EN ISO 16212-2017 en Cosmetics - Microbiology - Enumeration of yeast and mould.pdf

1、Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017) BS EN ISO 16212:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16212 July 2017 ICS 07.100.40 Supersedes EN ISO 16212:2011English V

2、ersion Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017) Cosmtiques - Microbiologie - Dnombrement des levures et des moisissures (ISO 16212:2017) Kosmetische Mittel - Mikrobiologie - Zhlung von Hefen und Schimmelpilzen (ISO 16212:2017) This European Standard was approved by

3、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-date lists and bibliographical references concerning such national standard

4、s 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 responsibility of a CEN member into its own language and notif

5、ied 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 Republic of Macedonia, France, Germany, Greece, Hungary, Ice

6、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, 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-CENE

7、LEC 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 16212:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 16212:2017. It supersedes BS EN

8、 ISO 16212:2011, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisio

9、ns of a contract. Users are responsible for its correct application. The British Standards Institution 2017Published by BSI Standards Limited 2017ISBN 978 0 580 95717 8ICS 07.100.40Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published un

10、der the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 16212:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16212 July 2017 ICS 07.100.40 Supersedes EN ISO 16212:2011En

11、glish Version Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2017) Cosmtiques - Microbiologie - Dnombrement des levures et des moisissures (ISO 16212:2017) Kosmetische Mittel - Mikrobiologie - Zhlung von Hefen und Schimmelpilzen (ISO 16212:2017) This European Standard was appro

12、ved 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-date lists and bibliographical references concerning such national s

13、tandards 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 responsibility of a CEN member into its own language an

14、d 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 Republic of Macedonia, France, Germany, Greece, Hunga

15、ry, 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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG C

16、EN-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 16212:2017 EBS EN ISO 16212:2017EN ISO 16212:2017 (E) 3 European foreword This document (EN ISO 16212:2017) ha

17、s been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee 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 endorsem

18、ent, at the latest by January 2018 and conflicting national standards shall be withdrawn at the latest by January 2018. 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 s

19、uch patent rights. This document supersedes EN ISO 16212:2011. 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, Eston

20、ia, 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 United Kingdom. Endorsement noti

21、ce The text of ISO 16212:2017 has been approved by CEN as EN ISO 16212:2017 without any modification. ISO 16212:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Principles . 24.1 General . 24.2 Plate count 24.3 Membrane filtration . 25 Diluents, neutralizers and cult

22、ure media . 35.1 General . 35.2 Neutralizing diluents and diluents 35.3 Diluent for yeast suspension (tryptone sodium chloride solution) 45.4 Culture media . 46 Apparatus and glassware 57 Strain of microorganisms 58 Handling of cosmetic products and laboratory samples 69 Procedure. 69.1 General reco

23、mmendation 69.2 Preparation of the initial suspension 69.2.1 General 69.2.2 Water-miscible products. 69.2.3 Water-immiscible products 69.3 Counting methods 69.3.1 Dilutions for counting methods 69.3.2 Plate-count methods 710 Counting of colonies (plate counts and membrane filtration methods) 711 Exp

24、ression of results 811.1 Method of calculation for plate count . 811.2 Interpretation 912 Neutralization of the antifungicidal properties of the product 1012.1 General 1012.2 Preparation of inoculum 1112.3 Suitability of counting methods 1112.3.1 Principle . 1112.3.2 Suitability test of the pour-pla

25、te method 1112.3.3 Suitability of the surface spread method .1112.3.4 Suitability of the membrane filtration method .1113 Test report 12Annex A (informative) Other neutralizing diluents .13Annex B (informative) Other diluents 15Annex C (informative) Other culture media .16Annex D (informative) Neutr

26、alizers of antifungicidal activity of preservatives and rinsing liquids 18Bibliography .19 ISO 2017 All rights reserved iiiContents PageBS EN ISO 16212:2017ISO 16212:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Principles . 24.1 General . 24.2 Plate count 24.3 Me

27、mbrane filtration . 25 Diluents, neutralizers and culture media . 35.1 General . 35.2 Neutralizing diluents and diluents 35.3 Diluent for yeast suspension (tryptone sodium chloride solution) 45.4 Culture media . 46 Apparatus and glassware 57 Strain of microorganisms 58 Handling of cosmetic products

28、and laboratory samples 69 Procedure. 69.1 General recommendation 69.2 Preparation of the initial suspension 69.2.1 General 69.2.2 Water-miscible products. 69.2.3 Water-immiscible products 69.3 Counting methods 69.3.1 Dilutions for counting methods 69.3.2 Plate-count methods 710 Counting of colonies

29、(plate counts and membrane filtration methods) 711 Expression of results 811.1 Method of calculation for plate count . 811.2 Interpretation 912 Neutralization of the antifungicidal properties of the product 1012.1 General 1012.2 Preparation of inoculum 1112.3 Suitability of counting methods 1112.3.1

30、 Principle . 1112.3.2 Suitability test of the pour-plate method 1112.3.3 Suitability of the surface spread method .1112.3.4 Suitability of the membrane filtration method .1113 Test report 12Annex A (informative) Other neutralizing diluents .13Annex B (informative) Other diluents 15Annex C (informati

31、ve) Other culture media .16Annex D (informative) Neutralizers of antifungicidal activity of preservatives and rinsing liquids 18Bibliography .19 ISO 2017 All rights reserved iiiContents PageBS EN ISO 16212:2017ISO 16212:2017(E)ForewordISO (the International Organization for Standardization) is a wor

32、ldwide 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 technical committee has been established has the right to be represented on

33、 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 matters of electrotechnical standardization. The procedures used to develop this

34、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 document was drafted in accordance with the editorial rules of the ISO/IEC Dire

35、ctives, 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 such patent rights. Details of any patent rights identified during the dev

36、elopment 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 and does not constitute an endorsement. For an explanation on the voluntary

37、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 to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.Thi

38、s document was prepared by Technical Committee ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 16212:2008), of which it constitutes a minor revision. The changes compared to the previous edition are as follows: in the Scope, “see ISO 29621” has been added and th

39、e 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 4.1, “validated” has been changed to “demonstrated”; in 4.3, “by a valid method” has been changed to “as described in Clause 12” and “

40、validated procedure” has been replaced by “described procedure”; in 5.1, “specifications” has been changed to “instructions”; in 5.2.3.1.2, “peptone” has been changed to “peptic digest of animal tissue”; in Clause 7, “validation” has been changed to “suitability”; in 9.3.2.1, “validated” has been ch

41、anged to “demonstrated to be suitable”; in 9.3.2.3, “prepared as validated” has been changed to “demonstrated to be suitable”; in 11.2.1, “validated according to” has been changed to “demonstrated to be suitable for”; in 12.3, “validation” has been changed to “suitability”; in 12.3.2, instances of “

42、validation” have been changed to “suitability test” and “validated” has been changed to “satisfactory”; in 12.3.3, the first instance of “validation” has been changed to “suitability” and the second instance has been changed to “suitability test”; “validated” has been changed to “satisfactory”;iv IS

43、O 2017 All rights reservedBS EN ISO 16212:2017ISO 16212:2017(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 carried out through ISO technical comm

44、ittees. 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. ISO collaborates closely with the

45、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 approval criteria needed for th

46、e 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 be the subject of patent rights.

47、 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/ patents).Any trade name used in this

48、 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 about ISOs adherence to the World Tr

49、ade 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 16212:2008), of which it constitutes a minor revision. The changes compared to the previous edition are as follows: in the Scope, “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 “vali