欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    BS EN ISO 20776-2-2007 Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial sa.pdf

    • 资源ID:581629       资源大小:438.39KB        全文页数:18页
    • 资源格式: PDF        下载积分:10000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要10000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    BS EN ISO 20776-2-2007 Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial sa.pdf

    1、Susceptibility testing of g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58infectious agents and evaluation of performance of antimicrobial susceptib

    2、ility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devicesThe European Standard EN ISO 20776-2:2007 has the status of a British StandardICS 11.100.20Clinical laboratory testing and in vitro diagnostic test systems BRITISH STANDARDBS EN ISO 20776-2:2007BS EN ISO

    3、 20776-2:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2007 BSI 2007ISBN 978 0 580 54118 6Amendments issued since publicationAmd. No. Date CommentsCompliance with a British Standard cannot confer immunity from legal obligations.

    4、National forewordThis British Standard is the UK implementation of EN ISO 20776-2:2007. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does no

    5、t purport to include all the necessary provisions of a contract. Users are responsible for its correct application.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 20776-2July 2007ICS 11.100.20English VersionClinical laboratory testing and in vitro diagnostic test systems -Susceptibility testin

    6、g of infectious agents and evaluation ofperformance of antimicrobial susceptibility test devices - Part 2:Evaluation of performance of antimicrobial susceptibility testdevices (ISO 20776-2:2007)Systmes dessais en laboratoire et de diagnostic in vitro -Sensibilit in vitro des agents infectieux et val

    7、uation desperformances des dispositifs pour antibiogrammes - Partie2: valuation des performances des dispositifs pourantibiogrammes (ISO 20776-2:2007)Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Empfindlickeitsprfung vonInfektionserregern und Evalution von Gerten zurantimikrob

    8、iellen Empfindlichkeitsprfung - Teil 2: Evalutionder Leistung einer Vorrichtung zur antimikrobiellenEmpfindlichkeitsprfung (ISO 20776-2:2007)This European Standard was approved by CEN on 24 June 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the condit

    9、ions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three of

    10、ficial versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria,

    11、 Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE F

    12、OR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 20776-2:2007: EForeword This document (EN I

    13、SO 20776-2:2007) has been prepared by Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“, the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“. This European Standard shall b

    14、e given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2008, and conflicting national standards shall be withdrawn at the latest by January 2008. According to the CEN/CENELEC Internal Regulations, the national standards organ

    15、izations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Ro

    16、mania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN ISO 20776-2:2007Reference numberISO 20776-2:2007(E)INTERNATIONAL STANDARD ISO20776-2First edition2007-07-01Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and eva

    17、luation of performance of antimicrobial susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices Systmes dessais en laboratoire et de diagnostic in vitro Sensibilit in vitro des agents infectieux et valuation des performances des dispositifs pour ant

    18、ibiogrammes Partie 2: valuation des performances des dispositifs pour antibiogrammes EN ISO 20776-2:2007ii iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is

    19、 normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part

    20、 in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to pr

    21、epare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that

    22、 some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 20776-2 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical device

    23、s, in collaboration with Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). ISO 20776 consists of the following parts, under the general title Clinical lab

    24、oratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices: Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria inv

    25、olved in infectious diseases Part 2: Evaluation of performance of antimicrobial susceptibility test devices EN ISO 20776-2:2007blank1Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibil

    26、ity test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices 1 Scope This part of ISO 20776 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or int

    27、erpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. This part of ISO 20776 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such de

    28、vices. It defines how a performance evaluation of an AST device is to be conducted. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies. 2 Normative references The following referenced documents are indispensable for the application of th

    29、is document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 20776-1, Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and e

    30、valuation of performance of antimicrobial susceptibility test devices Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases 3 Terms and definitions For the purposes of this document, the following t

    31、erms and definitions apply. 3.1 Agreement of test results 3.1.1 category agreement CA agreement of SIR results between a breakpoint test or an MIC test and the reference method (ISO 20776-1) Another representation of the concept: CA100NNEN ISO 20776-2:20072 where NCAis the number of bacterial isolat

    32、es with the same SIR category as the reference method category result; N is the total number of bacterial isolates tested NOTE The overall CA is expressed as a percentage. 3.1.2 essential agreement EA MIC result obtained with the AST device that is within plus or minus one doubling dilution step fro

    33、m the MIC value established with the reference method (ISO 20776-1) Another representation of the concept: EA100NNwhere NEAis the number of bacterial isolates with an EA; N is the total number of bacterial isolates tested NOTE The overall EA is expressed as a percentage. 3.2 antimicrobial susceptibi

    34、lity test device AST device device including all specified components used to obtain test results that allow SIR categorization of bacteria with specific antimicrobial agents NOTE Specific components include inoculators, disposables and reagents, media, disks and readers. Non-specific components, su

    35、ch as swabs, pipettes and tubes, are not part of the device. 3.3 breakpoint BP specific values of parameters, such as MICs, on the basis of which bacteria can be assigned to the clinical categories “susceptible”, “intermediate” and “resistant” NOTE For current interpretive breakpoints, reference can

    36、 be made to the latest publications of organizations employing this reference method (e.g. CLSI and EUCAST). 3.3.1 susceptible S bacterial strain inhibited in vitro by a concentration of an antimicrobial agent that is associated with a high likelihood of therapeutic success NOTE 1 Bacterial strains

    37、are categorized as susceptible by applying the appropriate breakpoints in a defined phenotypic test system. NOTE 2 This breakpoint can be altered due to changes in circumstances (e.g. changes in commonly used drug dosages, emergence of new resistance mechanisms). EN ISO 20776-2:200733.3.2 intermedia

    38、te I bacterial strain inhibited in vitro by a concentration of an antimicrobial agent that is associated with uncertain therapeutic effect NOTE 1 Bacterial strains are categorized as intermediate by applying the appropriate breakpoints in a defined phenotypic test system. NOTE 2 This class of suscep

    39、tibility implies that an infection due to the isolate can be appropriately treated in body sites where the drugs are physiologically concentrated or when a high dosage of drug can be used. NOTE 3 This class also indicates a “buffer zone”, to prevent small, uncontrolled, technical factors from causin

    40、g major discrepancies in interpretations. NOTE 4 These breakpoints can be altered due to changes in circumstances (e.g. changes in commonly used drug dosages, emergence of new resistance mechanisms). 3.3.3 resistant R bacterial strain inhibited in vitro by a concentration of an antimicrobial agent t

    41、hat is associated with a high likelihood of therapeutic failure NOTE 1 Bacterial strains are categorized as resistant by applying the appropriate breakpoints in a defined phenotypic test system. NOTE 2 This breakpoint can be altered due to changes in circumstances (e.g. changes in commonly used drug

    42、 dosages, emergence of new resistance mechanisms). 3.3.4 non-susceptible NS bacterial strain for which the test result exceeds the susceptible breakpoint and for which there are no established intermediate or resistant breakpoints NOTE This is generally due to lack of strains with resistance to the

    43、antimicrobial agent when the breakpoints are defined. 3.4 breakpoint test BPT test that has the principal objective to provide categorical results (SIR) NOTE This can include limited range dilution tests or diffusion tests. 3.5 coordinator person empowered by the manufacturer or investigator with re

    44、sponsibility for the entire performance evaluation 3.6 Discrepancies 3.6.1 major discrepancy MD test result by the reference method interpreted as S and an AST device result of R Another representation of the concept: MDSREF100NNEN ISO 20776-2:20074 where NMDis the number of tests that result in a M

    45、D; NSREFis the number of susceptible bacterial isolates as determined by the reference method (ISO 20776-1) NOTE The overall MD is expressed as a percentage. 3.6.2 minor discrepancy mD test result by the reference method interpreted as R or S and an AST device result of I; or a reference result inte

    46、rpreted as I and an AST device result of R or S Another representation of the concept: mD100NNwhere NmDis the number of tests that result in a mD; N is the total number of bacterial isolates tested NOTE The overall mD is expressed as a percentage. 3.6.3 very major discrepancy VMD test result by the

    47、reference method interpreted as R and an AST device result of S Another representation of the concept: VMDRREF100NNwhere NVMD is the number of tests that result in a VMD; NRREFis the number of resistant bacterial isolates as determined by the reference method (ISO 20776-1) NOTE The overall VMD is ex

    48、pressed as a percentage. 3.7 evaluation plan description of a planned performance evaluation 3.8 evaluation report description of and conclusions from a performance evaluation EN ISO 20776-2:200753.9 Clinical isolates 3.9.1 fresh isolate isolate recovered from a clinical sample within the previous s

    49、even days that has not been frozen or subcultured more than five times 3.9.2 recent isolate isolate recovered from a clinical sample within the previous twelve months 3.9.3 stock isolate isolate recovered from a clinical sample that has been retained, stored or obtained from a culture collection NOTE Stock isolates are usually included because they have known or rare resistance mechanisms, or are of a genus or species for which the antimicrobial agent is indicated but are not commonly isolated. Such organisms are unlikely to be available in


    注意事项

    本文(BS EN ISO 20776-2-2007 Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial sa.pdf)为本站会员(fuellot230)主动上传,麦多课文档分享仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开