Establishment of paternity testing system using microsatellite markers in Chinese Holstein
农药登记试验单位质量保证人员管理培训
英文回答：The provision of training for quality assurance personnel responsible for pesticide registration test units is of paramount importance in ensuring the safety and efficacy of agricultural pesticides. Theprehensive training program must epass a wide array of subjects, including the fundamental principles and regulations governing pesticide registration, the effective management of test units, rigorous quality assurance procedures, as well as ethical considerations pertinent to conducting pesticide trials. Practical exercises and case studies should also form an integral part of the training, facilitating the practical application of the knowledge and skills acquired by participants.对负责农药登记检验单位的质量保证人员进行培训，对于确保农业农药的安全性和有效性至关重要。
全面的培训方案必须涵盖广泛的课题，包括农药登记的基本原则和条例、测试单位的有效管理、严格的质量保证程序以及与进行农药试验有关的道德考虑。
实践练习和案例研究也应构成培训的一个组成部分，为实际应用参与者获得的知识和技能提供便利。
CNAS国际认证有效性论证-中英文对照版
CNAS国际认可论证IAF是国际认可论坛IAF是国际认可论坛(International Accreditation Forum)的缩写，它是由有关国家认可机构参加的多边合作组织，成立于1993年1月，现有成员30多个，中国合格评定国家认可委员会(CNAS)是其成员单位之一，中国也是17个发起国之一。
其主要目标是协调各国认证制度，通过统一规范各成员国的审核员资格要求、培训准则及质量体系认证机构的评定和认证程序，使其在技术运作上保持一致，从而确保有效的国际互认，它在世界上包括两大组织，分别是欧洲认证认可组织(EAC)和太平洋认可合作组织(PAC)。
以认可项目等效性为基础，国际认可论坛多边承认协议签约的认可机构批准的认可，使组织持有在世界的某一地区已被认可的认证证书能在世界的任何地区被承认。
因此，被IAF多边承认协议签约认可机构认可的认证机构在管理体系、产品、服务、人员和其它类似的符合性评审项目所颁发的认证证书在国际贸易等领域均能得到世界各国承认与信任。
欧洲认证认可组织EAC欧洲认证认可组织EAC 始建于1991年，目的是在欧洲建立一个区域性的认可制度，实现对各成员国的认证机构能力的相互承认，从而达到对认证证书的相互承认。
EAC 的组成成员主要来自欧洲经济共同体和欧洲自由贸易联盟成员国的国家认可机构。
在各通过同行评定的加盟成员国认可机构间签署多边承认协议。
同行评定是指由各认可机构派代表组成联合审核组，依据ISO/CAS_CO226、ISO/CA8CO227及EN45012和 ISO/IEC48号指南对其他认可机构进行能力评审。
已签署协议的有：FINAS芬兰、RVC荷兰、NA挪威、SWEDAC瑞典、SAS瑞士、NACCB英国。
太平洋认可合作组织太平洋认可合作组织（Pacific Accreditation Cooperation, 英文缩写PAC），是由亚太经济合作组织（APEC）成员经济体的认证机构的认可机构或类似合格评定机构的认可机构及利益相关方组成的协会。
PaternityTesting
determining paternity? • Depends on:
– Number of markers genotyped – Heterozygosity of markers
Paternity Testing
Mendelian Segregation
Rules of Inheritance:
1) Child has two alleles for
each autosomal marker
A, B
C, D
(one from mother and one
from biological father)
A, D
2) Child will have mother’s mitochondrial DNA
haplotype (barring
mutation)
3) Child, if a son, will have father’s Y-chromosome haplotype (barring mutation)
(A)
Parentage (Paternity) Testing
Random man
Alleged
Mother
father (known parent)
Types of Kinship Testing:
?
child
(B)
Reverse Parentage Testing
(Missing Persons Investigation)
Figure 23.1, J.M. Butler (2005) Forensic DNA Typing, 2nd Edition © 2005 Elsevier Academic Press
质量管理常用英文单词图文稿
质量管理常用英文单词集团文件发布号：（9816-UATWW-MWUB-WUNN-INNUL-DQQTY-QM--quality management--质量管理quality manager质量经理QE--quality engineer--质量工程师QA--quality assurance--质量保证QC--quality control--质量控制IQC--incoming?quality control--进料检验Hf0U PQC--process quality control--制程检验FQC--finished quality control--成品检验OQC--outgoing quality control--出货检验-质量-SPC ,sixsigma,TS16949,MSA,FMEA(x^:sGjSQE--supplier quality engineer--供应商质量工程师六西格玛品质论坛QD9b-L-[| |QSE--quality system engineer--质量体系工程师AQE--assistant quality engineer--质量助理工程师:{#`8C3Sp.o h PQE--process quality engineer--过程质量工程师六西格玛品质论坛r CS--client server--客户服务PQC--process quality control--制程检验,,,,,,,,,improcessFQC--finished quality control--成品检验,,,,,,,,,final加上VQA--Vendor quality assurance--供应商质量保证parts per million，简称PPM}就是每百万坏品率少于3. H |-H+F1T5rI全面质量管理（TQM）质量一致性检验?inspecton of quality conformity仲裁性质质量监督?quality supervision for arbitration产品保护?product protection产品定型?product approval产品分等?product classificatin产品规范?product specification产品设计?product design产品质量?product quality产品合格率?product percent of pass产品系列化?product seriation产品管理标准?product management standard产品计量单位?unit of measurement of product产品售后服务?after service产品质量标志?product quality mark产品质量标准?product quality standard产品质量管理?product quality management产品质量检验?product quality inspection产品质量监督检验?product quality supervision and inspection产品质量认证标志?certification marking of product quality产品质量认证程序?certification procedure of product quality产品质量认证制度?certification system of product quality认证?certification立法?legislation自行认证?self-certification认可?accreditation安全认证?safety certification安全认证标志?mark of safety certification强制性认证?compulsory certificate实验室鉴定?laboratory qualification实验室认证?laboratory certification自愿认证制?voluntary system of certification法规机构?regulatory authorities认证活动?certification activity认证体系?certification system认证计划?certification scheme认证机构?certification body检验机构?inspecton body许可证?licence申请人?applicant许可证持有者?licensee合格证书?certificate of conformity合格标记?mark of conformity认证体系的利用?access to certification system认证体系的参与者?participant in certification system认证体系的成员?member of certification system批准?approval型式批准?type approval测试实验室的认可?accreditation of testing laboratory认可?accreditation认可体系?accreditation system认可机构?accreditation body认可的实验室?accredited laboratory认可准则?acreditatin criteria实验室评定?laboratory assessment实验室评定者?laboratory assessor认可的实验室的试验报告?accredited laboratory test report批准签署人?approved signatory承认和批准协议?recognition and approval arrangement承认协议?recognition arrangement单边协议?unilateral arrangement双边协议?bilateral arrangement多边协议?multilateral arrangemetn互利?reciprocity平等待遇?equal treatmetn国家待遇?national treatment国家和平等待遇?national and equal treatment合格及有关的通用概念?conformity and related general concept 合格?conformity合格测试?conformity testing合格?acceptable合格品?acceptable part合格标志?mark of conformity合格认证?conformity certification合格认证标志?mark of conformity certification合格品标志?mark of acceptable product合格证书?certificate of conformity合格证检查?inspection by certificate合格质量检查?acceptable quality level评定合格?assessment of conformity合格评定?conformity assessment型式评价?type evaluation合格监督?conformity surveillance合格证明?verification of conformity合格保证?assurance of conformity供货商声明?supplier's declaration生产许可证?production licence一致?consensus检验?inspection不定期检验?nonperiodic inspection抽样检验?sampling inspection出厂检验?exfactory inspection第一方检验?first party inspection第二方检验?second party inspection第三方检验?third party inspection第三方认证制度?third pary certification定期检验?periodic inspection交收检验?acceptance inspeciton例行检验?routine inspeciton生产检验?produciton inspeciton生产定型检验?production approval inspeciton验收检验?acceptance inspeciton验证检验?compliance test仲裁检验?arbitration inspection制造商担保?guarantee by manufacturer百分比抽样检查?percent sampling inspection不合格判定数?rejection number不合格质量水平?rejecton quality level抽查型质量监督?sampling quality supervision环境监测?environmental monitoring抽样?sampling多次抽样?multiple sampling分层抽样?stratified sampling分层随机抽样?stratified random smapling多级抽样?multistage sampling二次抽样?double sampling试件?test piece试验报告?test report试样?test sample测试设备?testing equipment测试试验室?testing laboratority商标?trademark商品名称?trade-name测试?testing试验?test实验室间的试验比较?interlaboratory test comparisons 熟练水平试验?proficiency testing次品?defective product代用产品?substitute product定量试验?quantitative test出口管理?export control出口许可证制度?export control进口许可证制度?import licence system定额管理?quota management非关税壁垒?non-tarrif barrier关税壁垒?tariff barrier关税普遍优惠制?general preferential dutiesCore value（核心价值）Love 爱心Confidence?信心Decision 决心Corporate culture(公司文化)Integration?融合Responsibility 责任Progress 进步3T STRATEGYTime to market?及时切入生产Time to volume?及时大量生产Time to money?及时大量交货FOUR CONTROL SYSTEM 四大管制系统Engineering control system 工程管制系统Quality control system品质管制系统Manufacturing control system生产管制系统Management control system经营管制系统7SClassification整理(sorting, organization)-seiri Regulation整顿(arrangement, tidiness)-seiton Cleanliness清扫(sweeping, purity)-seiso Conservation清洁(cleaning, cleanliness)-seiktsu Culture教养(discipline)-shitsukeSave 节约Safety安全二:英文缩写品质人员名称类QC quality control 品质管理人员FQC final quality control 终点品质管制人员IPQCin process quality control 制程中的品质管制人员OQC output quality control 最终出货品质管制人员IQC incoming quality control 进料品质管制人员TQC total quality control 全面质量管理POC passage quality control 段检人员QA quality assurance 质量保证人员OQAoutput quality assurance 出货质量保证人员QE quality engineering 品质工程人员品质保证类FAI first article inspection 新品首件检查FAA first article assurance 首件确认CP capability index 能力指数CPK capability process index 模具制程能力参数SSQA standardized supplier quality audit 合格供应商品质评估FMEA failure model effectiveness analysis 失效模式分析FQC运作类AQL Acceptable Quality Level 运作类允收品质水准S/S Sample size 抽样检验样本大小ACC Accept 允收REE Reject 拒收CR Critical 极严重的MAJMajor 主要的MIN Minor 轻微的Q/R/S Quality/Reliability/Service 品质/可靠度/服务P/N Part Number 料号L/N Lot Number 批号AOD Accept On Deviation 特采UAI Use As It 特采FPIR First Piece Inspection Report 首件检查报告PPM Percent Per Million 百万分之一制程统计品管专类SPC Statistical Process Control 统计制程管制SQC Statistical Quality Control 统计品质管制GRR Gauge Reproductiveness & Repeatability 量具之再制性及重测性判断量可靠与否DIM Dimension 尺寸DIA Diameter 直径N Number 样品数其它品质术语类QIT Quality Improvement Team 品质改善小组ZD Zero Defect 零缺点QI Quality Improvement 品质改善QP Quality Policy 目标方针TQM Total Quality Management 全面品质管理RMA Return Material Audit 退料认可7QCTools 7 Quality Control Tools 品管七大手法通用之件类ECN Engineering Change Notice 工程变更通知(供应商)ECO Engineering Change Order 工程改动要求(客户)PCN Process Change Notice 工序改动通知PMP Product Management Plan 生产管制计划SIP Standard Inspection Procedure 制程检验标准程序SOP Standard Operation Procedure 制造作业规范IS Inspection Specification 成品检验规范BOM Bill Of Material 物料清单PS Package Specification 包装规范SPEC Specification 规格DWG Drawing 图面系统文件类ES Engineering Standard 工程标准CGOO China General PCE龙华厂文件IWS International Workman Standard 工艺标准ISO International Standard Organization 国际标准化组织GS General Specification 一般规格部类PMC Production & Material Control 生产和物料控制PCC Product control center 生产管制中心PPC Production Plan Control 生产计划控制MC Material Control 物料控制DC Document Center 资料中心QE Quality Engineering 品质工程(部)QA Quality Assurance 品质保证(处)QC Quality Control 品质管制(课)PD Product Department 生产部LAB Laboratory 实验室IE Industrial Engineering 工业工程R&D Research & Design 设计开发部生产类PCs Pieces 个(根,块等)PRS Pairs 双(对等)CTN Carton 卡通箱PAL Pallet/skid 栈板POPurchasing Order 采购订单MO Manufacture Order 生产单D/C Date Code 生产日期码ID/C Identification Code (供应商)识别码SWR Special Work Request 特殊工作需求L/N Lot Number 批号P/N Part Number 料号OEM Original Equipment Manufacture 原设备制造PC Personal Computer 个人电脑CPU Central Processing Unit 中央处理器Soon As Possible 尽可能快的E-MAIL Electrical-Mail 电子邮件N/A Not Applicable 不适用QTY Quantity 数量I/O input/output 输入/输出NG Not Good 不行,不合格C=0 Critical=0 极严重不允许APP Approve 核准,认可,承认CHK Check 确认ASS'Y Assembly 装配,组装T/P True Position 真位度5WIH When, Where, Who, What, Why, How to6M Man, Machine, Material, Method, Measurement, Message4MTH Man, Material, Money, Method, Time, How 人力,物力,财务,技术,时间(资源)SQA Strategy Quality Assurance 策略品质保证DQA Design Quality Assurance 设计品质保证MQA Manufacture Quality Assurance 制造品质保证SSQA Sales and service Quality Assurance 销售及服务品质保证LRR Lot Reject Rate 批退率SPS Switching power supply 电源箱DT Desk Top 卧式(机箱)MT Mini-Tower 立式(机箱)DVD Digital Video DiskVCD Video Compact DiskLCD Liquid Crystal DisplayCAD Computer Aided DesignCAM Computer Aided ManufacturingCAE Computer Aided EngineeringPCB Printed Circuit Board 印刷电路板CAR Correction Action Report 改善报告NG Not Good 不良WDR Weekly Delivery Requirement 周出货要求PPM Percent Per Million 百万分之一TPM Total Production Maintenance 全面生产保养MRP Material Requirement Planning 物料需计划OS Operation System 作业系统TBA To Be Assured 待定,定缺D/C Drawing ChangeP/P Plans & ProcedureEMI Electrical-Music Industry 电子音乐工业Electrical Magnetic Interference 电子干扰RFI Read Frequency Input 读频输入MMC Maximum Material ConditionMMS Maximum Material SizeLMC Least Material ConditionLMS Least Material SizeLED lighting-emitting diode 发光二极管QBR Quarter Business RecordCIP Continuous improvement process FGI Forecasted Goal InventoryCNC Computerized numeral controllerB2C Business to customerB2B Business to businessAVL Approved vendor listPOP Procedure of packagingEOL End of lifeVDCS Vender defect correcting sheetPDCS Process defect correctingsheetGRN Goods receiving noteA/R Accounting receivableA/P Accounting payable通用类president董事长operator作业员position职务general manager总经理special assistant 特助deputy manager |'depjuti| =vice manager副理deputy supervisor =vice supervisor副课长group leader组长line leader线长supervisor 课长responsible department负责单位Human Resources Department人力资源部Head count 人头数production department生产部门planning department企划部QC Section品管课stamping factory冲压厂painting factory烤漆厂molding factory成型厂administration/general affairs dept./总务部production unit生产单位meeting minutes会议记录distribution department分发单位subject主题conclusion结论decision items决议事项pre-fixed finishing date预定完成日Color management 颜色管理Visual management目视管理production capacity生产力first count初盘first check初盘复櫂second count 复盘second check复盘复核quantity of physical inventory second count 复盘点数量physical inventory盘点数量physical count quantity帐面数量difference quantity差异量spare parts physical inventory list备品盘点清单cause analysis原因分析waste materials废料description品名specification 规格model机种work order工令revision版次remark备注registration登记registration card登记卡to control管制application form for purchase请购单consume, consumption消耗to notify通知to fill in填写to collect, to gather收集statistics统计cosmetic inspection standard外观检验规范computer case 电脑外壳(组件)personal computer enclosure电脑机箱产品front plate前板rear plate后板chassis |'∫si| 基座bezel panel面板Hood 上盖base pan基座bezel 面板riser card扩充卡flat cable排线TOP driver cage 上磁架bottom driver cage 下磁架resin film 树脂膜raw materials原料materials物料steel plate钢板roll/coil material卷料spare parts =buffer备品plastic parts塑胶件sheet metal parts/stamping parts 冲件material check list物料检查表finished product成品semi-finished product半成品good product/accepted goods/ accepted parts/good parts良品defective product/non-good parts不良品disposed goods处理品warehouse/hub仓库packing material包材basket蝴蝶竺plastic basket胶筐flow chart流程表单production tempo生产进度现状lots of production生产批量manufacture procedure制程to revise, modify修订to switch over to, switch—to, switching over切换engineering bottleneck, project difficulty工程瓶颈glove(s)手套glove(s) with exposed fingers割手套Band-Aid创可贴Industrial alcohol工业酒精broom扫把mop拖把vacuum cleaner吸尘器rag 抹布garbage container灰箕garbage can垃圾箱garbage bag垃圾袋liaison联络单rags抹布lamp holder灯架to mop the floor拖地to clean a table擦桌子air pipe 气管delivery deadline交货期die worker模工production, to produce生产equipment设备resistance电阻beacon警示灯coolant冷却液crusher破碎机club car高尔夫球车plate电镀power button电源按键reset button重置键forklift叉车Workshop traveler?天车trailer =long vehicle拖板车Hydraulic trolley手压车hydraulic hand jack油压板车casing = containerization装箱velocity速度patent专利coordinate座标supply and demand供求career card履历卡barricade隔板carton box纸箱to pull and stretch拉深work cell/work shop工作间sub-line支线bottleneck瓶颈模具工程类plain die简易模pierce die冲孔模forming die成型模progressive die连续模stage die工程模compound die复合模shearing die剪边模riveting die铆合模feature die公母模male die公模female die母模cavity型控母模core模心公模die change 换模to fix a die装模to repair a die修模punch set上模座punch pad上垫板punch holder上夹板stripper pad脱料背板up stripper上脱料板upper plate上模板lower plate下模板die pad下垫板die holder下夹板die set下模座bottom block下垫脚bottom plate下托板(底板)upper supporting blank上承板upper padding plate blank上垫板top plate上托板（顶板）top block上垫脚stripping plate内外打(脱料板)outer stripper外脱料板inner stripper内脱料板lower stripper下脱料板punch冲头insert入块(嵌入件)deburring punch压毛边冲子groove punch压线冲子stamped punch字模冲子round punch圆冲子special shape punch异形冲子bending block折刀roller滚轴baffle plate挡块located block定位块supporting block for location定位支承块air cushion plate气垫板air-cushion eject-rod气垫顶杆trimming punch切边冲子stiffening rib punch = stinger 加强筋冲子ribbon punch压筋冲子reel-stretch punch卷圆压平冲子guide plate定位板sliding block滑块sliding dowel block滑块固定块die locker锁模器pressure plate =plate pinch压板thickness gauge厚薄规cutting die, blanking die冲裁模die block模块folded block折弯块sliding block滑块location pin定位销lifting pin顶料销die plate, front board模板padding block垫块stepping bar垫条panel board镶块to load a die装上模具to unload a die?御模具active plate活动板lower sliding plate下滑块板upper holder block上压块upper mid plate上中间板spring box弹簧箱spring-box eject-rod弹簧箱顶杆spring-box eject-plate弹簧箱顶板bushing block衬套cover plate盖板guide pad导料块pilot导正筒trim剪外边pierce剪内边pocket for the punch head挂钩槽slug hole废料孔radius半径shim/wedge/heel/pad/spacer/gasket楔子torch-flame cut火焰切割set screw止付螺丝form block折刀round pierce punch =die button圆冲子shape punch =die insert异形子stock located block定位块metal plate钣金miller铣床grinder磨床tolerance公差score =groove压线sliding block滑块lathe车active plate活动板baffle plate挡块cover plate盖板groove punch压线冲子air-cushion eject-rod气垫顶杆spring-box eject-plate弹簧箱顶板capability能力parameter参数factor系数driller钻床set up die架模height of die setting up架模高度analog-mode device类模器inner guiding post内导柱inner hexagon screw内六角螺钉dowel pin固定销coil spring弹簧lifter pin顶料销eq-height sleeves =spool等高套筒pin销lifter guide pin浮升导料销guide pin导正销wire spring圆线弹簧outer guiding post外导柱stop screw止付螺丝located pin定位销outer bush外导套press specification冲床规格die height闭模高度flow mark流痕welding mark溶合痕post screw insert螺纹套筒埋值self tapping screw自攻螺丝stripper plate脱料板piston活塞handle mold手持式模具flash mold溢流式模具positive mold挤压式模具split mold分割式模具die lifter举模器top stop上死点bottom stop下死点one stroke一行程to continue, cont.连动to grip(material)吸料location lump, locating piece, location block定位块reset复位to file burr 锉毛刺embedded lump |in'bed| |lùmp|镶块stamping-missing漏冲to tight a bolt拧紧螺栓to loosen a bolt拧松螺栓punched hole冲孔to cut edge =side cut =side scrap 切边to bending折弯to pull, to stretch拉伸engraving, to engrave刻印stamping 油印to stake铆合designing, to design设计design modification 设计修改成gauge(or jig)治具pedal踩踏板stopper阻挡器flow board流水板torque扭矩spline =the multiple keys花键quenching淬火tempering回火annealing退火carbonization碳化alloy合金tungsten high speed steel钨高速的moly high speed steel钼高速的forming成型(抽凸,冲凸)draw hole抽孔bending折弯emboss凸点dome凸圆semi-shearing半剪stamp mark冲记号deburr or coin压毛边punch riveting冲压铆合side stretch侧冲压平reel stretch卷圆压平groove压线stamp letter冲字(料号)tick-mark nearside正面压印tick-mark farside反面压印extension DWG展开图procedure DWG工程图die structure DWG模具结构图冲压类punch,press冲punching machine 冲床hydraulic machine油压机jack升降机decoiler整平机manufacture management制造管理stamping, press冲压feeder送料机rack, shelf, stack料架taker取料机to reverse material 翻料to load material上料to unload material卸料to return material/stock to退料scraped |'skr?pid|报废scrape ..v.刮;削robot机械手production line流水线packaging tool打包机packaging打包成型类well type蓄料井insulated runner绝缘浇道方式hot runner热浇道runner plat浇道模块valve gate阀门浇口band heater环带状的电热器spindle阀针spear head刨尖头slag well冷料井cold slag冷料渣air vent排气道welding line熔合痕eject pin顶出针knock pin顶出销return pin回位销反顶针sleeve套筒stripper plate脱料板insert core放置入子runner stripper plate浇道脱料板guide pin导销eject rod (bar)（成型机）顶业捧subzero深冷处理three plate三极式模具runner system浇道系统stress crack应力电裂orientation定向sprue gate射料浇口，直浇口nozzle射嘴sprue lock pin料头钩销(拉料杆) slag well冷料井side gate侧浇口edge gate侧缘浇口tab gate搭接浇口film gate薄膜浇口flash gate闸门浇口slit gate缝隙浇口fan gate扇形浇口dish gate因盘形浇口diaphragm gate隔膜浇口ring gate环形浇口submarine gate潜入式浇口tunnel gate隧道式浇口pin gate针点浇口runner less无浇道sprue less无射料管方式long nozzle延长喷嘴方式spur浇口;溶waste废料board看板sliding rack滑料架to impose lines压线to compress, compressing压缩character die字模to feed, feeding送料material change, stock change材料变更feature change 特性变更prepare for, make preparations for 准备rotating speed, revolution转速abnormal handling异常处理Assembly line组装线Layout布置图Conveyer流水线运输带Rivet machine拉钉机Rivet gun拉钉枪Screw driver起子Electric screw driver电动起子Hydraulic machine 液压机Pneumatic screw driver气动起子automation自动化to stake, staking, riveting铆合add lubricant oil加润滑油argon welding氩焊cylinder油缸robot机械手conveying belt输送带transmission rack输送架to draw holes抽孔bolt螺栓nut 螺母screw 螺丝identification tag标示单screwdriver plug起子插座automatic screwdriver电动启子to move, to carry, to handle搬运be put in storage入库packing包装staker = riveting machine铆合机fit together组装在一起fasten锁紧(螺丝)fixture 夹具(治具)pallet/skid栈板barcode条码barcode scanner条码扫描器fuse together熔合fuse machine/heat stake热熔机processing, to process加工delivery, to deliver 交货to return delivery to. to send delivery back to return of goods 退货easily damaged parts易损件standard parts标准件to lubricate润滑spring 弹簧spare tools location/buffer手工备品仓spare molds location模具备品仓tox machine自铆机烤漆类phosphate皮膜化成viscosity涂料粘度alkalidipping脱脂main manifold主集流脉organic solvent有机溶剂demagnetization去磁;消磁high-speed transmission高速传递heat dissipation热传rack上料volatile挥发性degrease脱脂rinse水洗alkaline etch龄咬desmot剥黑膜D.I. rinse纯水次Chromate铬酸处理Anodize阳性处理seal封孔scraped products报放品disposed products处理品dismantle the die折模auxiliary function辅助功能heater band 加热片thermocouple热电偶derusting machine除锈机degate打浇口dryer烘干机induction感应induction light感应光response =reaction =interaction感应ram连杆edge finder巡边器concave凸convex凹cold slug冷块blush 导色gouge沟槽;凿槽satin texture段面咬花witness line证示线grit沙砾granule =pellet =grain细粒sand blasting喷沙grit maker抽粒机cushion缓冲fillet镶;嵌边roller pin formality滚针形式cam driver铡楔shank摸柄crank shaft曲柄轴品质类qualified products, up-to-grade products良品defective products, not up-to-grade products不良品defective product box不良品箱poor processing 制程不良poor incoming part来件不良exposed metal/bare metal金属裸露excessive defect过多的缺陷critical defect极严重缺陷major defect主要缺陷minor defect次要缺陷not up to standard不合规格cosmetic defect外观不良lack of painting烤漆不到位slipped screw head/slippery slipped thread滑丝missing part漏件wrong part错件oxidation氧化defective threading抽芽不良poor staking铆合不良deficient purchase来料不良deficient manufacturing procedure制程不良cosmetic inspection外观检查inner parts inspection内部检查blister 气泡angular offset 角度偏差dent 压痕scratch 刮伤deformation 变形filings 铁削defective label 不良标签abrasion 磨损Breaking. (be)broken,(be)cracked 断裂short射料不足nick缺口speck瑕疪shine亮班splay 银纹gas mark焦痕delaminating起鳞speckle斑点mildewed =moldy = mouldy发霉deformation变形burr(金属)flash(塑件)毛边poor staking铆合不良excessive gap间隙过大grease/oil stains油污inclusion杂质shrinking/shrinkage缩水mixed color杂色fold of packaging belt打包带折皱painting make-up补漆discoloration羿色water spots水渍impurity 杂质Mismatch 错位failure, trouble故障deformation 变形rust 生锈peel 脱漆Shrink缩水Contamination 脏污water spots 水渍Gap 间隙label error 标签错误Missing label 漏贴rejection criteria拒收标准Suspected rejects 可疑庇abrasion 损伤、磨损Texture surface 印花纹表面Streak 条纹stains 污点Blotch 斑点discoloration 脱色Inclusion 杂质slug mark 压痕dirt grime 灰尘blush 毛边薄膜sink 下凹Hickey 漏漆labels and logos贴纸与商标Configuration labels?组合贴纸corrugated container?瓦摆纸箱Delaminating 脱层splattering 散点Gouge锉孔puckering 折痕。
美国应对细菌耐药国家行动计划
NAT IONA L AC T ION PL A N FOR COM BAT I NG A N T IBIOT IC-R ESISTA N TBAC TER I AM A R C H2015Table of ContentsExecutive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Goals1 .Slow the Emergence of Resistant Bacteria and Prevent the Spread of ResistantInfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .112 .Strengthen National One-Health Surveillance Efforts to Combat Resistance . . . . .243 .Advance Development and Use of Rapid and Innovative Diagnostic Tests forIdentification and Characterization of Resistant Bacteria . . . . . . . . . . . . .364 .Accelerate Basic and Applied Research and Development for New Antibiotics,Other Therapeutics, and Vaccines . . . . . . . . . . . . . . . . . . . . . .405 .Improve International Collaboration and Capacities for Antibiotic-resistancePrevention, Surveillance, Control, and Antibiotic Research and Development . . . . .49 Tables1 .National Targets for Combating Antibiotic-Resistant Bacteria . . . . . . . . . . .62 .Goals and Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . .93 .Antibiotic-Resistant Threats in the United States . . . . . . . . . . . . . . . .60 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60Executive SummaryAntibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world . Today, however, the emergence of drug resistance in bacteria is reversing the miracles of the past eighty years, with drug choices for the treatment of many bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent . The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause two million illnesses and approximately 23,000 deaths each year in the United States alone .The National Action Plan for Combating Antibiotic-resistant Bacteria provides a roadmap to guide the Nation in rising to this challenge . Developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria—issued by President Barack Obama on September 18, 2014—the National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology (PCAST) . Although its primary purpose is to guide activities by the U .S .Government, the National Action Plan is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug-resistant threats that affect people in the U .S .and around the world . Implementation of the National Action Plan will also support World Health Assembly resolution 67 .25 (Antimicrobial Resistance), which urges countries to take urgent action at the national, regional, and local levels to combat resistance .The goals of the National Action Plan include:1. Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections .2. Strengthen National One-Health Surveillance Efforts to Combat Resistance .3. Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification andCharacterization of Resistant Bacteria .4. Accelerate Basic and Applied Research and Development for New Antibiotics, OtherTherapeutics, and Vaccines .5. Improve International Collaboration and Capacities for Antibiotic-resistance Prevention,Surveillance, Control, and Antibiotic Research and Development .By 2020, implementation of the National Action Plan will lead to major reductions in the incidence of urgent and serious threats, including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile (see Table 1) . The National Action Plan will also result in improved antibiotic stewardship in healthcare settings, prevention of the spread of drug-resistant threats, elimination of the use of medically-important antibiotics for growth promotion in food animals, and expanded surveillance for drug-resistant bacteria in humans and animals .Other significant outcomes include creation of a regional public health laboratory network, establishment of a specimen repository and sequence database that can be accessed by industrial and academic research-ers, development of new diagnostic tests through a national challenge, and development of two or moreNAT I ONAL ACT I ON P LAN FOR COMBAT I NG ANT I BI OT I C-RESISTANT BACT ERIA antibiotic drug candidates or non-traditional therapeutics for treatment of human disease . In addition, the effort to combat resistant bacteria will become an international priority for global health security . Progress towards achieving these outcomes will be monitored by the U .S .Government Task Force that developed the National Action Plan. The Task Force, which is co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services, includes representatives from the Departments of State, Justice, Veterans Affairs, and Homeland Security, as well as the Environmental Protection Agency, the United States Agency for International Development, the Office of Management and Budget, the Domestic Policy Council, the National Security Council, the Office of Science and Technology Policy, and the National Science Foundation . Additionally, the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, created by Executive Order 13676, will provide advice, information, and recommendations to the Secretary of Health and Human Services regarding the National Action Plan’s programs and policies and their impact on the threat .Implementation of the objectives and activities in the National Action Plan requires sustained, coordi-nated, and complementary efforts of individuals and groups around the world, including healthcare providers, healthcare leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients . All of us who depend on antibiotics must join in a common effort to detect, stop, and prevent the emergence and spread of resistant bacteria .IntroductionVision: The United States will work domestically and internationally to prevent, detect, and control illness and death related to infections caused by antibiotic-resistant bacteria byimplementing measures to mitigate the emergence and spread of antibiotic-resistance and ensuring the continued availability of therapeutics for the treatment of bacterial infections. Antibiotics have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world . Today, however, the emergence of drug resistance in bacteria is reversing the gains of the past eighty years, with many important drug choices for the treatment of bacterial infections becoming increasingly limited, expensive, and, in some cases, nonexistent . The Centers for Disease Control and Prevention (CDC) estimates that each year at least two million illnesses and 23,000 deaths are caused by drug-resistant bacteria in the United States alone .The loss of antibiotics that kill or inhibit the growth of bacteria means that we can no longer take for granted quick and reliable treatment of rare or common bacterial infections, including bacterial pneu-monias, foodborne illnesses, and healthcare-associated infections . As more strains of bacteria become resistant to an ever larger number of antibiotics, we will also lose the benefits of a range of modern medi-cal procedures—from hip replacements to organ transplants—whose safety depends on our ability to treat bacterial infections that may arise as post-surgical complications . Moreover, antibiotic-resistance also threatens animal health, agriculture, and the economy .The National Action Plan for Combating Antibiotic-resistant Bacteria provides a roadmap to guide the Nation in rising to this challenge . The National Action Plan outlines steps for implementing the National Strategy for Combating Antibiotic-Resistant Bacteria and addressing the policy recommendations of the President’s Council of Advisors on Science and Technology . Although its primary purpose is to guide activities by the U .S .Government, the National Action Plan is also designed to guide action by public health, healthcare, and veterinary partners in a common effort to address urgent and serious drug-resistant threats (Table 3) that affect people in the U .S .and around the world .Goals of the National Action PlanThe National Action Plan—informed by the guiding principles in Table 2—is organized around five goals for collaborative action by the U .S .Government, in partnership with foreign governments, individuals, and organizations aiming to strengthen healthcare, public health, veterinary medicine, agriculture, food safety, and research and manufacturing . Aggressive action will move the nation towards major reductions in the incidence of urgent and serious drug-resistant threats (Table 3), including carbapenem-resistant Enterobacteriaceae (CRE), methicillin-resistant Staphylococcus aureus (MRSA), and Clostridium difficile.•Misuse and over-use of antibiotics in healthcare and food production continue to hasten the development of bacterial drug resistance, leading to loss of efficacy of existing antibiotics .•Detecting and controlling antibiotic-resistance requires the adoption of a “One-Health” approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment .•Implementation of evidence-based infection control practices can prevent the spread of resistant pathogens .•Interventions are necessary to accelerate private sector investment in the development of therapeutics to treat bacterial infections because current private sector interest in antibiotic development is limited .•Researchers can use innovations and new technologies—including whole genome sequencing, metagenomics, and bioinformatic approaches—to develop next-generation tools to strengthen human and animal health, including:−Point-of-need diagnostic tests to distinguish rapidly between bacterial and viral infections as well as identify bacterial drug susceptibilities;−New antibiotics and other therapies that provide much needed treatment options for those infected with resistant bacterial strains; and−Antibiotic resistance is a global health problem that requires international attention and collaboration, because bacteria do not recognize borders .1. The TB activities identified in the NAP are included as they represent critical near-term public health activities that will support progress to reduce the burden of drug-resistant TB in the U .S . Additional domestic and global activitiesto address drug-resistant TB will be provided in a companion action plan specific to TB and will be submitted to the President no later than September, 2015 . The companion action plan will build on recommendations of the Federal TB Task Force (http://www .cdc .gov/mmwr/pdf/rr/rr5803 .pdf) as well the work of the interagency USG TB working group . Those goals include:GOAL 1: Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant Infections. Judicious use of antibiotics in healthcare and agricultural settings is essentialto slow the emergence of resistance and extend the useful lifetime of effective antibiotics .Antibiotics are a precious resource, and preserving their usefulness will require cooperationand engagement by healthcare providers, healthcare leaders, pharmaceutical companies,veterinarians, the agricultural industry, and patients . Goal 1 activities include the optimaluse of vaccines to prevent infections, implementation of healthcare policies and antibioticstewardship programs that improve patient outcomes, and efforts to minimize the develop-ment of resistance by ensuring that each patient receives the right antibiotic at the right timeat the right dose for the right duration. Prevention of resistance also requires rapid detectionand control of outbreaks and regional efforts to control transmission across community andhealthcare settings .GOAL 2: Strengthen National One-Health Surveillance Efforts to Combat Resistance. Improved detection and control of drug-resistant organisms will be achieved through an integrated,“One-Health” approach that includes the enhancement and integration of data from surveil-lance systems that monitor human pathogens—including the National Healthcare SafetyNetwork (NHSN), the Emerging Infections Program (EIP), and the National AntimicrobialResistance Monitoring System (NARMS)—with data from surveillance systems that monitoranimal pathogens—including the National Animal Health Monitoring System (NAHMS),the National Animal Health Laboratory Network (NAHLN), and the Veterinary LaboratoryInvestigation and Response Network (Vet-LIRN) . Goal 2 activities include creation of aregional public health laboratory network that provides a standardized platform for resistancetesting and advanced capacity for genetic characterization of bacteria (e .g ., through wholegenome sequencing) . Goal 2 activities will also enhance monitoring of antibiotic sales, usage,resistance, and management practices at multiple points along in the food-production chain,from farms to processing plants to supermarkets .GOAL 3: Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria. Improved diagnostics fordetection of resistant bacteria and characterization of resistance patterns will help healthcareproviders make optimal treatment decisions and assist public health officials in taking actionto prevent and control disease . Improved diagnostics will also help decrease unnecessaryor inappropriate use of antibiotics . Goal 3 activities will accelerate the development of newdiagnostics and expand their availability and use to improve treatment, enhance infectioncontrol, and achieve faster response to infections and outbreaks caused by resistant bacteriain hospitals and in the community .GOAL 4: Accelerate Basic and Applied Research and Development for New Antibiotics, Other Therapeutics, and Vaccines. Despite the urgent need for new antibiotics, the number ofproducts in the drug-development pipeline is small and commercial interest remains limited .The advancement of drug development—as well as non-traditional therapeutics and vac-cines—will require intensified efforts to boost scientific research, attract private investment,and facilitate clinical trials of new drug candidates . Goal 4 activities will help accomplish theseobjectives by supporting basic and applied research, providing researchers with scientificservices (e .g ., specimens, sequence data, and regulatory guidance), and fostering public-private partnerships that strengthen the clinical trials infrastructure and reduce the risks,uncertainty, and obstacles faced by companies who are developing new antibiotics and/orother therapeutics and vaccines that can impact the use of antibiotics and the developmentof resistance .GOAL 5: Improve International Collaboration and Capacities for Antibiotic-resistance Prevention, Surveillance, Control, and Antibiotic Research and Development. Antibioticresistance is a worldwide problem that cannot be addressed by one nation in isolation . Goal5 activities include working with foreign ministries of health and agriculture, the World HealthOrganization (WHO), the Food and Agriculture Organization (FAO), the World Organizationfor Animal Health (OIE), and other multinational organizations to enhance global capacity todetect, analyze, and report antibiotic use and resistance, create incentives for the develop-ment of therapeutics and diagnostics, and strengthen global efforts to prevent and controlthe emergence and spread of antibiotic-resistance . To advance these objectives, U .S .agencieswill support development of a WHO Global Action Plan on Antimicrobial Resistance, enhanceinternational collaborations including cooperation under the European Union-United StatesTrans-Atlantic Task Force on Antimicrobial Resistance (TATFAR), and mobilize global healthresources through the Global Health Security Agenda .Development of the National Action PlanThe National Action Plan was developed in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria (Appendix 2), which was issued by President Barack Obama on September 18, 2014 in conjunction with the National Strategy for Combating Antibiotic-Resistant Bacteria.The Executive Order calls for a U .S .Government Task Force to create a five-year action plan that lays out steps and milestones for achieving the Strategy’s goals and objectives (Table 2) and addressing the PCAST recommendations . The Task Force, which is co-chaired by the Secretaries of Defense, Agriculture, and Health and Human Services, includes representatives from the Department of State, the Department of Justice, the Department of Veterans Affairs, the Department of Homeland Security, the Environmental Protection Agency, the United States Agency for International Development, the Office of Management and Budget, the Domestic Policy Council, the National Security Council staff, the Office of Science and Technology Policy, and the National Science Foundation .Development of the National Action Plan also supports World Health Assembly (WHA) resolution 67 .25 (Antimicrobial Resistance), which was endorsed in May 2014 and urges countries to develop and finance national plans and strategies and take urgent action at the national, regional, and local levels to combat resistance . The resolution urges WHA Member States to develop practical and feasible approaches to, among other actions, extend the lifespan of drugs, strengthen pharmaceutical management systems and laboratory infrastructure, develop effective surveillance systems, and encourage the development of new diagnostics, drugs, and treatment options .These recommendations are intended to inform the policy development process, and are not intended as a budget document . The commitment of resources to support these activities will be determined through the usual Executive Branch budget processes . Implementation of some of the actions in this report will require additional resources and these resources could be new or redirected from lower-priority Agency activities .Monitoring and EvaluationThe Task Force created under Executive Order 13676 is charged with providing the President with annual updates on Federal Government actions to combat antibiotic resistance, including progress made in implementing the National Action Plan, plans for addressing obstacles and challenges, and recommenda-tions for new or modified actions . The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria will provide advice, information, and recommendations to the Secretary of Health and Human Services regarding the programs and policies developed in the National Action Plan .Partnerships and ImplementationImplementation of the National Action Plan will require the sustained, coordinated, and complemen-tary efforts of individuals and groups around the world, including public and private sector partners, healthcare providers, healthcare leaders, veterinarians, agriculture industry leaders, manufacturers, policymakers, and patients . All of us who depend on antibiotics must join in a common effort to detect, stop, and prevent the emergence and spread of resistant bacteria .NAT I ONAL ACT I ON P LAN FOR COMBAT I NG ANT I BI OT I C-RESISTANT BACT ERIAGOAL 1. Slow the Emergence of Resistant Bacteria and Prevent the Spread of Resistant InfectionsJudicious use of antibiotics in healthcare and agricultural settings is essential to slow the emergence of resistance and extend the useful lifetime of effective antibiotics . Antibiotics are a precious resource, and preserving their usefulness will require cooperation and engagement by healthcare providers, healthcare leaders, pharmaceutical companies, veterinarians, the agricultural industry, and patients . Effective dissemination of information to the public is critical . Prevention of resistance also requires rapid detection and control of infections and outbreaks (see also Goal 2) and regional efforts to control transmission across community and healthcare settings .Goal 1 includes activities to foster antibiotic stewardship by improving prescribing practices across all healthcare settings, prevent the spread of drug-resistant threats in healthcare facilities and communities, and reduce and eventually eliminate the use of medically-important antibiotics for growth promotion in animals .By 2020, significant outcomes of Goal 1 will include:•Establishment of antibiotic stewardship programs in all acute care hospitals and improved antibiotic stewardship across all healthcare settings .•Reduction of inappropriate antibiotic use by 50% in outpatient settings and by 20% in inpatient settings .•Establishment of State Antibiotic Resistance (AR) Prevention (Protect) Programs in all 50 states to monitor regionally important multidrug resistant organisms and provide feedback and technical assistance to healthcare facilities .Actions taken to achieve Goal 1 will fulfill:• Executive Order 13676, Sections 5 and 7:−Improved Antibiotic Stewardship−Preventing and Responding to Infections and Outbreaks with Antibiotic-Resistant Organisms• Provisions in PCAST Recommendations #2, #6, and #7:−Effective Surveillance & Response for Antibiotic-resistance−Improving Stewardship of Existing Antibiotics in Health Care−Limit the Use of Antibiotics in Animal Agriculture•Elimination of the use of medically-important antibiotics for growth promotion in food-pro-ducing animals .•Requirement of veterinary oversight for use of medically-important antibiotics in the feed or water of food-producing animals .1.1 Implement public health programs and reporting policies that advanceantibiotic resistance prevention and foster antibiotic stewardship inhealthcare settings and the community.Perhaps the single most important action to slow the development and spread of antibiotic-resistant infections is to change the way antibiotics are used . Antibiotics are overprescribed in both human and animal settings, which makes everyone less safe . Investments in this area will be used to develop education and outreach programs to clarify and strengthen responsible, appropriate use of antibiotics in humans and animals . Efforts in this area will help greatly in slowing down the spread of resistant bacteria . This commitment to always use antibiotics appropriately and safely—to use the right antibiotic at the right time at the right dose for the right duration—is known as antibiotic stewardship.Sub-Objective 1.1.1A: Strengthen antibiotic stewardship in inpatient, outpatient, and long-term care settings by expanding existing programs, developing new ones, and monitoring progress and efficacy .The establishment and expansion of antibiotic stewardship programs will improve patient outcomes and minimize the development of resistance by ensuring judicious use of antibiotics .Milestones for provision of educational materials to enhance antibiotic stewardship in outpatient settings are provided under Sub-Objective 1 .1 .1B .MilestonesWithin one year:•The Departments of Health and Human Services (HHS), Defense (DOD), and Veterans Affairs (VA) will review existing regulations and propose new ones, as needed, requiring hospitals, ambulatory surgery centers, dialysis facilities, and other inpatient facilities to implement robust antibiotic stewardship programs that align with the CDC Core Elements. HHS, DOD, and VA will also work together to optimize standardization of stewardship programs and activities, including monitoring activities and reporting criteria .•The National Healthcare Safety Network (NHSN) will begin tracking the number of healthcare facilities with stewardship policies and programs in place .•DOD will establish a multidisciplinary group, under the purview of the Assistant Secretary of Defense for Health Affairs, to support and coordinate stewardship activities across DOD .Within three years:•All hospitals that participate in Medicare and Medicaid programs must comply with Conditions of Participation (COP) . The Centers for Medicare & Medicaid Services (CMS) will issue new COPs or revise current COP Interpretive Guidelines to advance compliance with recommendations in CDC’s Core Elements of Hospital Antibiotic Stewardship Programs. HHS, DOD, and VA will also implement policies that:−Encourage implementation of antibiotic stewardship programs as a condition for receiving Federal grants for health care delivery (e .g ., in community healthcare centers) .−Require health facilities operated by the U .S . Government to develop and implement antibiotic stewardship programs and participate in NHSN reporting (see Objective 2 .2) .•All acute care hospitals governed by the CMS COP will implement antibiotic stewardship pro-grams . CMS will expand COP requirements to apply to long-term acute care hospitals, other post-acute facilities, ambulatory surgery centers, and dialysis centers .•CMS will revise existing Interpretive Guidelines (IGs), as needed, to include antimicrobial steward-ship improvements . For example, IGs on Quality Assurance and Performance Improvement for hospitals may incorporate antibiotic-stewardship performance measures developed by the CDC, the Agency for Healthcare Research and Quality (AHRQ), or other professional organizations .•Training webinars for CMS surveyors will be updated to include information on antibiotic utilization in nursing homes, in accordance with existing IGs in the Infection Control Nursing Home regulations .•CDC, CMS, AHRQ, and other partners will issue guidance on antibiotic stewardship and best practices for ambulatory surgery centers, dialysis centers, nursing homes and other long-term care facilities, doctors’ offices and other outpatient settings, pharmacies, emergency depart-ments, and medical departments at correctional facilities .•At least 25 States, the District of Columbia, and Puerto Rico will establish or enhance antibiotic stewardship activities in inpatient healthcare delivery settings, in accordance with the CDC Core Elements . CDC will support these efforts via State AR Prevention (Protect) Programs for Healthcare (“AR Protect Programs”; see also Sub-Objective 1 .1 .2) .Within five years:•DOD will support antibiotic stewardship programs and interventions critical for maintaining quality health care throughout the Military Healthcare System (MHS) .•CDC will work with select hospital systems to expand antibiotic use reporting and steward-ship implementation, and will partner with nursing organizations to develop and implement stewardship programs and interventions in a set of nursing homes .•All states will establish or enhance antibiotic stewardship activities in healthcare delivery settings .Sub-Objective 1.1.1B: Strengthen educational programs that inform physicians, veterinari-ans, members of the agricultural industry, and the public about good antibiotic stewardship .Educational programs that promote good antibiotic stewardship in healthcare settings include:•Get Smart: Know When Antibiotics Work . Many antibiotics prescribed in doctors’ offices, clinics, and other outpatient settings are not needed . This program focuses on appropriate antibiotic prescribing and use for common illnesses in children and adults .•Get Smart for Healthcare. Many patients in hospitals, nursing homes, and other healthcare facili-ties receive antibiotics to fight infections, but these drugs are often prescribed incorrectly . This program helps clinicians prescribe the right drugs for the right patients at the right doses and times . The United States Department of Agriculture (USDA), CDC, and the Food and Drug Administration (FDA) will also continue to work with partners in the agriculture industry to advance appropriate use of antibiotics in food animals and promote collaborations among partners in medicine, veterinary medicine, and public health .Additional milestones for provision of educational materials to enhance antibiotic stewardship in agri-cultural settings are provided under Sub-Objectives 1 .2 .3 and 1 .3 .1 .MilestonesWithin one year:•CDC and VA will apply lessons learned from the CDC and VA pilot project to provide clinicians with support for making prescribing decisions based on judicious use of antibiotics and will submit a manuscript for publication describing initial research findings from this effort . Within three years:•CDC will support public health departments in establishing statewide programs for antibiotic stewardship and appropriate antibiotic use . These programs will identify healthcare facilities with high antibiotic-prescribing rates and use lessons learned from the CDC and VA pilot project (see above) and other best practices to improve antibiotic prescribing in these facilities . The success of these efforts will be assessed by measuring changes in prescribing rates and in clini-cians’ understanding of antibiotic stewardship activities and programs .•CDC will provide technical assistance to Federal facilities (e .g ., those operated by DOD, the VA, and the Indian Health Service) and other large health systems in scaling up implementation and assessment of interventions to improve outpatient antibiotic prescribing, extending effective interventions to long-term care settings, and ensuring long-term sustainability of antibiotic stewardship efforts .•DOD will initiate the planning and approval process to modify clinical decision-support interven-tions in DOD facilities in targeted regions .•CDC, CMS, and partners will propose expanded quality measures for antibiotic prescribing .。
FortiTester 网络安全测试工具说明说明书
Data SheetFortiTesterFortiTester is a network security testing tool designed to identify and evaluate network security devices and applications. It can simulate network traffic, including malicious traffic, and test how security devices perform in detecting and mitigating threats. FortiTester supports a wide range of traffic types, including SSL, DDoS, and custom traffic.It is an easy-to-use tool that allows security teams to assess the effectiveness of theirnetwork security solutions before deploying them in production environments. With FortiTester, organizations can ensure that their security infrastructure is capable of defending against advanced threats and is optimized for maximum performance.Performance Testing and Breach Attack Simulation Highlightsn Up-to-date cyberthreat simulation based on real world insightn Best price andperformance trafficgeneration and security testing systemn Flexible operationmodes from one standalonedevice up to 8 devices combinedn Hardware, virtualappliances, and public cloudn Server-Class hardwareand packet-processing enhancementsn Throughput Testingup to 80 Gbps/800 Gbps Bi-directionalThroughputn Easy and Simple Web UIAvailable inCloudHostedVirtualApplianceFeaturesPerformance Testing and Traffic GenerationHTTP, HTTPS, HTTP/2, UDP Throughput, RFC2544, SSLVPN for FortiGates, and IPSEC testing, Traffic enterprise mix generation, and Q-in-Q traffic generation.Breach Attack SimulationMITRE ATT&CK simulation testing, CVE-based IPS testing, Fuzzing testing, Web/IOT attacks, FortiGuard Malware strike pack (with 20+ Ransomware), DDoS traffic generation, and PCAP replay.Comprehensive APIAutomate testing and simulation with full system, test simulation, and reporting API.HighlightsTraffic Generation and Performance Testing •HTTP, HTTPS, and HTTP/2 •UDP (PPS/Payload)•TCP (Throughput, TurboTCP, CPS) •RFC 2544 / RFC 3511 •SSLVPN and IPSEC testing (CPS/RPS/CC/Throughput) •PCAP Replay, GTP Replay •Q-in-Q Traffic Generation•Scheduled Testing (hourly, daily, monthly)Traffic Mix•Enterprise Mix, IMix, Fortinet Enterprise, Enterprise Lite, Custom Protocol Support•TCP (CIFS, SMBv2, FIX, FTP, IMAP, LDAP, NFS, POP3, RDP, SMTP, SSH), UDP, DHCP, ICMP, RTSP/RTP, DNS (including DNS-AXFR)Applications•Amazon S3, AOL Chat, BitTorrent, DB2, Facebook, Gmail, GTalk, MSSQL, MySQL, NetFlix, Oracle TNS, PSQL, Twitter, WebEx, WhatsApp, Yahoo Mail, YouTube Flexible Form Factor•Powerful Appliances with 1G/10G/40G/100G Output•Up to 80 Gbps and 800 Gbps Bi-Directional Traffic Simulation•VM Form Factor supporting ESXi, KVM, OpenStack•Public Cloud Support*: AWS, Azure, Alibaba, GCP, OCI, IBM Cloud•Test Centre Mode - up to eight devices in cluster (see model compatibility)* BYOL support for public cloud, contact SE if images are not available on market place.Breach Attack Simulation•MITRE ATT&CK® Adversary Simulation •Pre and Post Breach Simulation •Comprehensive Reporting Comprehensive Reporting •PDF Exports•API Retrieval of Cases Result and Reports Security Testing•DDoS testing (HTTP/UDP/TCP Session Flood)•TCP / UDP / ICMP / IP Fuzzing Attack •IPS Attacks (CVE-based and HTTP Evasion, SCADA/IOT attacks, Buffer Overflow, Code Injection, Path Traversal)•Malware Strike Pack (Updated by FortiGuard daily with categories such as Ransomware and Trojan)•Web Attacks (Cross Site scripting, SQL injection, Bad Robots, Privilege Escalation) •Web Crawler (bulk URL replay)Extensive API Support •Case Management •System Management •Object Management •User Management•MITRE ATT&CK Management Third Party Integration•Administrator and RADIUS Support •SYSLOG•SNMP Traps and MIBs Support •Certification Management•FortiOS v7.0.1+ (Security Fabric Integration) •FortiManager v6.4.6 and 7.0.1 (License activation and FortiGuard server updates) •FortiSIEM v5.3.0 log integrationDEPLOYMENTStandalone ModeTest center works with the local traffic generator and receiver.Test Centre ModeScale FortiTester performance by combining up to eight FortiTesters in a cluster.Public Cloud SupportScale FortiTester performance by combining up to eight FortiTesters in a cluster.Use CasesSecure Infrastructure Validation•Evaluate Advanced Threat Protection (ATP) Technology •Validate Technology, People, and ProcessBreach Attack Simulation•MITRE ATT&CK® Simulation•Pre/Post Breach SimulationVendor Bake-Off•Datasheet Performance Evaluation•Future ProofingPublic Cloud Testing•AWS, Azure, GCP, OCI, IBM, Alibaba •Architecture Validation•Load Testing in MarketplacesSPECIFICATIONSHTTP Connections Per Second 700 000 5 600 000961 0007 200 000HTTP Concurrent Connections 9 000 00072 000 0009 000 00072 000 000SSL Throughput9.9 Gbps 79.6 Gbps 15 Gbps 118.4 Gbps SSL Connections Per Second 250010 00018 00084 000SSL Concurrent Connections 80 000640 00080 000640 000IPsec Yes Yes Yes Yes SSL-VPNYes Yes Yes Yes Protocol TCP (CIFS, SMB, FIX,FTP, IMAP, LDAP, NFS, POP3, RDP, SMTP, SSH), UDP, DHCP, ICMP, RTSP/RTPYesYesYesYesRFC2544 and 3511Yes Yes Yes Yes IPS, Malware, MITRE ATT&CK, FUZZING, and DDOSYes Yes Yes Yes Replay — PCAP, Traffic, Attack, GTPYes Yes Yes Yes Traffic Mix (Enterprise / Lite / Fortinet Mix)YesYesYesYesSafetyU/cUL, CB, BSMIUL/cUL, CB , BSMIFortiTester 2000F/2500E – Based on SSL/TLS cipher suite: AES256-GCM-SHA384 with 2K key size.SPECIFICATIONSHeight x Width x Length (mm)44 x 438 x 58044 x 437 x 610 Weight22.6 lbs (10.3 kg)24.1 lbs (10.95 kg) Power Required100–240V AC, 63-47 Hz, Redundant100–240V AC, 50-60 Hz, Redundant300 W / 360 WPower Consumption(Average / Maximum)Maximum Current120V/5A, 240V/3A100V/2.3A, 240V/0.94A Heat Dissipation1160 BTU/h767 BTU/h Redundant Power Supplies Dual Power Supplies Dual Power SuppliesSafety CSA, C/US, CE, ULSPECIFICATIONSVirtual MachineHypervisor Support VMware ESX/ESXi, KVM, AWS, Azure, GCP, OCI, IBM, AlibabavCPUs2481632 Memory 6 GB10 GB18 GB34 GB44 GB Storage60 GBNetwork Interfaces 1 Management (E1000) + 4 Tester (PCI passthrough Intel(R) Ethernet Network Adapter x710HTTP Throughput (Gbps)9.912.015.018.020.0 HTTP Connections Per Second383 000677 000 1 280 000 1 660 000 2 170 000 HTTP Concurrent Sessions300 000800 000 4 000 0009 000 00018 000 000 SSL throughput (Gbps) 4.38.919.919.919.9 SSL Connections Per Second13002600480074009700 IPSEC yes yes yes yes yes SSLVPN yes yes yes yes yes Protocol TCP (CIFS, SMB, FIX,FTP, IMAP, LDAP, NFS, POP3,RDP, SMTP, SSH), UDP, DHCP,ICMP, RTSP/RTPyes yes yes yes yesRFC2544 and 3511yes yes yes yes yes IPS, Malware, MITRE ATT&CK,FUZZING, and DDOSyes yes yes yes yesReplay — PCAP, Traffic, Attack,GTPyes yes yes yes yesTraffic Mix Enterprise / Lite / Fortinet Mixno Lite only Lite/ Enterprise Lite/ Enterprise/ FortinetEmixLite/ Enterprise/ FortinetEmixTEST CENTER GROUP MEMBERS100FTS-100F2K FTS-2000F, FTS-2500E3K FTS-3000FVM FTS_VM_KVMVM ESXI FTS_VMAWS FTS_VM_AWSAWS_BYOL FTS_VM_AWS_BYOLAZR_BYOL FTS_VM_AZURE_BYOLOCI_BYOL FTS_VM_OCI_BYOLGCP_BYOL FTS_VM_GCP_BYOLIBM_BYOL FTS_VM_IBM_BYOLFortiTester Test Center Mode SupportIn order to run Test Center mode, FortiTester supports grouping similar members above in the same Test Center group.Ordering Information2x vCPU cores and 4 GB memory, supporting VMware/VMXNET3 and KVM/VIRTIO.FC-10-FTV02-294-02-DD Enterprise bundle (IPS attack PCAPs update, malware strike pack, web protection & MITRE ATT&CK signatureupdates), with 24x7 FortiCare support.FortiTester VM04FTS-VM04Network Performance and Security Testing System for Enterprises and Service Providers – Virtual appliance with4x vCPU cores and 8 GB memory, supporting VMware/VMXNET3 and KVM/VIRTIO.FC-10-FTV04-294-02-DD Enterprise bundle (IPS attack PCAPs update, malware strike pack, web protection & MITRE ATT&CK signatureupdates), with 24x7 FortiCare support.FortiTester VM08FTS-VM08Network Performance and Security Testing System for Enterprises and Service Providers – Virtual appliance with8x vCPU cores and 16 GB memory, supporting VMware/VMXNET3 and KVM/VIRTIO.FC-10-FTV08-294-02-DD Enterprise bundle (IPS attack PCAPs update, malware strike pack, web protection & MITRE ATT&CK signatureupdates), with 24x7 FortiCare support.FortiTester VM16FTS-VM16Network Performance and Security Testing System for Enterprises and Service Providers – Virtual appliance with16x vCPU cores and 32 GB memory, supporting VMware/VMXNET3 and KVM/VIRTIO.FC-10-FTV16-294-02-DD Enterprise bundle (IPS attack PCAPs update, malware strike pack, web protection & MITRE ATT&CK signatureupdates), with 24x7 FortiCare support.FortiTester VM32FTS-VM32Network Performance and Security Testing System for Enterprises and Service Providers – Virtual appliance with32x vCPU cores and 64 GB memory, supporting VMware/VMXNET3 and KVM/VIRTIO.FC-10-FTV32-294-02-DD Enterprise bundle (IPS attack PCAPs update, malware strike pack, web protection & MITRE ATT&CK signatureupdates), with 24x7 FortiCare support.Ordering Informationsignature updates), with 24x7 FortiCare support.FC-10-XXXX-187-02-DD FortiTester Premium Attack Signatures (FDS update of IPS attack PCAPs update, plus web protectionsignatures updates).FC-10-XXXX-318-02-DD FortiTester ATT&CK MITRE Attack Package (Windows/ Linux/ Mac attacks based on MITRE techniques).FC-10-XXXX-261-02-DD FortiTester Malware Strike Pack (FortiGuard auto update).XXXX = hardware model such as FT01H, FTE2K, FT2KE, FTK3KSERVICES SKU / UPDATES ENTITLEMENT ENTERPRISE BUNDLE PREMIUM ATTACK SIGNATURES MALWARE STRIKE PACK MITRE ATT&CK IPS✓⃝✓⃝Web Attacks✓⃝✓⃝IOT / SCADA Attacks✓⃝✓⃝Malware Strike Pack✓⃝✓⃝MITRE ATT&CK✓⃝✓⃝Fortinet Corporate Social Responsibility PolicyFortinet is committed to driving progress and sustainability for all through cybersecurity, withrespect for human rights and ethical business practices, making possible a digital world youcan always trust. You represent and warrant to Fortinet that you will not use Fortinet’s productsand services to engage in, or support in any way, violations or abuses of human rights, includingthose involving illegal censorship, surveillance, detention, or excessive use of force. Users ofFortinet products are required to comply with the Fortinet EULA and report any suspectedviolations of the EULA via the procedures outlined in the Fortinet Whistleblower Policy. Copyright © 2023 Fortinet, Inc. All rights reserved. Fortinet, FortiGate, FortiCare and FortiGuard, and certain other marks are registered trademarks of Fortinet, Inc., and other Fortinet names herein may also be registered and/or common law trademarks of Fortinet. All other product or company names may be trademarks of their respective owners. Performance and other metrics contained herein were attained in internal lab tests under ideal conditions, and actual performance and other results may vary. Network variables, different network environments and other conditions may affect performance results. Nothing herein represents any binding commitment by Fortinet, and Fortinet disclaims all warranties, whether express or implied, except to the extent Fortinet enters a binding written contract, signed by Fortinet’s General Counsel, with a purchaser that expressly warrants that the identified product will perform according to certain expressly-identified performance metrics and, in such event, only the specific performance metrics expressly identified in such binding written contract shall be binding on Fortinet. For absolute clarity, any such warranty will be limited to performance in the same ideal conditions as in Fortinet’s internal lab tests. Fortinet disclaims in full any covenants, representations, and guarantees pursuant hereto, whether express or implied. Fortinet reserves the right to change, modify, transfer, or otherwise revise this publication without notice, and the most current version of the publication shall be applicable.November 2, 2023FTS-DAT-R20-20231102。
常规检验项目的性能验证
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(1) Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-
The U.S. CLIA Rules
Sec. 493.1253 Standard: Establishment and verification of performance specifications
(a) Applicability. Laboratories are not required to verify or establish performance specifications for any
(2) Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or
approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures, Gram stain, or potassium hydroxide preparations), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:
数据完整性法规的解读与实验室数据的管理审查
Laboratory informatics Product Specialist 3/24/2016
FDA Compliance Update - 2007
31st International GMP Conference – Athens 雅典, • Presentation from Edwin Rivera Martinez, Chief Investigations and Preapproval Compliance Branch “Data Integrity and Fraud - Another Looming Crisis?” 数据完整性和欺诈 - 另一种迫在眉睫的危机 在美国发现的问题 : • 有意计算机操作色谱图，通过剪切和粘贴色谱数据，使 得不合规格测试结果被认定为合格 • 改变样品的分析计算重量和标准
用户 个人电脑 HPLC/GC 设备 测量 A 设备控制 数据采集 原始数据分析 数据处理 B,C,D,E,F,G 服务器 数据库 存档 备份 查找 C,D, E,F,G 建议
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保持电子记录的原始 格式
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事件 A. 数据生成 B. 原始数据处理 C. 原始数据保存 D. 用户有权限进入 E. 用户有权限处理数据 F. 批准 G. 授权进入
Part 11
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Confidentiality Label 7 March 24, 2016
什么是 21 CFR Part 11