1、September 2017 English price group 15No 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 07.100.40!%mPr“2744579www.din.
2、deDIN EN ISO 21148Cosmetics Microbiology General instructions for microbiological examination (ISO 21148:2017);English version EN ISO 21148:2017,English translation of DIN EN ISO 21148:2017-09Kosmetische Mittel Mikrobiologie Allgemeine Anleitungen zur mikrobiologischen Untersuchung (ISO 21148:2017);
3、Englische Fassung EN ISO 21148:2017,Englische bersetzung von DIN EN ISO 21148:2017-09Cosmtiques Microbiologie Instructions gnrales pour les examens microbiologiques (ISO 21148:2017);Version anglaise EN ISO 21148:2017,Traduction anglaise de DIN EN ISO 21148:2017-09SupersedesDIN EN ISO 21148:200910www
4、.beuth.deDocument comprises 31 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.08.17 DIN EN ISO 21148:2017-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 21148:2017) has been prepared by Tec
5、hnical Committee ISO/TC 217 “Cosmetics” (Secretariat: ISIRI, Iran) in collaboration with Technical Committee CEN/TC 392 “Cosmetics” (Secretariat: AFNOR, France). The responsible German body involved in its preparation was DIN-Normenausschuss Lebensmittel und landwirtschaftliche Produkte (DIN Standar
6、ds Committee Food and Agricultural Products), Working Committee NA 057-07-01 AA “Cosmetics”. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 6887-1 DIN EN ISO 6887-1 ISO 7218 DIN EN ISO 7218 ISO 11133 DIN EN ISO 11133 ISO/IEC 17025 DIN
7、EN ISO/IEC 17025 Amendments This standard differs from DIN EN ISO 21148:2009-10 as follows: a) in the Introduction, “validated” has been changed to “demonstrated to be suitable”; b) normative references have been updated; c) in Clause 6, “validation of the methodology” has been changed to “verificat
8、ion of thesuitability”; d) in 8.2.1, “validated” has been changed to “demonstrated to be suitable”; e) in Clause 13, “validated” has been changed to “demonstrated”; f) in A.5, “validated” has been changed to “demonstrated to be suitable”; g) the term “validation” (in the German version Validierung)
9、has been replaced throughout the text by “suitability” (in the German version Eignung); h) the standard has been editorially revised. Previous editions DIN EN ISO 21148: 2009-10 methods DIN EN ISO 21148:2017-09 3 National Annex NA (informative) Bibliography DIN EN ISO 6887-1, Microbiology the food c
10、hain Preparation of test samples, initial suspension and decimal dilutions for microbiological examination Part 1: General rules for the preparation of the initial suspension and decimal dilutions DIN EN ISO 7218, Microbiology of food and animal feeding stuffs General requirements and guidance for m
11、icrobiological examinations DIN EN ISO 11133, Microbiology of food, animal feed and water Preparation, production, storage and performance testing of culture media DIN EN ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories DIN EN ISO 21148:2017-09 4 This pa
12、ge is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21148 June 2017 ICS 07.100.99; 71.100.70 Supersedes EN ISO 21148:2009English Version Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017) Cosmtiques - Microbiologie - Instru
13、ctions gnrales pour les examens microbiologiques (ISO 21148:2017)Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen Untersuchung(ISO 21148:2017) This European Standard was approved by CEN on 26 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal R
14、egulations 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 be obtained on application to the CEN-CENELEC Management Centre or to any CEN m
15、ember. 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-CENELEC Management Centre has the same status as the official versions
16、. CEN members are the national standards bodies 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, Pola
17、nd, Portugal, Romania, Serbia, Slovakia, Slovenia, 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 explo
18、itation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21148:2017 EEuropean foreword 4Introduction 61 Scope . 72 Normative references 73 Terms and definitions . 74 Premises 74.1 Test areas . 74.2 Additional areas . 84.3 Location of the premises 84.4 Equippi
19、ng the premises 84.5 Maintenance 95 Equipment . 95.1 General . 95.2 Microbiological cabinets . 95.3 Balances 95.4 Homogenizer . 105.5 pHmeter 105.6 Autoclave . 105.7 Incubator . 105.8 Water baths . 105.9 Refrigerator or cold-storage room 105.10 Freezer 105.11 Sterilizing oven 115.12 Colony-counting
20、device 115.13 Other equipment 116 Strains of microorganisms 117 Personnel 127.1 Competence 127.2 Hygiene . 128 Preparation of the apparatus and glassware . 128.1 Preparation . 128.2 Sterilization . 128.2.1 Sterilization by dry heat . 128.2.2 Sterilization by moist heat 138.3 Disposable apparatus . 1
21、38.4 Management of clean apparatus and glassware . 138.5 Management of sterile apparatus and glassware . 138.6 Treatment of contaminated material 138.7 Washing 139 Preparation and sterilization of culture media and reagents 149.1 General 149.2 Water 149.3 Preparation of culture media . 149.3.1 Gener
22、al. 149.3.2 Rehydration . 149.3.3 Measurement of pH 149.3.4 Dispensing 14Contents PageDIN EN ISO 21148:2017-09 EN ISO 21148:2017 (E) 2Foreword 59.5 Storage 159.5.1 General. 159.5.2 Laboratory-prepared culture media and reagents 159.5.3 Ready-to-use culture media and reagents 169.6 Melting of agar cu
23、lture media . 169.7 Preparation of Petri dishes 1610 Laboratory samples 1610.1 General 1610.2 Sampling the cosmetic product . 1610.3 Transport 1610.4 Receipt and storage 1710.5 Handling products and samples 1710.6 Conservation and destruction of products 1711 Operating practices 1711.1 Hygienic prec
24、autions during the testing 1711.2 Preparation of the initial suspension and of sample dilutions .1811.2.1 General. 1811.2.2 Water-miscible product 1811.2.3 Water-immiscible products . 1911.3 Counting methods . 1911.4 Detection methods 1912 Expression of results .1913 Neutralization of the antimicrob
25、ial properties of the product .19Annex A (informative) Basic identification techniques .20Annex B (informative) Basic techniques for counting and plating 25Annex C (informative) Preparation and calibration of inoculums .26Bibliography .279.4 Sterilization . 159.4.1 General. 159.4.2 Sterilization by
26、moist heat 159.4.3 Sterilization by filtration 15DIN EN ISO 21148:2017-09 EN ISO 21148:2017 (E) 3 European foreword This document (EN ISO 21148:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of wh
27、ich is held by AFNOR. 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 December 2017, and conflicting national standards shall be withdrawn at the latest by December 2017. Attention is drawn to the
28、 possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21148:2009. This document has been prepared under a mandate given to CEN by the European Commi
29、ssion and the European Free Trade Association. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, For
30、mer Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of I
31、SO 21148:2017 has been approved by CEN as EN ISO 21148:2017 without any modification. DIN EN ISO 21148:2017-09 EN ISO 21148:2017 (E) 4 ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing In
32、ternational 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. International organizations, governmental and non-governmental, in liaison
33、with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directi
34、ves, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that so
35、me 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declar
36、ations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity
37、 assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 217, Cosmetics.This second edition can
38、cels and replaces the first edition (ISO 21148:2005), of which it constitutes a minor revision.It also incorporates the Technical Corrigendum ISO 21148:2005/Cor 1:2006.The following changes have been made:a) in the Introduction, “validated” was changed to “demonstrated to be suitable”;b) in Clause 6
39、, “validation of the methodology” was changed to “verification of the methods suitability”;c) in 8.2.1, “validated” was changed to “demonstrated to be suitable”;d) in Clause 13, “validated” was changed to “demonstrated”;e) in A.5, “validated” was changed to “demonstrated to be suitable”;f) in B.3, e
40、ditorial changes were applied.DIN EN ISO 21148:2017-09 EN ISO 21148:2017 (E) 5 IntroductionThe purpose of this document is to help ensure that the general techniques used for conducting cosmetic microbiological examinations are the same in other laboratories that adopt these standards, to help achie
41、ve homogeneous results in different laboratories and to contribute towards the protection of the health of the laboratory personnel by preventing risk of infection.When conducting microbiological examinations for cosmetic products, it is especially important that: only those microorganisms which are
42、 present in the samples be isolated or enumerated; the microorganisms do not contaminate the environment.In order to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques which ensure, as far as possible, exclusion of extraneous contamination.Since, in this
43、 document, it is possible to give only a few examples of the precautions to be taken during microbiological examinations, a thorough knowledge of the microbiological techniques and of the microorganisms involved is essential. It is important that the analyses be conducted as accurately as possible,
44、including calculation of the number of microorganisms.A large number of manipulations can, for example, unintentionally lead to cross-contamination and the analyst should always verify the accuracy of the results given by his/her technique. It is necessary to take special precautions, not only for r
45、easons of hygiene, but also to ensure good reproducibility of the results. It is not possible to specify all the precautions to be taken in all circumstances, but this document at least provides the main measures to be taken when preparing, sterilizing and storing the media and the equipment.The giv
46、en recommendations will allow enumeration and detection of mesophilic microorganisms which may grow under aerobic conditions.The recommendations are applicable to the determination of the absence of, or limited occurrence of specified microorganisms that are of interest for cosmetic products.The tes
47、t methods are described in the individual standards. Alternative microbiological procedures can be used provided that their equivalence has been demonstrated or the method has been otherwise demonstrated to be suitable. The choice of a specific method, or combination of methods mentioned in these In
48、ternational Standards will depend on the purpose for performing the test and it is for the user to decide which approach is best for his/her application.DIN EN ISO 21148:2017-09 EN ISO 21148:2017 (E) 6 1 ScopeThis document gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme
