DIN EN ISO 11138-3-2017 Sterilization of health care products - Biological indicators - Part 3 Biological indicators for moist heat sterilization processes (ISO 11138-3 2017) Germa.pdf
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1、July 2017 English price group 11No 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 11.080.20!%guZ“2688255www.din.deDIN
2、 EN ISO 11138-3Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes (ISO 111383:2017);English version EN ISO 111383:2017,English translation of DIN EN ISO 11138-3:2017-07Sterilisation von Produkten fr die Gesundheitsfrsorge
3、Biologische Indikatoren Teil 3: Biologische Indikatoren fr Sterilisationsverfahren mit feuchter Hitze (ISO 111383:2017);Englische Fassung EN ISO 111383:2017,Englische bersetzung von DIN EN ISO 11138-3:2017-07Strilisation des produits de sant Indicateurs biologiques Partie 3: Indicateurs biologiques
4、pour la strilisation la chaleur humide (ISO 111383:2017);Version anglaise EN ISO 111383:2017,Traduction anglaise de DIN EN ISO 11138-3:2017-07SupersedesDIN EN ISO 111383:200909www.beuth.deDocument comprises 17 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original sha
5、ll be considered authoritative.06.17 DIN EN ISO 11138-3:2017-07 2 A comma is used as the decimal marker. National foreword This document (EN ISO 11138-3:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products” in collaboration with Technical Committee CEN/TC
6、102 “Sterilizers and associated equipment for processing of medical devices” (Secretariat: DIN, Germany), with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA
7、063-04-08 AA “Indicators”. DIN EN ISO 11138 consists of the following parts, under the general title Sterilization of health care products Biological indicators: Part 1: General requirements Part 2: Biological indicators for ethylene oxide sterilization processes Part 3: Biological indicators for mo
8、ist heat sterilization processes Part 4: Biological indicators for dry heat sterilization processes Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes The DIN Standards corresponding to the International Standards referred to in this document are as foll
9、ows: ISO 11138-1 DIN EN ISO 11138-1 ISO 14161 DIN EN ISO 14161 ISO 17665-1 DIN EN ISO 17665-1 ISO 18472 DIN EN ISO 18472 Amendments This standard differs from DIN EN ISO 11138-3:2009-09 as follows: a) Clause 9 containing requirements for population and resistance has been revised; b) Annex A, in par
10、ticular A.2.4, step 4, has been revised; c) Annex ZA (informative) “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been deleted; d) the standard has been editorially revised. Previous editions DIN EN 866-3: 1997-05 DIN EN 866-7: 2000-01 DIN
11、EN ISO 11138-3: 2006-10, 2009-09 DIN EN ISO 11138-3:2017-07 3 National Annex NA (informative) Bibliography DIN EN ISO 11138-1, Sterilization of health care products Biological indicators Part 1: General requirements DIN EN ISO 14161, Sterilization of health care products Biological indicators Guidan
12、ce for the selection, use and interpretation of results DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 18472, Sterilization of health care products Bio
13、logical and chemical indicators Test equipment DIN EN ISO 11138-3:2017-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11138-3 March 2017 ICS 11.080.20 Supersedes EN ISO 11138-3:2009English Version Sterilization of health care products - Biological indi
14、cators -Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017) Strilisation des produits de sant - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la strilisation la chaleur humide (ISO 11138-3:2017) Sterilisation von Produkten fr die Gesundheitsfrso
15、rge - Biologische Indikatoren - Teil 3: Biologische Indikatoren fr Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017) This European Standard was approved by CEN on 19 January 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
16、 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 be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three
17、 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodi
18、es of 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, Serbia, Slovakia, Slov
19、enia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved
20、 worldwide for CEN national Members. Ref. No. EN ISO 11138-3:2017 EEuropean foreword . 3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 General requirements . 65 Test organism . 66 Suspension 77 Carrier and primary packaging 78 Inoculated carriers and biological indicat
21、ors 79 Population and resistance 7Annex A (normative) Method for determination of resistance to moist heat sterilization . 9Annex B (normative) Calculation of z value and coefficient of determination, r2. 10Bibliography . 13Contents PageDIN EN ISO 11138-3:2017-07 EN ISO 11138-3:2017 (E) 2Foreword 4E
22、uropean foreword This document (EN ISO 11138-3:2017) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products in collaboration with Technical Committee CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is h
23、eld by DIN. 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 September 2017 and conflicting national standards shall be withdrawn at the latest by September 2017. Attention is drawn to the possibil
24、ity that some of 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. This document supersedes EN ISO 11138-3:2009. The standard is a full technical revision of the previous version. The fol
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