EN ISO 22718-2015 en Cosmetics - Microbiology - Detection of Staphylococcus aureus《化妆品 微生物学 葡萄球菌的检测(ISO 22718 2015)》.pdf

1、BSI Standards PublicationBS EN ISO 22718:2015Cosmetics Microbiology Detection of StaphylococcusaureusBS EN ISO 22718:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 22718:2015. It supersedes BS EN ISO 22718:2009 which is withdrawn.The UK participation i

2、n 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 ap

3、plication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 89372 8 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 an

4、d Strategy Committee on 31 December 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 22718 December 2015 ICS 07.100.99; 71.100.70 Supersedes EN ISO 22718:2009English Version Cosmetics - Microbiology - Detection of Staphyloco

5、ccus aureus (ISO 22718:2015) Cosmtiques - Microbiologie - Dtection de Staphylococcus aureus (ISO 22718:2015) Kosmetische Mittel - Mikrobiologie - Nachweis von Staphylococcus aureus (ISO 22718:2015) This European Standard was approved by CEN on 26 September 2015. CEN members are bound to comply with

6、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-CENELEC Managem

7、ent 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 the same statu

8、s 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, Luxembourg, Malta,

9、 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 Brussels 2015 CEN Al

10、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 22718:2015 EBS EN ISO 22718:2015EN ISO 22718:2015 (E) 3 European foreword This document (EN ISO 22718:2015) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaborat

11、ion 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 standards shall b

12、e 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 supersedes EN ISO 22718:2009. Th

13、is document 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, Be

14、lgium, 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, Spain, Sweden, Swit

15、zerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22718:2015 has been approved by CEN as EN ISO 22718:2015 without any modification. BS EN ISO 22718:2015ISO 22718:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Principle 25 Dil

16、uents 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) soybean-casein digest agar

17、 medium (SCDA) or tryptic soy agar (TSA) . 35.3.3 Enrichment broth 45.3.4 Selective agar medium for isolation of Staphylococcus aureus 56 Apparatus and glassware 67 Strains of microorganisms . 68 Handling of cosmetic products and laboratory samples 69 Procedure. 79.1 General recommendation 79.2 Prep

18、aration of the initial suspension in the enrichment broth 79.2.1 General 79.2.2 Water-miscible products. 79.2.3 Water-immiscible products 79.2.4 Filterable products . 79.3 Incubation of the inoculated enrichment broth . 79.4 Detection and identification of Staphylococcus aureus 79.4.1 Isolation . 79

19、.4.2 Identification of Staphylococcus aureus . 810 Expression of the results (detection of Staphylococcus aureus) . 811 Neutralization of the antimicrobial properties of the product 911.1 General . 911.2 Preparation of inoculum . 911.3 Suitability of the detection method . 911.3.1 Procedure . 911.3.

20、2 Interpretation of suitability test results 912 Test report 10Annex A (informative) Other media .11Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids 14Bibliography .15 ISO 2015 All rights reserved iiiContents PageBS EN ISO 22718:2015ISO 22718:2015(E)F

21、orewordISO (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 tec

22、hnical 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 matters o

23、f 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 document

24、 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 such

25、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 and does

26、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 principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informati

27、onThe committee responsible for this document is ISO/TC 217, Cosmetics.This second edition cancels and replaces the first edition (ISO 22718:2006), of which it constitutes a minor revision.iv ISO 2015 All rights reservedBS EN ISO 22718:2015ISO 22718:2015(E)IntroductionMicrobiological examinations of

28、 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 several parameters such as the following: potential alteration of cosmetic products; pathogenicity of microo

29、rganisms; 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 of skin pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans may be relev

30、ant 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. Escherichia coli) suggest hygienic failure during the manufacturing process. ISO 2015 All rights reserve

31、d vBS EN ISO 22718:2015BS EN ISO 22718:2015Cosmetics Microbiology Detection of Staphylococcus aureus1 ScopeThis International Standard gives general guidelines for the detection and identification of the specified microorganism Staphylococcus aureus in cosmetic products. Microorganisms considered as

32、 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 advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic produc

33、t 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, extreme pH values, etc.The method described in this International Standard is based on the detection of Sta

34、phylococcus aureus in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required.NOTE For the detection of Staphylococcus aureus, subcultures can be performed on non-selective cultu

35、re 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 appropriate for some products in every detail (e.g. certain water immiscible products). Other International S

36、tandards (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 has been otherwise shown to be suitable.2 Normative referencesThe following documents, in whole or in part, are

37、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 referenced document (including any amendments) applies.ISO 21148:2005, Cosmetics Microbiology General instruction

38、s for microbiological examinationEN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity3 Terms and definitionsFor the

39、 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 product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspensionINTERNATIONAL STANDARD ISO

40、22718:2015(E) ISO 2015 All rights reserved 1BS EN ISO 22718:2015ISO 22718:2015(E)3.3initial suspensionsuspension (or solution) of the sample in a defined volume of an appropriate enrichment broth3.4sample dilutiondilution of the initial suspension3.5specified microorganismaerobic mesophilic bacteriu

41、m 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 manufacturing process3.6Staphylococcus aureusgram-positive cocci, mainly aggregated in grape-like clusters, smooth col

42、onies generally pigmented in yellowNote 1 to entry: The main characteristics for identification are: growth on specific selective medium, catalase positive, coagulase positive.Note 2 to entry: Staphylococcus aureus is an opportunistic pathogen for humans that can also be present on the skin of healt

43、hy people without causing disorder for them. It is undesirable in cosmetic products due to its potential pathogenicity.3.7enrichment brothnon-selective liquid medium containing suitable neutralizers and/or dispersing agents and demonstrated to be suitable for the product under test4 PrincipleThe fir

44、st 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 the test (isolation) is performed

45、 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 microorganisms1. In all cases and whatever the methodology, the neutralization of the antimicrobial properties of the product shall

46、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 is used to disperse the sample

47、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 Annex B.The enrichment broth (5

48、.3.3.1), or any of the ones listed in Annex A, is suitable for checking the presence of Staphylococcus aureus 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 22718:2015ISO 22718:

49、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 used for the preparation of bacterial suspension used 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