DIN EN ISO 16256-2013 Clinical laboratory testing and in vitro diagnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast of6.pdf
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1、April 2013 Translation by DIN-Sprachendienst.English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.100.10!$A“1999330www.din.deDDIN EN ISO 16256Clinical laboratory testing and in vitro diagnostic test systems Reference method for testing the in vitro activity of antimicrobial agentsagainst yeast fungi involved in infectious diseases (ISO 16256:2012);English version EN ISO 16256:2012,English tra
3、nslation of DIN EN ISO 16256:2013-04Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme Referenzmethode zur Testung der In-vitro-Aktivitt von antimikrobiellen Substanzengegen Pilze, die Infektionskrankheiten verursachen (ISO 16256:2012);Englische Fassung EN ISO 16256:2012,Englische ber
4、setzung von DIN EN ISO 16256:2013-04Essais de laboratoire clinique et systmes de diagnostic in vitro Mthode de rfrence pour soumettre essai lactivit in vitro des agents antimicrobienspar rapport aux levures impliques dans les maladies infectieuses (ISO 16256:2012);Version anglaise EN ISO 16256:2012,
5、Traduction anglaise de DIN EN ISO 16256:2013-04www.beuth.deDocument comprises 24 pagesIn case of doubt, the German-language original shall be considered authoritative.03.13DIN EN ISO 16256:2013-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 16256:2012) has been p
6、repared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its pr
7、eparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-05-10 AA Chemotherapeutische Untersuchungsmethoden. EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16256 December 2012 ICS 11.100.10 English Version Clinical laboratory testing and in vitro di
8、agnostic test systems - Reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2012) Essais de laboratoire clinique et systmes de diagnostic in vitro - Mthode de rfrence pour soumettre essai lactivit in vitro des agen
9、ts antimicrobiens par rapport aux levures impliques dans les maladies infectieuses (ISO 16256:2012) Labormedizinische Untersuchungen und In-vitro-Diagnostika-Systeme - Referenzmethode zur Testung der In-vitro-Aktivitt von antimikrobiellen Substanzen gegen Pilze, die Infektionskrankheiten verursachen
10、 (ISO 16256:2012) This European Standard was approved by CEN on 30 November 2012. 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
11、bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 re
12、sponsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav
13、Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE N
14、ORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16256:2012: EContents PageForeword .Introduction .1 Scope 2 Terms and definit
15、ions 3 Test procedures 3.1 General 3.2 Medium .3.3 Antifungal agents .3.4 Storage of microdilution trays .3.5 Preparation of inoculum General .3.6 Inoculation of microdilution trays .3.7 Incubation of microdilution trays .3.8 Reading MIC results 3.9 Interpretation of MICs 144 Quality control (QC) 14
16、Annex A (informative) RPMI-1640 medium .17Annex B (informative) McFarland 0,5 barium sulfate turbidity standard Annex C (informative) Acceptable reading times for MIC interpretations using the visual MIC reading procedure Bibliography 345588891112121313192021EN ISO 16256:2012 (E) DIN EN ISO 16256:20
17、13-04 2Foreword This document (EN ISO 16256:2012) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices”, the secretariat of which is held by DIN
18、. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2013, and conflicting national standards shall be withdrawn at the latest by December 2015. Attention is drawn to the possibility that some o
19、f the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to impleme
20、nt this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, S
21、lovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16256:2012 has been approved by CEN as a EN ISO 16256:2012 without any modification. EN ISO 16256:2012 (E) DIN EN ISO 16256:2013-04 3 IntroductionIn vitro susceptibility tests are perform
22、ed on microorganisms suspected of causing disease, particularly if the organism is thought to belong to a species that may exhibit acquired resistance to frequently used antimicrobial agents. The tests are also important in resistance surveillance, epidemiological studies of susceptibility and in co
23、mparisons of new and existing agents.Dilution procedures are used to determine the minimum inhibitory concentrations (MICs) of antimicrobial agents and represent the reference method for antifungal susceptibility testing. MIC methods are used in resistance surveillance, comparative testing of new ag
24、ents for research or registration purposes, to establish the susceptibility of organisms that give equivocal results in routine tests, for tests with organisms where routine tests may be unreliable and when a quantitative result is needed for clinical management. In dilution tests, microorganisms ar
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