BS EN ISO 18415-2017 Cosmetics Microbiology Detection of specified and non-specified microorganisms《化妆品 微生物学 专用和非专用微生物的探测》.pdf

1、Cosmetics - Microbiology - Detection of specified and non-specified microorganismsBS EN ISO 18415:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18415 June 2017 ICS 07.100.40 Supersedes EN ISO 18415:2011En

2、glish Version Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017) Cosmtiques - Microbiologie - Dtection des micro-organismes spcifis et non spcifis (ISO 18415:2017)Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten

3、 Mikroorganismen (ISO 18415:2017) 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 alteration. Up-to-da

4、te 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 by translation

5、 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, Estonia, Finland, For

6、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 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATI

7、ON 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 18415:2017 ENational forewordThis British St

8、andard is the UK implementation of EN ISO 18415:2017. It is identical to ISO 18415:2017. It supersedes BS EN ISO 18415:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be

9、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 95714 7ICS 71.100.70; 07.100.4

10、0; 07.100.99Compliance 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 July 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN I

11、SO 18415:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18415 June 2017 ICS 07.100.40 Supersedes EN ISO 18415:2011English Version Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017) Cosmtiques - Microbiologie - Dtection des micro-organism

12、es spcifis et non spcifis (ISO 18415:2017)Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO 18415:2017) This European Standard was approved by CEN on 26 April 2017. CEN members are bound to comply with the CEN/CENELEC Internal Regulations w

13、hich 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. This

14、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 member

15、s 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, Portugal

16、, 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 in a

17、ny form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18415:2017 EBS EN ISO 18415:2017EN ISO 18415:2017 (E) 2 European foreword This document (EN ISO 18415:2017) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee

18、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 latest

19、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 18415:2011. According to the CEN-CENELEC Internal R

20、egulations, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland

21、, 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 ISO 18415:2017 has been approved by CEN as EN ISO 18415:2017 without any modification.

22、ISO 18415:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 35 Diluents and culture media . 35.1 General . 35.2 Diluent for the microbial suspension (tryptone sodium chloride solution) . 35.2.1 General 35.2.2 Composition . 45.2.3 Preparation .

23、45.3 Culture media . 45.3.1 General 45.3.2 Enrichment broth 45.3.3 Non-selective agar medium 56 Apparatus and glassware 57 Strains of microorganism 68 Handling of cosmetic products and laboratory samples 69 Procedure. 69.1 General recommendations 69.2 Preparation of the initial suspension in the enr

24、ichment broth 69.2.1 General 69.2.2 Water-miscible products. 79.2.3 Water-immiscible products 79.2.4 Filterable products . 79.3 Incubation of the initial suspension . 79.4 Isolation of specified and non-specified microorganisms . 79.5 Procedure for identification of the specified microorganism: Pseu

25、domonas aeruginosa . 79.5.1 Gram staining 79.5.2 Oxidase test 79.5.3 Identification test 89.6 Procedure for identification of the specified microorganism: Escherichia coli . 89.6.1 Gram staining 89.6.2 Oxidase test 89.6.3 Identification test 89.7 Procedure for identification of the specified microor

26、ganism: Staphylococcus aureus . 89.7.1 Gram staining 89.7.2 Catalase test . 89.7.3 Identification test 89.8 Procedure for the identification of the specified microorganism: Candida albicans . 99.8.1 Gram staining 99.8.2 Identification test 99.9 Procedure for the identification of non-specified micro

27、organisms 99.9.1 Gram staining 99.9.2 Oxidase test 99.9.3 Catalase test . 99.9.4 Identification test 910 Expression of the results .1010.1 Detection of specified microorganisms 10 ISO 2017 All rights reserved iiiContents PageBS EN ISO 18415:2017ISO 18415:2017(E)Foreword vIntroduction vi1 Scope . 12

28、Normative references 13 Terms and definitions . 14 Principle 35 Diluents and culture media . 35.1 General . 35.2 Diluent for the microbial suspension (tryptone sodium chloride solution) . 35.2.1 General 35.2.2 Composition . 45.2.3 Preparation . 45.3 Culture media . 45.3.1 General 45.3.2 Enrichment b

29、roth 45.3.3 Non-selective agar medium 56 Apparatus and glassware 57 Strains of microorganism 68 Handling of cosmetic products and laboratory samples 69 Procedure. 69.1 General recommendations 69.2 Preparation of the initial suspension in the enrichment broth 69.2.1 General 69.2.2 Water-miscible prod

30、ucts. 79.2.3 Water-immiscible products 79.2.4 Filterable products . 79.3 Incubation of the initial suspension . 79.4 Isolation of specified and non-specified microorganisms . 79.5 Procedure for identification of the specified microorganism: Pseudomonas aeruginosa . 79.5.1 Gram staining 79.5.2 Oxidas

31、e test 79.5.3 Identification test 89.6 Procedure for identification of the specified microorganism: Escherichia coli . 89.6.1 Gram staining 89.6.2 Oxidase test 89.6.3 Identification test 89.7 Procedure for identification of the specified microorganism: Staphylococcus aureus . 89.7.1 Gram staining 89

32、.7.2 Catalase test . 89.7.3 Identification test 89.8 Procedure for the identification of the specified microorganism: Candida albicans . 99.8.1 Gram staining 99.8.2 Identification test 99.9 Procedure for the identification of non-specified microorganisms 99.9.1 Gram staining 99.9.2 Oxidase test 99.9

33、.3 Catalase test . 99.9.4 Identification test 910 Expression of the results .1010.1 Detection of specified microorganisms 10 ISO 2017 All rights reserved iiiContents PageBS EN ISO 18415:2017ISO 18415:2017(E)10.2 Detection of non-specified microorganisms. 1010.3 Absence of microorganisms 1011 Neutral

34、ization of the antimicrobial properties of the product .1011.1 General 1011.2 Preparation of inoculum 1011.3 Suitability of detection method by enrichment .1011.3.1 Principle . 1011.3.2 Procedure 1111.3.3 Interpretation of suitability test results .1112 Test report 11Annex A (informative) General sc

35、heme for identification of microorganisms13Annex B (informative) Other media .14Annex C (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 17Bibliography .19iv ISO 2017 All rights reservedBS EN ISO 18415:2017ISO 18415:2017(E)10.2 Detection of non-specified micr

36、oorganisms. 1010.3 Absence of microorganisms 1011 Neutralization of the antimicrobial properties of the product .1011.1 General 1011.2 Preparation of inoculum 1011.3 Suitability of detection method by enrichment .1011.3.1 Principle . 1011.3.2 Procedure 1111.3.3 Interpretation of suitability test res

37、ults .1112 Test report 11Annex A (informative) General scheme for identification of microorganisms13Annex B (informative) Other media .14Annex C (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 17Bibliography .19iv ISO 2017 All rights reserved ISO 18415:2017(

38、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 carried out through ISO technical committees. Each member body interested in a subject for which a

39、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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matter

40、s 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 approval criteria needed for the different types of ISO documents should be noted. This docu

41、ment 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 be the subject of patent rights. ISO shall not be held responsible for identifying any or all

42、 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/ patents).Any trade name used in this document is information given for the convenience of users a

43、nd 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 about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers t

44、o 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 18415:2007), of which it constitutes a minor revision with the following changes: in the Sco

45、pe, “see ISO 29621” has been added and the reference has been added to the Bibliography; in the Scope, “used” has been changed to “substituted” and “validated” has been changed to “shown to be suitable”; in 3.8, the term “validated” has been changed to “demonstrated to be suitable”; in Clause 4, the

46、 term “validated” has been changed to “demonstrated”; in 5.1, “specifications” has been changed to “instructions”; in 5.1, the phrase “are validated” has been changed to “have been demonstrated to be suitable”; in 5.2.1, 5.3.3.1, 11.3.1, 11.3.2, instances of the term “validation” and in the heading

47、title of 11.3.3 have been changed to “suitability test”; in 11.3, the term “validation” in the heading title has been changed to “suitability”; in 11.3.3, instances of “validated” have been changed to “satisfactory”; in Clause 12 f), the term “validation” has been changed to “demonstration of the su

48、itability”. ISO 2017 All rights reserved vBS EN ISO 18415:2017ISO 18415:2017(E)IntroductionMicrobiological examinations of cosmetic products are carried out according to an appropriate microbiological risk analysis in order to ensure their quality and safety for consumers.Microbiological risk analys

49、is depends on several parameters such as: potential alteration of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of user (adults, children including under 3 years).For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans may be relevant because they can cause skin or eye infection. The detection of other kinds of microorganisms might be of interest si