EN ISO 21148-2017 en Cosmetics - Microbiology - General instructions for microbiological examination.pdf

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1、Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017) BS EN ISO 21148:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21148 June 2017 ICS 07.100.99; 71.100.70 Supe

2、rsedes EN ISO 21148:2009English Version Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017) Cosmtiques - Microbiologie - Instructions gnrales pour les examens microbiologiques (ISO 21148:2017)Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur

3、 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 Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alter

4、ation. 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 official versions (English, French, German). A version in any other language made

5、 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 bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estoni

6、a, Finland, Former 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 United Kingdom. EUROPEAN COMMITTEE FO

7、R 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 worldwide for CEN national Members. Ref. No. EN ISO 21148:2017 ENational foreword

8、This British Standard is the UK implementation of EN ISO 21148:2017. It is identical to ISO 21148:2017. It supersedes BS EN ISO 21148:2009, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this co

9、mmittee 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. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 95715 4ICS 71.1

10、00.70; 07.100.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS

11、 EN ISO 21148:2017EUROPEAN 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 - Instructions g

12、nrales 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 Regulati

13、ons 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 member.

14、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. CEN m

15、embers 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, Poland, Por

16、tugal, 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 exploitation

17、 in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21148:2017 EBS EN ISO 21148:2017EN 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 Commi

18、ttee CEN/TC 392 “Cosmetics” the secretariat of which 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 l

19、atest by December 2017. Attention is drawn to the 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 u

20、nder a mandate given to CEN by the European Commission 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, Cypru

21、s, 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, Slovenia, Spain, Sweden, Switzerland, Turkey and the

22、 United Kingdom. Endorsement notice The text of ISO 21148:2017 has been approved by CEN as EN ISO 21148:2017 without any modification. ISO 21148:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Premises 14.1 Test areas . 14.2 Additional areas . 24.3 Loc

23、ation of the premises 24.4 Equipping the premises 24.5 Maintenance 35 Equipment . 35.1 General . 35.2 Microbiological cabinets . 35.3 Balances 35.4 Homogenizer 45.5 pHmeter . 45.6 Autoclave 45.7 Incubator 45.8 Water baths 45.9 Refrigerator or cold-storage room . 45.10 Freezer . 45.11 Sterilizing ove

24、n . 55.12 Colony-counting device . 55.13 Other equipment . 56 Strains of microorganisms . 57 Personnel . 67.1 Competence . 67.2 Hygiene 68 Preparation of the apparatus and glassware 68.1 Preparation 68.2 Sterilization 68.2.1 Sterilization by dry heat 68.2.2 Sterilization by moist heat . 78.3 Disposa

25、ble apparatus 78.4 Management of clean apparatus and glassware 78.5 Management of sterile apparatus and glassware 78.6 Treatment of contaminated material . 78.7 Washing . 79 Preparation and sterilization of culture media and reagents . 89.1 General . 89.2 Water . 89.3 Preparation of culture media 89

26、.3.1 General 89.3.2 Rehydration 89.3.3 Measurement of pH . 89.3.4 Dispensing . 89.4 Sterilization 99.4.1 General 99.4.2 Sterilization by moist heat . 99.4.3 Sterilization by filtration . 9 ISO 2017 All rights reserved iiiContents PageBS EN ISO 21148:2017ISO 21148:2017(E)Foreword vIntroduction vi1 Sc

27、ope . 12 Normative references 13 Terms and definitions . 14 Premises 14.1 Test areas . 14.2 Additional areas . 24.3 Location of the premises 24.4 Equipping the premises 24.5 Maintenance 35 Equipment . 35.1 General . 35.2 Microbiological cabinets . 35.3 Balances 35.4 Homogenizer 45.5 pHmeter . 45.6 A

28、utoclave 45.7 Incubator 45.8 Water baths 45.9 Refrigerator or cold-storage room . 45.10 Freezer . 45.11 Sterilizing oven . 55.12 Colony-counting device . 55.13 Other equipment . 56 Strains of microorganisms . 57 Personnel . 67.1 Competence . 67.2 Hygiene 68 Preparation of the apparatus and glassware

29、 68.1 Preparation 68.2 Sterilization 68.2.1 Sterilization by dry heat 68.2.2 Sterilization by moist heat . 78.3 Disposable apparatus 78.4 Management of clean apparatus and glassware 78.5 Management of sterile apparatus and glassware 78.6 Treatment of contaminated material . 78.7 Washing . 79 Prepara

30、tion and sterilization of culture media and reagents . 89.1 General . 89.2 Water . 89.3 Preparation of culture media 89.3.1 General 89.3.2 Rehydration 89.3.3 Measurement of pH . 89.3.4 Dispensing . 89.4 Sterilization 99.4.1 General 99.4.2 Sterilization by moist heat . 99.4.3 Sterilization by filtrat

31、ion . 9 ISO 2017 All rights reserved iiiContents PageBS EN ISO 21148:2017ISO 21148:2017(E)9.5 Storage . 99.5.1 General 99.5.2 Laboratory-prepared culture media and reagents . 99.5.3 Ready-to-use culture media and reagents 109.6 Melting of agar culture media . 109.7 Preparation of Petri dishes 1010 L

32、aboratory samples 1010.1 General 1010.2 Sampling the cosmetic product . 1010.3 Transport 1010.4 Receipt and storage 1110.5 Handling products and samples 1110.6 Conservation and destruction of products 1111 Operating practices 1111.1 Hygienic precautions during the testing 1111.2 Preparation of the i

33、nitial suspension and of sample dilutions .1211.2.1 General. 1211.2.2 Water-miscible product 1211.2.3 Water-immiscible products . 1311.3 Counting methods . 1311.4 Detection methods 1312 Expression of results .1313 Neutralization of the antimicrobial properties of the product .13Annex A (informative)

34、 Basic identification techniques .14Annex B (informative) Basic techniques for counting and plating 19Annex C (informative) Preparation and calibration of inoculums .20Bibliography .21iv ISO 2017 All rights reservedBS EN ISO 21148:2017ISO 21148:2017(E)9.5 Storage . 99.5.1 General 99.5.2 Laboratory-p

35、repared culture media and reagents . 99.5.3 Ready-to-use culture media and reagents 109.6 Melting of agar culture media . 109.7 Preparation of Petri dishes 1010 Laboratory samples 1010.1 General 1010.2 Sampling the cosmetic product . 1010.3 Transport 1010.4 Receipt and storage 1110.5 Handling produc

36、ts and samples 1110.6 Conservation and destruction of products 1111 Operating practices 1111.1 Hygienic precautions during the testing 1111.2 Preparation of the initial suspension and of sample dilutions .1211.2.1 General. 1211.2.2 Water-miscible product 1211.2.3 Water-immiscible products . 1311.3 C

37、ounting methods . 1311.4 Detection methods 1312 Expression of results .1313 Neutralization of the antimicrobial properties of the product .13Annex A (informative) Basic identification techniques .14Annex B (informative) Basic techniques for counting and plating 19Annex C (informative) Preparation an

38、d calibration of inoculums .20Bibliography .21iv ISO 2017 All rights reserved ISO 21148:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carrie

39、d 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 in the work. IS

40、O 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 Directives, Part 1. In particular the different

41、 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 some of the elements of this document may

42、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 declarations received (see www .iso .org/ pate

43、nts).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 assessment, as well as information abou

44、t 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 cancels and replaces the first edition (ISO

45、 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, “validation of the methodology” was ch

46、anged 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, editorial changes were applied. ISO 2017

47、All rights reserved vBS EN ISO 21148:2017ISO 21148:2017(E)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 achieve homogeneous result

48、s 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 present in the sampl

49、es 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 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