EN ISO 18416-2015 en Cosmetics - Microbiology - Detection of Candida albicans《化妆品 微生物学 白色念珠菌的检测》.pdf

1、BSI Standards PublicationBS EN ISO 18416:2015Cosmetics Microbiology Detection of Candida albicansBS EN ISO 18416:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 18416:2015. It supersedes BS EN ISO 18416:2009 which iswithdrawn.The UK participation in its

2、 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 provisions of a contract. Users are responsible for its correct applica

3、tion. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 89373 5 ICS 07.100.99; 71.100.70 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Str

4、ategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18416 December 2015 ICS 07.100.99; 71.100.70 Supersedes EN ISO 18416:2009English Version Cosmetics - Microbiology - Detection of Cand

5、ida albicans (ISO 18416:2015) Cosmtiques - Microbiologie - Dtection de Candida albicans (ISO 18416:2015) Kosmetische Mittel - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2015) This European Standard was approved by CEN on 26 September 2015. CEN members are bound to comply with the CEN/C

6、ENELEC 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 standards may be obtained on application to the CEN-CENELEC Management Centr

7、e 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 notified to the CEN-CENELEC Management Centre has the same status as the

8、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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherla

9、nds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights

10、of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18416:2015 EBS EN ISO 18416:2015EN ISO 18416:2015 (E) 3 European foreword This document (EN ISO 18416:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with

11、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 endorsement, at the latest by juin 2016, and conflicting national standards shall be withdra

12、wn at the latest by juin 2016. Attention is drawn to the possibility 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 18416:2009. This docume

13、nt has been prepared under 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, Bu

14、lgaria, 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, Slovakia, Slovenia, Spain, Sweden, Switzerland,

15、Turkey and the United Kingdom. Endorsement notice The text of ISO 18416:2015 has been approved by CEN as EN ISO 18416:2015 without any modification. BS EN ISO 18416:2015ISO 18416:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 25 Diluents and

16、 culture media . 25.1 General . 25.2 Diluent for the yeast suspension (tryptone sodium chloride solution) 35.2.1 General 35.2.2 Composition . 35.2.3 Preparation . 35.3 Culture media . 35.3.1 General 35.3.2 Agar medium for suitability test (see Clause 11) 35.3.3 Enrichment broth 45.3.4 Selective agar

17、 medium for isolation of Candida albicans 45.3.5 Corn meal agar with 1 % polysorbate 80 . 56 Apparatus and glassware 57 Strains of microorganisms . 58 Handling of cosmetic products and laboratory samples 69 Procedure. 69.1 General recommendation 69.2 Preparation of the initial suspension in the enri

18、chment broth 69.2.1 General 69.2.2 Water-miscible products. 69.2.3 Water-immiscible products 69.2.4 Filterable products . 69.3 Incubation of the inoculated enrichment broth . 79.4 Detection and identification of Candida albicans 79.4.1 Isolation . 79.4.2 Identification of Candida albicans . 710 Expr

19、ession of the results (detection of Candida albicans) 811 Neutralization of the antimicrobial properties of the product 811.1 General . 811.2 Preparation of inoculum . 811.3 Suitability of the detection method . 811.3.1 Procedure . 811.3.2 Interpretation of suitability test results 912 Test report .

20、 9Annex A (informative) Other media .10Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 14Bibliography .15 ISO 2015 All rights reserved iiiContents PageBS EN ISO 18416:2015ISO 18416:2015(E)ForewordISO (the International Organization for Standardizatio

21、n) 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 technical committee has been established has the right to be rep

22、resented 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 matters of electrotechnical standardization.The procedures used to dev

23、elop 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 document was drafted in accordance with the editorial rules of the IS

24、O/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 such patent rights. Details of any patent rights identified during

25、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 and does not constitute an endorsement.For an explanation on the meaning

26、 of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Co

27、smetics.This second edition cancels and replaces the first edition (ISO 18416:2007), of which it constitutes a minor revision.iv ISO 2015 All rights reservedBS EN ISO 18416:2015ISO 18416:2015(E)IntroductionMicrobiological examinations of cosmetic products are carried out according to an appropriate

28、microbiological risk analysis in order to ensure their quality and safety for consumers.Microbiological risk analysis depends on several parameters such as the following: potential alteration of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, sk

29、in, eyes, mucous membranes); type of users (adults, children 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 infections. The detectio

30、n of other kinds of microorganism might be of interest since these microorganisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during the manufacturing process. ISO 2015 All rights reserved vBS EN ISO 18416:2015BS EN ISO 18416:2015Cosmetics Microbiolo

31、gy Detection of Candida albicans1 ScopeThis International Standard gives general guidelines for the detection and identification of the specified microorganism Candida albicans in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to co

32、untry according to national practices or regulations.In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic product to which this International Standard is applicable. Products considered

33、 to present a low microbiological (see ISO 29621) risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.The method described in this International Standard is based on the detection of Candida albicans in a non-selective liquid medium (enrichment broth), follow

34、ed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required.NOTE For the detection of Candida albicans, subcultures can be performed on non-selective culture media followed by suitable identification steps (e.g. using identification kits)

35、.Because of the large variety of cosmetic products within this field of application, this method may not be appropriate in every detail for some products (e.g. certain water immiscible products). Other International Standards (ISO 18415) may be appropriate. Other methods (e.g. automated) may be subs

36、tituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application.

37、For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 21148:2005, Cosmetics Microbiology General instructions for microbiological examinationEN 12353, Chemical disinfectants and antiseptics P

38、reservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1productpor

39、tion of an identified cosmetic product received in the laboratory for testing3.2sampleportion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspension3.3initial suspensionsuspension (or solution) of the sample in a defined volume of an appropriate enrichment b

40、rothINTERNATIONAL STANDARD ISO 18416:2015(E) ISO 2015 All rights reserved 1BS EN ISO 18416:2015ISO 18416:2015(E)3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and is recognized as a skin pa

41、thogen species that may be harmful for human health or as an indication of hygienic failure in the manufacturing process3.6Candida albicansyeast that form white to beige, creamy and convex colonies on the surface of a selective mediumNote 1 to entry: The main characteristic for identification is the

42、 production of germ tube and/or pseudomycelium and chlamydospore when the test is performed following the method specified in this International Standard.3.7enrichment brothnon-selective liquid medium containing suitable neutralizers and/or dispersing agents and demonstrated to be suitable for the p

43、roduct under test4 PrincipleThe first step of the procedure is to perform an enrichment by using a non-selective broth medium to increase the number of microorganisms without the risk of inhibition by the selective ingredients that are present in selective/differential growth media.The second step o

44、f the test (isolation) of the test is performed on a selective medium followed by identification tests.The possible inhibition of microbial growth by the sample shall be neutralized to allow the detection of viable microorganisms.1In all cases and whatever the methodology, the neutralization of the

45、antimicrobial properties of the product shall be checked and demonstrated (see Clause 11).5 Diluents and culture media5.1 GeneralGeneral instructions are given in ISO 21148. When water is mentioned in this International Standard, use distilled water or purified water as specified in ISO 21148.The en

46、richment broth is used to disperse the sample and to increase the initial microbial population. It may contain neutralizers if the specimen to be tested has antimicrobial properties. The efficacy of the neutralization shall be demonstrated (see Clause 11). Information relative to suitable neutralize

47、rs is given in Annex B.The enrichment broth (5.3.3.1), or any of the ones listed in Annex A, is suitable for checking the presence of Candida albicans in accordance with this International Standard provided that it has been demonstrated to be suitable in accordance with Clause 11.Other diluents and

48、culture media may be used if it has been demonstrated that they are suitable for use.2 ISO 2015 All rights reservedBS EN ISO 18416:2015ISO 18416:2015(E)5.2 Diluent for the yeast suspension (tryptone sodium chloride solution)5.2.1 GeneralThe diluent is used for the preparation of yeast suspension use

49、d for the suitability test procedure (see Clause 11).5.2.2 Composition tryptone, pancreatic digest of casein 1,0 g sodium chloride 8,5 g water 1 000 ml5.2.3 PreparationDissolve the components in water by mixing while heating. Dispense into suitable containers. Sterilize in the autoclave at 121 C for 15 min.After sterilization and cooling of the solution, the pH shall be equivalent to 7,0 0,2 when measured at room temperature.5.3 Culture media5.3.1 GeneralCulture media may be prepared using the descriptions provided below or from dehydrate