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1、BRITISH STANDARD 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 susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devic
2、es The European Standard EN ISO 20776-2:2007 has the status of a British Standard ICS 11.100.20 ? Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 20776-2:2007 This British Standard was published under
3、 the authority of the Standards Policy and Strategy Committee on 31 July 2007 BSI 2007 ISBN 978 0 580 54118 6 National foreword This 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
4、organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal ob
5、ligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20776-2 July 2007 ICS 11.100.20 Engl
6、ish Version Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007) Sy
7、stmes dessais en laboratoire et de diagnostic in vitro - Sensibilit in vitro des agents infectieux et valuation des performances des dispositifs pour antibiogrammes - Partie 2: valuation des performances des dispositifs pour antibiogrammes (ISO 20776-2:2007) Labormedizinische Untersuchungen und In-v
8、itro- Diagnostika-Systeme - Empfindlickeitsprfung von Infektionserregern und Evalution von Gerten zur antimikrobiellen Empfindlichkeitsprfung - Teil 2: Evalution der Leistung einer Vorrichtung zur antimikrobiellen Empfindlichkeitsprfung (ISO 20776-2:2007) This European Standard was approved by CEN o
9、n 24 June 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may
10、be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN
11、 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland
12、s, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in a
13、ny form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20776-2:2007: E Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 20776-2:2007) has been prepar
14、ed 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 be given the status of a national
15、 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 organizations of the following countr
16、ies 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, Romania, Slovakia, Slovenia, Spain
17、, Sweden, Switzerland and United Kingdom. EN ISO 20776-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 20776-2:2007(E) INTERNATIONAL STANDARD ISO 20776-2 First edition 2007-07-01 Cli
18、nical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices Systmes dessais en laboratoire et de dia
19、gnostic in vitro Sensibilit in vitro des agents infectieux et valuation des performances des dispositifs pour antibiogrammes Partie 2: valuation des performances des dispositifs pour antibiogrammes EN ISO 20776-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug
20、 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of nati
21、onal standards bodies (ISO member bodies). The work of preparing International Standards is 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. Internat
22、ional organizations, governmental and non-governmental, in liaison with ISO, also take part 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 ru
23、les given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare 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
24、 least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that 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 f
25、or Standardization (CEN) Technical Committee CEN/TC 140, In vitro diagnostic medical devices, 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
26、Agreement). ISO 20776 consists of the following parts, under the general title Clinical laboratory 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
27、 the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases Part 2: Evaluation of performance of antimicrobial susceptibility test devices EN ISO 20776-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Au
28、g 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI blank Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 1 Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infect
29、ious agents and evaluation of performance of antimicrobial susceptibility 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 ar
30、e used to determine minimum inhibitory concentrations (MIC) and/or interpretive 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 diffu
31、sion test systems) and procedures for assessing performance of such devices. 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 foll
32、owing referenced documents are indispensable for the application of this 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 dia
33、gnostic 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 involved in infectious diseases 3 Te
34、rms and definitions For the purposes of this document, the following terms 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:
35、CA 100N N EN ISO 20776-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 2 where NCA is the number of bacterial isolates with the same SIR category as the reference method category result; N is the total n
36、umber 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 from the MIC value established with the reference method (ISO 20776-1) Another representat
37、ion of the concept: EA 100N N where NEA is 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 susceptibility test device AST device device including all specified components used to obtai
38、n 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, such as swabs, pipettes and tubes, are not part of the device. 3.3 breakpoint BP spec
39、ific 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 be made to the latest publications of organizations employing this reference metho
40、d (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 are categorized as susceptible by applying the appropriate breakpoints in a defined
41、 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 20776-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+
42、00:00 2007, Uncontrolled Copy, (c) BSI 3 3.3.2 intermediate 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 de
43、fined phenotypic test system. NOTE 2 This class of susceptibility 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 p
44、revent small, uncontrolled, technical factors from causing 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 inhibite
45、d in vitro by a concentration of an antimicrobial agent that 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 cha
46、nges in circumstances (e.g. changes in commonly used drug 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
47、 generally due to lack of strains with resistance to the 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 per
48、son empowered by the manufacturer or investigator with responsibility 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: MD SREF 100N N EN ISO 207
49、76-2:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Aug 08 03:50:59 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 4 where NMD is the number of tests that result in a MD; NSREF is 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 o