EN ISO 18416-2009 3125 Cosmetics - Microbiology - Detection of Candida albicans《化妆品 微生物学 白色念珠菌的测定》.pdf

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1、BRITISH STANDARDCosmetics Microbiology Detection of Candida albicansICS 07.100.99; 71.100.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g5818416:20

2、09BS EN ISOCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN ISO 18416:2009. It is identical to ISO 18416:2007

3、. It supersedes BS ISO 18416:2007 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CW/217, Cosmetics.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

4、 necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 18416:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 Se

5、ptember 2007 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 January 2010 This corrigendum renumbers BS ISO 18416:2007 as BS EN ISO 18416:2009ISBN 978 0 580 66830 2Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduct

6、ion or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 18416June 2009ICS 07.100.99; 71.100.70English VersionCosmetics - Microbiology - Detection of Candida albicans (ISO18416:2007)Cosmtiques - Microbiologie - Dtection de Candidaalbicans (ISO 18

7、416:2007)Kosmetik - Mikrobiologie - Nachweis von Candida albicans(ISO 18416:2007)This European Standard was approved by CEN on 23 May 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a nationa

8、l standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any o

9、ther language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia,

10、 Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES K

11、OMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 18416:2009: ECopyright European Committee for Standardization Provided by IHS under license with CENNot fo

12、r ResaleNo reproduction or networking permitted without license from IHS-,-,-Foreword The text of ISO 18416:2007 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 18416:2009 by Technical Commi

13、ttee CEN/SS H99 “Products for household and leisure use - Undetermined” the secretariat of which is held by CMC. 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 2009, and conflicting nati

14、onal standards shall be withdrawn at the latest by December 2009. 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. According to the CEN

15、/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

16、uxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18416:2007 has been approved by CEN as a EN ISO 18416:2009 without any modification. ii BS EN ISO 18416:2009Copyright European C

17、ommittee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-iiiContents Page Introduction . iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 Principle. 2 5 Diluents and culture media 2 5.1

18、 General. 2 5.2 Diluent for the yeast suspension (tryptone sodium chloride solution) 3 5.3 Culture media 3 6 Apparatus and glassware 5 7 Strains of microorganisms 5 8 Handling of cosmetic products and laboratory samples . 6 9 Procedure 6 9.1 General recommendation 6 9.2 Preparation of the initial su

19、spension in the enrichment broth 6 9.3 Incubation of the inoculated enrichment broth . 7 9.4 Detection and identification of Candida albicans . 7 10 Expression of the results (detection of Candida albicans) 8 11 Neutralization of the antimicrobial properties of the product 8 11.1 General. 8 11.2 Pre

20、paration of inoculum 8 11.3 Validation of the detection method. 9 12 Test report . 9 Annex A (informative) Other media 11 Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 15 Bibliography . 16 BS EN ISO 18416:2009Copyright European Committee for Stan

21、dardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ivIntroduction Microbiological examinations of cosmetic products are carried out according to an appropriate microbiological risk analysis in order to ensure their qua

22、lity and safety for consumers. Microbiological risk analysis 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

23、under 3 years). For cosmetics and other topical products, the detection of 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 those microorganisms (

24、including indicators of faecal contamination, e.g. Escherichia coli) suggest hygienic failure during the manufacturing process. BS EN ISO 18416:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without lic

25、ense from IHS-,-,-1Cosmetics Microbiology Detection of Candida albicans 1 Scope This 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

26、 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 so as to determine the types of cosmetic product to which this Internati

27、onal Standard is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, those with extreme pH values, etc. The method described in this International Standard is based on the detection of Candida albicans in a non-select

28、ive 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 Candida albicans, subcultures can be performed on non-selective culture media followed by suitable identifi

29、cation steps (e.g. using identification kits). Because of the large variety of cosmetic products within this field of application, this method might not be suited in every detail to some products (e.g. certain water-immiscible products). Other International Standards (e.g. ISO 18415) might be approp

30、riate. Other methods (e.g. automated) can be substituted for the test presented here provided that their equivalence has been demonstrated or the method has been otherwise validated. 2 Normative references The following referenced documents are indispensable for the application of this document. For

31、 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 examination EN 12353, Chemical disinfectants and antiseptics Pr

32、eservation of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 product portion of an identified cosmetic product received in the la

33、boratory for testing 3.2 sample portion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspension BS EN ISO 18416:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted wi

34、thout license from IHS-,-,-2 3.3 initial suspension suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth 3.4 sample dilution dilution of the initial suspension 3.5 specified microorganisms aerobic mesophilic bacteria or yeast that is undesirable in a cosmetic

35、 product because it can cause skin or eye infections or is an indication of hygienic failure 3.6 Candida albicans yeast that form white to beige, creamy and convex colonies on the surface of a selective medium NOTE The main characteristic for identification is the production of germ tube and/or pseu

36、domycelium and chlamydospore when the test is performed following the method specified in this International Standard. 3.7 enrichment broth non-selective liquid medium containing suitable neutralizers and/or dispersing agents and validated for the product under test 4 Principle The first step of the

37、 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 (isolation) of the test is performed on a selecti

38、ve medium followed by identification tests. To prevent the possible inhibition of microbial growth by the sample it shall be neutralized to allow the detection of viable microorganisms 1. In all cases and whatever the methodology, the neutralization of the antimicrobial properties of the product sha

39、ll be checked and validated 2, 3, 4. 5 Diluents and culture media 5.1 General General 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 and

40、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 (5.3.

41、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 is validated in accordance with Clause 11. Other diluents and culture media may be used if it has been demonstrated that they are suit

42、able for use. BS EN ISO 18416:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-35.2 Diluent for the yeast suspension (tryptone sodium chloride solution) 5.2.1 General The dilu

43、ent is used for the preparation of yeast suspension used for the validation procedure (see Clause 11). 5.2.2 Composition tryptone, pancreatic digest of casein 1,0 g sodium chloride 8,5 g water 1 000 ml 5.2.3 Preparation Dissolve the components in water by mixing whilst heating. Dispense into suitabl

44、e 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 media 5.3.1 General Culture media may be prepared using the descriptions provided below or from dehydrat

45、ed culture media in accordance with the manufacturers instructions. The instructions provided by the supplier of the media should be followed. NOTE Ready-to-use media may be used when their composition and/or growth yields are comparable to those of the formulae given herein. 5.3.2 Agar medium for v

46、alidation 5.3.2.1 Sabouraud dextrose agar (SDA) 5.3.2.1.1 Composition dextrose 40,0 g peptic digest of animal tissue 5,0 g pancreatic digest of casein 5,0 g agar 15,0 g water 1 000 ml 5.3.2.1.2 Preparation Dissolve the components or the dehydrated complete medium in the water by heating. Dispense th

47、e medium into suitable containers. Sterilize in an autoclave at 121 C for 15 min. After sterilization the pH shall be equivalent to 5,6 0,2 when measured at room temperature. BS EN ISO 18416:2009Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo r

48、eproduction or networking permitted without license from IHS-,-,-4 5.3.2.2 Other agar media for validation Other agar media for validation may be used as appropriate (see Annex A). 5.3.3 Enrichment broth 5.3.3.1 Eugon LT 100 broth 5.3.3.1.1 General This medium contains ingredients which neutralize inhibitory substances present in the sample: lecithin and polysorbate 80, and dispersing agent octoxynol 9. 5.3.3.1.2 Composition pancreatic digest of casein 15,0 g papaic digest of soybean meal 5,0 g L-cystine 0,7 g sodium chloride 4,0 g sodium sulfite 0,2 g gl