EN ISO 22717-2009 6250 Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa《化妆品 微生物学 绿脓杆菌的测定》.pdf

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1、BRITISH STANDARD22717:2009Cosmetics Microbiology Detection of Pseudomonas aeruginosaICS 07.100.99; 71.100.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g

2、47g36g58BS EN ISOProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN ISO 22717:2009. It is identical to ISO 22717:2006. It supersedes BS ISO 22717:2006 which is withdrawn.The UK partic

3、ipation 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

4、 correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 22717:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2006 BSI 2010Amendments/corrigenda issued since publicationDate

5、 Comments 31 August 2010 This corrigendum renumbers BS ISO 22717:2006 as BS EN ISO 22717:2009ISBN 978 0 580 66944 6Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22717June 2009ICS 07.100.99; 71.1

6、00.70English VersionCosmetics - Microbiology - Detection of Pseudomonasaeruginosa (ISO 22717:2006)Cosmtiques - Microbiologie - Recherche de Pseudomonasaeruginosa (ISO 22717:2006)Kosmetik - Mikrobiologie - Nachweis von Pseudomonasaeruginosa (ISO 22717:2006)This European Standard was approved by CEN o

7、n 30 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be o

8、btained 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 other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Manag

9、ement Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway

10、, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by

11、any means reservedworldwide for CEN national Members.Ref. No. EN ISO 22717:2009: EProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Foreword The text of ISO 22717:2006 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International

12、 Organization for Standardization (ISO) and has been taken over as EN ISO 22717:2009. 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 national standards shall be wit

13、hdrawn 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/CENELEC Internal Regulatio

14、ns, 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, Luxembourg, Malta, Netherlan

15、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 22717:2006 has been approved by CEN as a EN ISO 22717:2009 without any modification. BS EN ISO 22717:2009EN ISO 22717:2009 (E)iiProvided by IHSNot for Resa

16、leNo 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 General. 2 5.2 Diluent for the bacterial suspension (tryptone sodium chloride so

17、lution). 3 5.3 Culture media 3 6 Apparatus and glassware 5 7 Strains of micro-organisms . 6 8 Handling of cosmetic products and laboratory samples . 6 9 Procedure 6 9.1 General recommendation 6 9.2 Preparation of the initial suspension in the enrichment broth 6 9.3 Incubation of the inoculated enric

18、hment broth . 7 9.4 Detection and Identification of Pseudomonas aeruginosa 7 10 Expression of results . 8 11 Neutralization of the antimicrobial properties of the product 8 11.1 General. 8 11.2 Preparation of the inoculum 8 11.3 Validation of the detection method. 8 12 Test report . 9 Annex A (infor

19、mative) Other enrichment broths. 10 Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 12 Bibliography . 13 BS EN ISO 22717:2009EN ISO 22717:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-vInt

20、roduction Microbiological examinations of cosmetic products shall be 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: potential alteration of cosmetic

21、products; pathogenicity of micro-organisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes, etc.); type of users (adults, children under 3 years). For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus, Pseudomonas aer

22、uginosa and Candida albicans may be relevant. The detection of other kinds of micro-organism might be of interest since these micro-organisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during the manufacturing process. BS EN ISO 22717:2009EN ISO 227

23、17:2009 (E)iProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1Cosmetics Microbiology Detection of Pseudomonas aeruginosa 1 Scope This International Standard gives general guidelines for the detection and identification of the specified micro-organism

24、Pseudomonas aeruginosa in cosmetic products. Micro-organisms 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 advisable to perform an appropri

25、ate microbiological risk analysis to determine the types of cosmetic product to which this International Standard is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc. The method described in

26、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 required. NOTE For the detection of Pseudomonas

27、 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 appropriate in every detail for some product

28、s (e.g. certain water immiscible products). Other International Standards (ISO 18415 10) 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 validated. 2 Normative re

29、ferences The following referenced documents are indispensable for the application of this document. 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 G

30、eneral instructions for microbiological examination EN 12353, Chemical disinfectants and antiseptics Preservation of microbial strains used for the determination of bactericidal and fungicidal activity 3 Terms and definitions For the purposes of this document, the following terms and definitions app

31、ly. 3.1 product portion of an identified cosmetic product received in the laboratory 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 22717:2009EN ISO 22717:2009 (E)Provided by IHSNot for ResaleNo reproduction o

32、r networking permitted without 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(s) dilution(s) of the initial suspension 3.5 specified micro-organism aerobic mesophilic bacteria or yeast th

33、at is undesirable in a cosmetic product and is recognized as a skin pathogen species that may be harmful for human health or as indication of hygienic failure in the manufacturing process 3.6 Pseudomonas aeruginosa Gram-negative rod, motile; smooth colonies pigmented brown or greenish NOTE 1 The mai

34、n characteristics for identification are: growth on selective cetrimide agar medium, oxidase positive, production of diffusible fluorescent pigments and production of a soluble phenazine pigment (pyocyanin) in suitable media. NOTE 2 Pseudomonas aeruginosa may be isolated from a wide variety of envir

35、onmental 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 is undesirable in cosmetic products for its potential pathogenicity and its capacity to affect the physico-chemical properties of the cosmet

36、ic formula. 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 procedure is to perform an enrichment by using a non-selective broth medium to increase the number of micr

37、o-organisms 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 on a selective medium followed by identification tests. The possible inhibition of microbial growth by the sample shal

38、l be neutralized to allow the detection of viable micro-organisms 1. In all cases and whatever the methodology, the neutralization of the antimicrobial properties of the product shall be checked and validated 2, 3, 4. 5 Diluents and culture media 5.1 General General instructions are given in ISO 211

39、48. When water is mentioned in this document, use distilled water or purified water as specified in ISO 21148. The enrichment 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.

40、The efficacy of the neutralization shall be demonstrated (see Clause 11). Information relative to suitable neutralizers is given in Annex B. The following enrichment broth is suitable for checking the presence of Pseudomonas aeruginosa in accordance with this International Standard provided that it

41、is validated in accordance with Clause 11. Other diluents and culture media may be used if they can be demonstrated to be suitable for use. BS EN ISO 22717:2009EN ISO 22717:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-35.2 Diluent for the

42、bacterial suspension (tryptone sodium chloride solution) 5.2.1 General The diluent is used for the preparation of bacterial 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 Preparati

43、on Dissolve the components in water by mixing whilst heating. Dispense into suitable containers. Sterilize in the autoclave at 121 C for 15 min. After sterilization and cooling down, the pH shall be equivalent to 7,0 0,2 when measured at room temperature. 5.3 Culture media 5.3.1 General Culture medi

44、a may be prepared using the descriptions provided below or from dehydrated culture media according to the instructions of the manufacturer. 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 c

45、omparable to those of the formulas given herein. 5.3.2 Agar medium for validation (soybeancasein digest agar medium or tryptic soy agar) 5.3.2.1 Composition pancreatic digest of casein 15,0 g papaic digest of soybean meal 5,0 g sodium chloride 5,0 g agar 15,0 g water 1 000 ml 5.3.2.2 Preparation Dis

46、solve the components or the dehydrated complete medium in the water by mixing whilst heating. Dispense the medium into suitable containers. Sterilize in the autoclave at 121 C for 15 min. After sterilization and cooling down, the pH shall be equivalent to 7,3 0,2 when measured at room temperature. B

47、S EN ISO 22717:2009EN ISO 22717:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-4 5.3.3 Enrichment broth 5.3.3.1 Eugon LT 100 broth 5.3.3.1.1 General This medium contains ingredients that neutralize inhibitory substances present in the sample

48、: 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 glucose 5,5 g egg lecithin 1,0 g polysorbate 80 5,0 g octoxynol 9 1,0 g water 1 000 ml 5.3.3.1.3 Preparation Dissolve the components, one after another, in boiling water polysorbate 80, octoxynol 9 and egg lecithin until their complete dissolution. Dissolve the other components by mixing whilst heating. Dispense the medium in