Lines//Capacitance and Signal Integrity//ESD Protection Digital Visual Interface Data Lines//ESD Protection IEEE 1394 Data Lines//ESD Protection USB 1.1 Data Lines//ESD Protection USB 2.0 Data Lines//ESD Protection Video Input and Output Lines//General Purpose ESD Protection//ESD Journal - The ESD & Electrostatics Magazine//ESD protect//ESD Standards//Evaluation of Materials for Cleanliness and ESD Protective Properties//Electrostatic Discharge (ESD) in Magnetic Recording Past, Present and Future//Explosions and ESD//From Electrostatics to ESD//Fuse fact//Ground planes for low cost boards//Grounding Strategies for Printed Circuit Boards//How Is Static Electricity Generated//Is Static Electricity Static//Littelfuse Resistors for V oltage Suppression//SiV a ESD Demo//The Competitive Advantage of Standards//The Evolution of Guide into ISO 17025//What It Means to ESDHALT//ENVIRONMENTAL EFFECTS//笔记本电脑失效模式分析表//测试前笔记本性能测试//测试前后的机构电性功能验证//常见失效模式一览表//可靠性验证测试//失效分析是指研究产品潜在的或显在的失效机理//失效效应危害度一览表//ENVIRONMENTAL ENGINEERING CONSIDERA TIONS AND LABORA TORY TESTS//A fundamental overview of accelerated-testing analytic models//A5 P-FMEA//accelerated and classical reliability methods integrated//accelerated model//accelerated test reference1//accelerated test reference2//accelerated test reference3//accelerated test reference4//美国可靠性强化试验技术发展点评//An approach to designing accelerated life-testing experiments//Ast//BCC-4V Halt Test//Critical Analysis Team Report on Accelerated Waste Retrieval Final Design and Fixed Price Contracting//Don’t Let the Cost of HALT Stop Y ou//电子设备的可靠性设计技术//FEMMA Technology Overview FEMMA Technology Overview/fixturing China presentation 2-04//FMEA5//HALT & HASS1//HALT GUIDELINE 2004//HALT Guideline//HALT HASS SEMINAR PRESENTED BY ENVIROTRONICS//The Application of HALT for Increased Product Reliability//加速试验综述//HALT&HASS基础篇- 中文- 2003//HALT-HASS//HALT-Testing With a Different Purpose//Hass and Halt//HASS of Products With V ery Low Failure Rates//high reliability challenge of broadband equipment//Highly Accelerated Life Testing//紧凑型节能灯寿命的常规试验方法//Material failure mechanisms and damage models//MTBF Assurance test//PCB relia design//Quick guide Accelerated Life Testing Data Analysis Basics//quick guide life data analysis//可靠性设计//Reliability Glossary//reliability prediction VS HALT testing//Searching for appropriate humidity accelerated migration reliability tests methods//System reliability modeling considering the dependence of component environmental influences //understanding accelerated life testing analysis//what is HAST testing//why HALT cannot produce a meaningful MTBF number and why this should not be concern//高加速寿命试验(HALT)与高加速应力筛选(HASS)//失效率//用高压锅做测试//统计知识//概率与统计入门研究。

戴尔网络S4148F-ON产品符合性说明书

戴尔网络S4148F-ON产品符合性说明书

Product Compliance DatasheetMARKETING NAME...........Dell Networking S4148F - ON REGULATORY MODEL (20)REGULATORY TYPE………E20W003EMC EMISSIONS CLASS….AEFFECTIVE DATE……….…September 12, 2017Table of contentsI.Statement of Compliance (2)II.Power Cords and User Documentation (2)III.Trade (Import/Export) Compliance Data (2)IV.Product Dimensions and Weight (3)V.Product Materials Information (3)VI.Packaging (4)VII.Batteries (5)VIII.D esign for Environment (5)IX.Recycling / End-of-Life Service Information (5)X.Helpful Links (5)I. Statement of ComplianceThis equipment has been determined to be compliant with the applicable standards, regulations, anddirectives for the countries where the equipment is marketed. The equipment is affixed with regulatorymarking and text as necessary for the country/agency. Dell manufacturers and markets MultimediaEquipment (MME), Information Technology Equipment (ITE), Audio Visual Equipment (A/V), Industrial,Scientific, Medial Equipment (ISM) or combinations of these. Generally, equipment Safety and EMCcompliance is based on International IEC and CISPR standards and their national equivalent along withnational standards for Radio (wireless), and Energy. Dell products have been verified to comply with the EU RoHS Directive 2011/65/EU. Dell equipment does not contain any of the restricted substances inconcentrations and applications not permitted by the RoHS Directive. EMC Emissions Class refers to one of the following use environments:• EMC Class B equipment is intended for use in residential/domestic environments but may also be used in nonresidential/non-domestic environments.• EMC Class A equipment is intended for use in non-residential/non-domestic environments. Class Aequipment may also be utilized in residential/domestic environments but may cause interference and require the user to take adequate corrective measures.For Safety and EMC compliance, this equipment has been assigned a unique regulatory model andregulatory type that is imprinted on the equipment regulatory labeling to provide traceability to the regulatory approvals noted on this datasheet. This datasheet applies to any equipment that utilizes the assignedregulatory model and type including marketing names other than those listed on this datasheet. ErPcompliance is tied to the CE mark. REACH (Registration, Evaluation, Authorization and Restriction ofChemicals, 1907/2006) is the European Union’s (EU) chemical substances regulatory framework. Dellcomplies with the REACH directive. For information on SVHC (Substances of Very High Concern), see/REACH. Compliance documentation, such as certification or Declaration of Compliance for the equipment is available upon request to ***************************. Please include equipment identifiers such as marketing name, regulatory model, regulatory type and country that compliance information isneeded in request.II. Power Cords and User DocumentationDell products are provided with the power cord and user documentation suitable for the intended country of delivery. Products that are relocated to other countries should use nationally certified power cords and plugs to ensure safe operation of the product. Contact Dell to determine if alternate power cords or userdocumentation in other languages is available for your market.III. Trade (Import/Export) Compliance DataFor any questions related to importing & exporting classification of Dell products, please obtain information from the following link: /import_export_compliance or send request to*****************************.IV. Product Dimensions and WeightV. Product Materials InformationInformation on Dell’s material use is available here.Dell’s Restricted Material for Use guidance document is available here.The case material is, > T=1.0+- 5% JJIS G3302 SGCC – Z08<This product contains x% post-consumer recycled plastic/closed loop recycled plastics(Measured as a percentage of total amount of plastic (by weight) in the product as per guidance in EPEAT standard as applies to plastics parts)Flame Retardants Used in MotherboardFlame Retardants Used in Mechanical Plastic Parts > 25 grams1Mechanical plastic part: plastic parts that do not internally carry an electrical signal such as housings, brackets, bezels, latches, etc. that form the basic structure of the product and/or have mechanical functions. Plastic parts such as fans, connectors, printer fuser assemblies, etc. are not considered “mechanical plastic parts” in the context of this specification.Plastics parts do not contain no more than 0,1% weight (1000 ppm) bromine and 0,1% weight (1000 ppm) chlorine attributable to brominated flame retardants, chlorinated flame retardants, and polyvinyl chloride (Per Dell Spec ENV0424)2Dell will adopt the BFR/CFR/PVC-free definition as set forth in the "iNEMI Position Statement on the Definition of 'Low-Halogen' Electronics (BFR/CFR/PVC-Free)." Plastic parts contain <1000 ppm (0.1 percent) of bromine (if the Br source is from BFRs) and <1000 ppm (0.1 percent) of chlorine if the Cl source is from CFRs, PVC or PVC copolymers. All printed circuit board (PCB) and substrate laminates contain bromine/chlorine totaling less than 1,500 ppm (0.15 percent), with maximum chlorine of 900 ppm (0.09 percent) and maximum bromine of 900 ppm (0.09 percent)Mercury InformationRoHS and REACH declaration - see product material information section at:/environmental_informationProducts MSDS (Material Safety Data Sheets):Batteries: Battery MSDS Documentation and DeclarationPrinter Toner and Ink: MSDS DocumentationVI. PackagingInformation on Dell’s sustainable packaging effort available here.3 Non-wood, biobased material may include, but is not limited to: bagasse, bamboo, mushroom, straw, agricultural waste or byproduct. * Recycled content in packaging material is supplier dependent.VII. BatteriesVIII. Design for EnvironmentDell systems are, when applicable, designed for easy assembly, disassembly, and servicing.For more information on product Recyclability please visit /environmental_information IX. Recycling / End-of-Life Service InformationTake back and recycling services are offered for this product in certain countries. If you want to dispose of system components, please visit /recyclingworldwide and select the relevant country. X. Helpful LinksEnvironmental Policy/sites/content/corporate/corp-comm/en/Documents/dell-global-environmental-policy.pdfEnvironment Website/environmental_informationCorporate Sustainability Report/Learn/us/en/uscorp1/report?c=us&l=en&s=corp&delphi:gr=trueISO 14001 Certification/sites/content/corporate/corp-comm/en/Documents/dell-iso14001-worldwide.pdfMaterials Restricted for Use/downloads/global/corporate/environ/restricted_materials_guid.pdfChemical Use Policy/sites/doccontent/corporate/environment/en/Documents/chemical-use-policy.pdfProduct Carbon Footprint/us/en/corp/d/corp-comm/environment_carbon_footprint_productsRoHS Compliance/rohsinfoREACH Compliance/REACHRecycling Information/recyclingSupplier Responsibility/us/en/corp/d/corp-comm/standards-for-suppliers.aspx。

产品认证安规及EMC相关知识简介

产品认证安规及EMC相关知识简介

指令与标准是不同的概念,一个指令可以有很多个相应的 协调标准来对应不同的产品以进行测试。
而一个产品,有时候可能同时受多个指令覆盖,这时就要 满足有关指令的规定擦可以加贴CE标志。例如,我们的产 品不仅受93/42/EEC医疗器械指令覆盖,同时也受 89/336/EEC电磁兼容指令覆盖,这时就要同时满足两项指 令才可以施加CE标志。
guidance for alarm systems(报警系统勘察与引导) 。
(1)EN60601-1-6
根据新版之人因设计概念,制造厂商必须在设计过程中遵 照人因设计理念,理清【可以预见的错误使用原则】,设 计回避发生使用错误的方法,如果危险的风险无法降到可 以合理被接受的范围内,则必须以伴随文件标示告知或警 告使用人,如果操作使用人不理会造成可以遇见错误使用 的危害,根据IEC60601-1-6非制造商应该履行的责任。
(二)新版标准的重要理念
旧版适用范围:病患 诊断/治疗/监视 新版延伸范围:补偿或轻缓 疾病/伤害/残障
1、安全的共识
设计者应理解并避免下列各种状况 病患或操作人无能力察觉某些潜在危险时
病患因无行动能力、无意识等丧失正常反应时
病患的皮肤阻抗丧失正常防卫电流能力时
当医疗设备支持或取代身体的生命功能时,医疗设备将 依赖其【可靠度】以保障安全时
在新版标准里采用风险管理概念设计,制造厂商可以根据 【安全等同原则】,只要根据风险管理计划中的管理分析 结果,能够证明其残余风险等同或低于既有方法,使用资 讯产业零组件(即符合EN60950-1)同样可以被接受。
新版标准对于必须接触病患身体的设备【触身部分】,采 用图例解说的方式作较为严谨的定义。
2、机械性安全
(三)新版标准的概念
设计医疗设备电性安全的决策优先顺序为:性能标准、产 品标准、附属标准以及一般标准。
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EMC Standards and Their Application By Dag BjörklöfETL SEMKO (Kista, Sweden)Intertek Testing ServicesWithout EMC—no market access! Yes, that is the fundamental concept for manufacturers of electrical apparatus and systems to remember. It is therefore necessary to stay current on EMC requirements and standards and to try to understand how each applies to different types of equipment.Regulations may be mandatory, like U.S. FCC requirements and European EC Directives, or voluntary, like VCCI approval in Japan. In either case, following EMC regulations may impart a market advantage.Standards are voluntary to use but are recommended as a reference for verification of compliance with regulations. Basic standards describe test procedures, and in some cases test instrumentation and calibration techniques, while more specific product or application standards usually define limits, severity levels, and compliance criteria. This article provides an overview of EMC standards and their use for verifying compliance with regulations. Electromagnetic Compatibility—Some Fundamental Concept sEMC stands for electromagnetic compatibility and is defined as the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable disturbances to anything in that environment. EMC requirements concern two basic concepts: emissions and immunity or susceptibility.Electromagnetic disturbance is any phenomenon that may degrade the performance of a device, equipment, or system, or adversely affect living or inert matter.Electromagnetic interference (EMI) is the degradation of the performance of a device, transmission channel, or system caused by an electromagnetic disturbance. In certain parts of the world, "EMI" is used to characterize emissions. This may lead to confusion when it comes to the characterization of immunity, which is sometimes called EMC!Electromagnetic disturbances can be conducted or radiated, and the emissions and immunity requirements are referred to in military standards (MIL-STD 461/462) as CE/RE (conducted emission/radiated emission) and CS/RS (conducted susceptibility/radiated susceptibility), respectively. Disturbances may represent low-frequency (LF) and/or high-frequency (HF) phenomena, as well as broadband and/or narrowband. Broadband disturbances can originate from commutator motors, ignition systems, arcwelding equipment, etc.; narrowband from digital electronic circuitry, switched-mode power supplies, and radio communication equipment. Computers have often been reported to cause interference with radio services, including police, aeronautical and broadcast services. On the other hand, radio transmission by a high-frequency carrier, such as a 900 MHz cellular or a 1.8 GHz DCS, can cause problems in computers and all electrical circuits because the carriers are easily picked up by cables and apertures functioning as antennas and are demodulated in electronic circuits by different nonlinear electromagnetic phenomena.To really understand how electromagnetic disturbances emanate, propagate, and influence electrical systems, one must have a thorough knowledge of electromagnetic field theory and high-frequency phenomena. EMC represents a broad field of technology and may represent a new subject for many manufacturers of electrical products. However, if one follows certain rules of thumb regarding wiring, PCB layout, grounding and shielding, and usage of RFI suppression components, it is not difficult to cope with different EMC standards and regulations.In industry, it is assumed that electronic control systems can be used in conjunction with interfering switching operations, motor drives, high-frequency ovens, welding equipment, etc. In a car, electronic automatic systems must function when we use our mobile phone or meet other vehicles (with interferingignition systems). An electronically controlled wheelchair is presumed to function normally even when the person sitting in the chair uses a mobile phone or a portable PC. We demand that life-supporting electromedical apparatus in a hospital function safely even near high-frequency—radiating surgical equipment.U.S. RequirementsThe general EMC requirements in the U.S. are set by the Federal Communications Commission (FCC), while the Food and Drug Administration (FDA) regulates medical products. Mandatory FCC requirements primarily concern computing devices, defined as any electronic device or system that generates and uses timing pulses at a rate in excess of 9000 cycles per second and uses digital techniques. FCC Part 15 covers radio frequency devices capable of emitting RF energy in the range of 9 kHz—200 GHz. Testing should be done according to ANSI C63.4-1992.Part 18 covers industrial, scientific, and medical (ISM) equipment (Figure 1), defined as any device that uses radio waves for industrial, scientific, or medical purposes and is not intended for radio communications. While most FCC regulations only concern emissions, FDA also requires immunity for certain life-support equipment. FCC Parts 15 and 18 include regulations as well as technical aspects and limits. FCC Part 68, which governs the technicalrequirements for registration of telecom terminal equipment, includes lightning surge tests (surge immunity).Figure 1. Required frequency range ofradiated measurements—ISM.FCC Part 15 currently has three different procedures for showing conformance:∙Verification, where the manufacturer or the importer files a test report showing compliance.∙Certification, which requires a review of the application by the FCC, and the use of a unique FCC identification number.∙Declaration of Conformity (DoC), which requires that tests are performed by a test lab accredited by A2LA or NVLAP (other accredited labs may also be accepted).∙The following represents an example of the FCC's classification system, where the correct administrative procedure is listed according toproduct type (Class A refers to nonconsumer products, Class B toconsumer products):∙Personal computers and peripherals (Class B): Certification or DoC.∙Cpu boards and internal power supplies used with personal computers (Class B): Certification or DoC.∙External switching power supplies (Class A and B): Verification.The FCC is currently reviewing these procedures with the aim of simplifying them by reducing the number of categories.EU RequirementsThe European EMC Directive, 89/336/EEC, sets out the legal requirements on EMC for principally all electric/electronic equipment to be placed or used in the Common Market/European Economic Area. The European legislation covers emissions as well as immunity.The EMC requirements are valid for apparatus and systems placed on the market as complete units. Components such as resistors, transistors, or display units are not included. However, components with a direct function to the end-user, like plug-in PC boards, are regarded as equivalent to apparatus and have to follow the same rules (see Table I).Scope ofFCC EU EMCRegulation—Device TypesUnintentional Radiators Appliances and/ordigital circuitryinsideNo YesAutomotive digital electronics NoYes, Auto EMCDirectiveDevices with power<6 n WNo NoComponents No, except cpuboards andpower suppliesYes, if it has adirect functionElectromechanical No Yes, except for induction motorsKits No, except TV interface deviceYesFluorescent lamps, fixtures No (unless RF ballast)YesMarine digital electronics NoYes, MarineEquipmentDirectiveMedical digital devices No Yes, Active Implantable, or Medical Devices DirectivesTest equipment No Yes Controls in industrialplantsNo Yes Battery operated clock<1.705 MHzNo Yes Digital devices, PCs,peripheralsYes Yes Intentional RadiatorsAmateur radio transmitters No, exceptcommercialNo, except EMCfor commercialpower amplifiers transmittersShort-range devices Yes, Part 15ETS 300, 220, 328, 330, 440, 445, or national rulesHigh power transmitters Yes, other FCCPartsETSI or nationalrulesTable I. Scope of FCC and EU EMC regulations forunintentional and intentional radiators.New EEC Directives only set out essential requirements and legal aspects (New Approach). Technical aspects are dealt with in specific standards, the application of which is voluntary. These standards are developed by specific bodies, such as CENELEC or ETSI, and are harmonized to the directives by the action of the European Commission. The EMC Directive itself, however, is based on a presumption principle, which means that a product that meets the requirements of the harmonized standards is also presumed to meet the essential requirements of the EMC Directive.StandardizationUnder the General Agreement on Tariffs and Trade (GATT) and its successor, the World Trade Organization (WTO), member countries are obliged to adopt international standards for national use wherever possible. International standards concerning EMC are primarily developed by the International Electrotechnical Commission (IEC) and the International Special Committee on Radio Interference (CISPR). The new extensive series developed by IEC includesIEC 61000-1—Introduction, terms, and conditions.∙IEC 61000-2—Classification of electromagnetic environments.∙IEC 61000-3—Limits and disturbance levels.∙IEC 61000-4—Testing and measurement techniques.∙IEC 61000-5—Installation and mitigation guidelines.∙IEC 61000-6—Generic standards.Some specific EMC standards have also been published by the International Organization for Standardization (ISO). North American EMC standards are published by the FCC, the American National Standards Institute (ANSI), and the Institute of Electrical and Electronics Engineers (IEEE). Private standards are submitted by Bellcore (for telecom equipment), the Society of Automotive Engineers (SAE) and automotive manufacturers, and the U.S. Department of Defense.European EN standards concerning EMC are developed by the European Committee for Electrotechnical Standardization (CENELEC).Regulations and standards concerning telecom and radio transmitting equipment are published by the International Telecommunications Union (ITU) and the European Telecommunications Standards Institute (ETSI). International and European EMC standards are to a great extent becoming harmonized, due to the fact that many EN standards are based on IEC and/or CISPR standards. There are also similarities between international and U.S. standards, though they are not equivalent. Figure 2 shows some intercompatibility problems between similar emission standards (FCC Part 15 J and CISPR 22 limits, respectively, measured at a distance of 10 m). FCC,however, accepts conformity to CISPR 22: 1985 as an alternative to FCC Part 15 (sections 15.107 and 15.109).Figure 2. Emission limits compared at ameasuring distance of 10 m.Figure 3. Required frequency range ofconducted measurements.EMC standards are continuously being developed and revised, and the standards "jungle" sometimes seems a bit difficult to get through. It is therefore important to keep track of standards' publication dates, in addition to knowing if a new standard is to be expected in the near future and when an old standard is no longer valid. The following dates are of specific interest in regard to a standard: date of publication (dop) and date of withdrawal (dow) of a conflicting(earlier) standard. Draft standards are sometimes called preliminary, for example prETS or prEN. Temporary EN standards are called ENV.Standard RequirementsStandards are principally divided into the following main groups:Generic/General StandardsGeneric standards refer to the electromagnetic environment in which the apparatus/system is to be used. General standards concern groups of equipment used for general applications in a specific environment, like general telecom equipment and medical and laboratory equipment.Basic StandardsBasic standards describe measuring methods and, in some cases, interference levels as well as limits. One of these is the standard series IEC 801-X for process industrial applications, which has been converted into a general series of basic standards, IEC 61000-4-X, which were then translated into European standards as EN 61000-4-X.Product and Product Family StandardsThese are applicable for specific product types, which are specified within the scope of the standard.In addition to these standard documents, there are also standards offering guidance on installation techniques, or a code of practice, for example the IEC 61000 series, Part 5 (IEC 61000-5-X).EMC Standards ClassificationGeneric standards have two environmental classes:1. Residential, commercial, and light industrial environments, including domestic, office, laboratory, and light industrial environments where the apparatus or system is connected to the public mains.2. Industrial environments, meaning "heavy" industrial environments with separate transformer stations for mains supply, usually with equipment spread over some distance.This simplified view of the world as one of two categories does not hold true in all cases. There are so-called gray zones such as laboratory or hospital environments where equipment may be connected either to the public mains or to an in-house power net, through a separate transformer station.CISPR standards concerning emissions, and to some extent corresponding EN standards, have a classification according to the following:Class B/CISPR 22Information Technology Equipment (ITE) intended primarily for use in domestic environments and may include portable equipment, telecommunications terminal equipment, personal computers, and auxiliary connected equipment. Class A/CISPR 22ITE, which satisfies Class A but not Class B limits.The following warning shall be included in the instructions for use: This is a Class A product. In a domestic environment this product may cause radio interference, in which case the user may be required to take adequate measures.Class B/CISPR 11ISM equipment suitable for use in domestic establishments and in establishments directly connected to a low-voltage power supply network. Class A/CISPR 11ISM equipment suitable for use in all establishments other than domestic and those directly connected to a low-voltage power supply network.The emission limits differ 10 dB between Class A and Class B equipment, as well as between the generic emissions standards for the "light" and "heavy"environments, respectively, when referred to the same measuring distance. When recalculated from 10 to 3 meters distance, there is a difference in radiated emissions of 9.5 dB. It should also be noted that the classification of computing devices according to FCC 15, and ISM equipment to FCC 18, is very similar to that of CISPR 22 and CISPR 11 Group 2.Which Standards Apply?A product standard is one that covers all EMC requirements for a certain product type. In some cases, product standards also cover electrical safety requirements. A product standard takes preference over all other standards. Once it is determined that a product is within the scope of an applicable product family standard concerning emissions and/or immunity, then that standard should be followed. Some examples of family standards include ∙CISPR 11/EN 55011 Emission standard for industrial, scientific, and medical (ISM) radio RF equipment (see Figure 3).∙CISPR 12 Emission standard for vehicles, motorboats, and spark-ignited engine-driven devices.∙CISPR 13/EN 55013 Emission standard for broadcasting equipment like radio, television, etc.∙CISPR 14/EN 55014 Emission standard for household apparatus and portable tools.∙CISPR 15/EN 55015 Emission standards for luminaires.∙CISPR 20/EN 55020 Immunity standard for broadcasting equipment, such as radio and television.∙CISPR 22/EN 55022 Emission standard for information technology equipment (ITE).∙CISPR 24/EN 55024 Immunity standard series for ITE.Newer product family standards also tend to appear as complementary emissions and immunity standards:∙EN 55014-1, EN 55014-2 Emissions and immunity requirements for household apparatus and portable tools.∙EN 55103-1, EN 55103-2 Emissions and immunity requirements for professional audio and video equipment.Specific types of product family standards transferred into general standards include:∙IEC 555-2/EN 60555-2 LF emissions standard concerning harmonics for household products, etc.∙IEC 555-3/EN 60555-3 LF emissions standard concerning flicker and voltage variations for household products, etc.∙IEC 61000-3-2/EN 61000-3-2 General LF emissions standard concerning harmonics.∙IEC 61000-3-3/EN 61000-3-3 General LF emissions standard concerning flicker and voltage variations.Today, however, very few pure product standards exist that cover all requirements. Therefore one has to look for an applicable product family standard. An additional complication is that, for the time being, a product can sometimes belong to different product family standards. For example, most household devices must fulfill emissions requirements according to EN 55014-1, as well as EN 60555-2 and EN 60555-3 or EN 61000-3-2 and EN 61000-3-3.Generic/General StandardsIf no product family standard is applicable, one must follow the suitable generic or general standard, which in turn refers to different basic standards. Some of the product family standards are also referred to in other standards, which consequently gives them characteristics of basic standards.The generic standards include:∙EN 55081-1 Emissions standard for residential, commercial, and light industrial environments.∙EN 55081-2 Emissions standard for industrial environments.∙EN 55082-1 Immunity standard for residential, commercial, and light industrial environments.EN 55082-2 Immunity standard for industrial environments.The IEC is also developing corresponding generic standards, which will be numbered IEC 61000-6-X. A general EMC standard that covers emissions and immunity for medical equipment is EN 60601-1-2, the collateral standard for medical equipment. In addition to this collateral standard, there are a number of product standards covering safety and EMC for specific medical equipment, like EN 60601-2-24, which covers infusion pumps and controllers.A general EMC standard that covers emissions and immunity for TTE equipment is ETS 300 339 (general standard for radio transmitting equipment). In addition to this standard, there are a number of ETS/prETS standards covering EMC for different telecom and radio transmitting equipment.As far as the emissions requirements are concerned, the generic standard is more rigorous in regard to light industrial environments than on heavy industry, which as a rule is already rather electromagnetically contaminated. As far as the immunity requirements are concerned, the situation is the opposite. Interference immunity must be hardier in heavy industrial environments.What then is applicable in mixed or special environments? When using the generic standards it is recommended to begin with the most strict requirements, which means that the equipment should be classified according to the "worst"combination, such as EN 50081-1/EN 50082-2. This scenario has sometimes been used for equipment in hospital environments.Basic Immunity StandardsThe IEC standardization committee for industrial processing techniques, TC 65, drafted the first basic standards for immunity to electrical disturbances. This responsibility has been taken over by the committee that works with general EMC standards, TC77 (IEC) and TC 210 (CLC). With this, the publication numbers changed from IEC 801 to IEC 1000/61000 and EN 61000, and thus far the disturbance types that have been dealt with have gone through the following changes:1. Electrostatic discharges (ESD).∙IEC 801-2, ed. 1.∙IEC 801-2, ed. 2=IEC 61000-4-2=EN 61000-4-2.2. Radiated, radio frequency electromagnetic fields (RF fields).∙IEC 801-3.∙ENV 50140~IEC 61000-4-3=EN 61000-4-3.3. Electrical fast transients/burst (EFT).∙IEC 801-4.∙IEC 61000-4-4=EN 61000-4-4.4. Surges (1, 2 µs/50 µs).∙ENV 50142~IEC 61000-4-5=EN 61000-4-5.5. Immunity to conducted disturbances induced byradio frequency fields.∙ENV 50141~IEC 61000-4-6=EN 61000-4-6.6. Immunity to magnetic fields.∙IEC 61000-4-8, IEC 61000-4-9, and IEC 61000-4-10=EN 61000-4-8, IEC 61000-4-9, and IEC 61000-4-10.7. Voltage dips, short interruptions, and voltage variations.∙IEC 61000-4-11=EN 61000-4-11.Because some generic standards and some product standards have been published at the same time as the aforementioned revised standards, we will have to live with references to new, as well as old, basic standard versions for some time.ConclusionEMC regulations will be successively refined. We are going to see a whole series of new standards and amendments during the next few years. In many cases new standards will mean increased testing requirements. And while these testing requirements might not be welcomed by all manufacturers, they will benefit the end-users of electrical equipment.。

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