BS EN ISO 22717-2015 Cosmetics Microbiology Detection of Pseudomonas aeruginosa《化妆品 微生物学 绿脓杆菌的测定》.pdf

1、BSI Standards PublicationBS EN ISO 22717:2015Cosmetics Microbiology Detection of PseudomonasaeruginosaBS EN ISO 22717:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 22717:2015. It supersedes BS EN ISO 22717:2009 which is withdrawn.The UK participation

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

3、pplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 89371 1 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 a

4、nd Strategy 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 22717 December 2015 ICS 07.100.99; 71.100.70 Supersedes EN ISO 22717:2009English Version Cosmetics - Microbiology - Detection o

5、f Pseudomonas aeruginosa (ISO 22717:2015) Cosmtiques - Microbiologie - Dtection de Pseudomonas aeruginosa (ISO 22717:2015) Kosmetische Mittel - Mikrobiologie - Nachweis von Pseudomonas aeruginosa (ISO 22717:2015) This European Standard was approved by CEN on 26 September 2015. CEN members are bound

6、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 standards may be obtained on application to the CEN-

7、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 notified to the CEN-CENELEC Management Centre has

8、 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, Iceland, Ireland, Italy, Latvia, Lithuania, Lux

9、embourg, Malta, Netherlands, 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 Bruss

10、els 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22717:2015 EBS EN ISO 22717:2015EN ISO 22717:2015 (E) 3 European foreword This document (EN ISO 22717:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics

11、“ 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 endorsement, at the latest by June 2016, and conflicting national st

12、andards shall be withdrawn at the latest by June 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 has been prepared

13、 under a mandate given to CEN by the European Commission and the European Free Trade Association. This document supersedes EN ISO 22717:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standa

14、rd: 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, Romania, Slovakia, Slovenia, Spai

15、n, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22717:2015 has been approved by CEN as EN ISO 22717:2015 without any modification. BS EN ISO 22717:2015ISO 22717:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 P

16、rinciple 25 Diluents and culture media . 25.1 General . 25.2 Diluent for the bacterial 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 the suitability test (see Clause 11) soybeancase

17、in digest agar medium (SCDA) or tryptic soy agar (TSA) . 35.3.3 Enrichment broth 45.3.4 Selective agar medium for isolation of Pseudomonas aeruginosa . 55.3.5 Selective agar medium for confirmation of Pseudomonas aeruginosa 56 Apparatus and glassware 67 Strains of microorganisms . 68 Handling of cos

18、metic products and laboratory samples 69 Procedure. 69.1 General recommendation 69.2 Preparation of the initial suspension in the enrichment 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 inoculated enrichment

19、 broth . 79.4 Detection and Identification of Pseudomonas aeruginosa . 79.4.1 Isolation . 79.4.2 Identification of Pseudomonas aeruginosa 710 Expression of results (detection of Pseudomonas aeruginosa) . 811 Neutralization of the antimicrobial properties of the product 811.1 General . 811.2 Preparat

20、ion of the inoculum . 811.3 Suitability of the detection method . 811.3.1 Procedure . 811.3.2 Interpretation of suitability test results 912 Test report . 9Annex A (informative) Other enrichment broths .10Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liqui

21、ds 12Bibliography .13 ISO 2015 All rights reserved iiiContents PageBS EN ISO 22717:2015ISO 22717:2015(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 normal

22、ly 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 with ISO, also take part in the

23、 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 Directives, Part 1. In particular the d

24、ifferent 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 documen

25、t 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 declarations received (see www.iso.org/p

26、atents). 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 of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO prin

27、ciples in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 22717:2006), of which it constitutes a minor revision.iv ISO

28、 2015 All rights reservedBS EN ISO 22717:2015ISO 22717:2015(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 analysis depends on sev

29、eral parameters such as the following: potential alteration of cosmetic products; pathogenicity of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of users (adults, children under 3 years).For cosmetics and other topical products, the detection

30、of skin pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans may be relevant because they can cause skin or eye infections. The detection of other kinds of microorganism might be of interest since these microorganisms (including indicators of faecal contamination e.g.

31、 Escherichia coli) suggest hygienic failure during the manufacturing process. ISO 2015 All rights reserved vBS EN ISO 22717:2015BS EN ISO 22717:2015Cosmetics Microbiology Detection of Pseudomonas aeruginosa1 ScopeThis International Standard gives general guidelines for the detection and identificati

32、on of the specified microorganism Pseudomonas aeruginosa in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations.In order to ensure product quality and safety for consumers, it is

33、advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological (see ISO 29621) risk include those with low water activity, hydro-alcoholic products,

34、extreme pH values, etc.The method described in this International Standard is based on the detection of Pseudomonas aeruginosa in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection

35、required.NOTE For the detection of Pseudomonas aeruginosa, subcultures can be performed on non-selective culture media followed by suitable identification steps (e.g. using identification kits).Because of the large variety of cosmetic products within this field of application, this method may not be

36、 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 substituted for the tests presented here provided that their equivalence has been demonstrated or the method ha

37、s 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. For dated references, only the edition cited applies. For undated references, the latest edition of the ref

38、erenced document (including any amendments) applies.ISO 21148:2005, Cosmetics Microbiology General instructions for microbiological examinationEN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobacter

39、icidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1productportion of an identified cosmetic product received in the laboratory for testing3.2sampleportion of the produc

40、t (at least 1 g or 1 ml) that is used in the test to prepare the initial suspensionINTERNATIONAL STANDARD ISO 22717:2015(E) ISO 2015 All rights reserved 1BS EN ISO 22717:2015ISO 22717:2015(E)3.3initial suspensionsuspension (or solution) of the sample in a defined volume of an appropriate enrichment

41、broth3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacterium or yeast that is undesirable in a cosmetic product and is recognized as a skin pathogen species that may be harmful for human health or as an indication of hygienic failure in the manufact

42、uring process3.6Pseudomonas aeruginosagram-negative rod, motile; smooth colonies pigmented brown or greenishNote 1 to entry: The main characteristics for identification are: growth on selective cetrimide agar medium, oxidase positive, production of diffusible fluorescent pigments and production of a

43、 soluble phenazine pigment (pyocyanin) in suitable media.Note 2 to entry: Pseudomonas aeruginosa may be isolated from a wide variety of environmental sources, especially in water and has a very high potential to spoil many different substrates. It may produce infections of human skin or eye area. It

44、 is undesirable in cosmetic products for its potential pathogenicity and its capacity to affect the physico-chemical properties of the cosmetic formula.3.7enrichment brothnon-selective liquid medium containing suitable neutralizers and/or dispersing agents and demonstrated to be suitable for the pro

45、duct 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 of

46、the test (isolation) 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 antimicrobial

47、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 enrichment broth

48、 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 neutralizers is given in

49、 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 Pseudomonas aeruginosa in accordance with this International Standard provided that it has been demonstrated to be suitable in accordance with Clause 11.2 ISO 2015 All rights reservedBS EN ISO 22717:2015ISO 22717:2015(E)Other diluents and culture media may be used if it has been demonstrated that they are suitable for use.5.2 Diluent for the bacterial suspension (tryptone sodium chloride solution)5.2.1 GeneralThe diluent is