EN ISO 22718-2009 4375 Cosmetics - Microbiology - Detection of Staphylococcus aureus《化妆品 微生物学 葡萄球菌的识别》.pdf

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1、BRITISH STANDARDBS ISO 22718:2009Cosmetics Microbiology Detection of Staphylococcus aureus ICS 07.100.99; 71.100.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g4

2、3g55g3g47g36g58ENProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-National forewordThis British Standard is the UK implementation of EN ISO 22718:2009. It is identical to ISO 22718:2006. It supersedes BS ISO 22718:2006 which is withdrawn.The UK partic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 22718:2009This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2010Amendments/corrigenda issued since publicationDate

5、 Comments 31 August 2010 This corrigendum renumbers BS ISO 22718:2006 as BS EN ISO 22718:2009ISBN 978 0 580 66945 3Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22718June 2009ICS 07.100.99; 71.1

6、00.70English VersionCosmetics - Microbiology - Detection of Staphylococcus aureus(ISO 22718:2006)Cosmtiques - Microbiologie - Dtection de Staphylococcusaureus (ISO 22718:2006)Kosmetik - Mikrobiologie - Nachweis von Staphylococcusaureus (ISO 22718:2006)This European Standard was approved by CEN on 30

7、 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 obtai

8、ned 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 Managemen

9、t 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, Po

10、land, 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 any

11、means reservedworldwide for CEN national Members.Ref. No. EN ISO 22718:2009: EProvided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-Foreword The text of ISO 22718:2006 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the International Org

12、anization for Standardization (ISO) and has been taken over as EN ISO 22718:2009. 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 withdra

13、wn 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 Regulations,

14、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, Netherlands,

15、Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 22718:2006 has been approved by CEN as a EN ISO 22718:2009 without any modification. iiBS EN ISO 22718:2009EN ISO 22718:2009 (E)Provided by IHSNot for ResaleNo

16、 reproduction or networking permitted without license from IHS-,-,-Contents Page Introduction . 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 solution).

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

18、 . 7 9.4 Detection and Identification of Staphylococcus aureus. 7 10 Expression of the results (detection of Staphylococcus aureus) . 8 11 Neutralization of the antimicrobial properties of the product 9 11.1 General. 9 11.2 Preparation of inoculum 9 11.3 Validation of the detection method. 9 12 Test

19、 report . 10 Annex A (informative) Other media 11 Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 14 Bibliography . 15 viiiiBS EN ISO 22718:2009EN ISO 22718:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without licens

20、e from IHS-,-,-Introduction 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 alter

21、ation of cosmetic 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 aureu

22、s, Pseudomonas aeruginosa 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 manufacturing process. viBS EN ISO 2271

23、8:2009EN ISO 22718:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-1Cosmetics Microbiology Detection of Staphylococcus aureus 1 Scope This International Standard gives general guidelines for the detection and identification of the specified m

24、icro-organism Staphylococcus aureus 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 perfor

25、m 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 risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc. The method

26、described in this International Standard is based on the detection of Staphylococcus 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

27、Staphylococcus aureus, 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 for some products in e

28、very detail (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 No

29、rmative references 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 Micr

30、obiology General 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 defin

31、itions apply. 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 22718:2009EN ISO 22718:2009 (E)Provided by IHSNot for ResaleNo repr

32、oduction or 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 o

33、r 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 indication of hygienic failure in the manufacturing process 3.6 Staphylococcus aureus Gram-positive cocci, mainly joined in grape-like clusters, smooth colonies g

34、enerally pigmented in yellow NOTE 1 The main characteristics for identification are: growth on specific selective medium, catalase positive, coagulase positive. NOTE 2 Staphylococcus aureus is an opportunistic pathogen bacterium for humans that can be also present on the skin of healthy people witho

35、ut causing disorder for them. It is undesirable in cosmetic products due to its potential pathogenicity. 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

36、to perform an enrichment by using a non-selective broth medium to increase the number of micro-organisms 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 selective medium fol

37、lowed by identification tests. The possible inhibition of microbial growth by the sample shall 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 validate

38、d 2, 3, 4. 5 Diluents and culture media 5.1 General General instructions are given in ISO 21148. 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 popula

39、tion. 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 following enrichment broth is suitable for checking the presen

40、ce of Staphylococcus aureus 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 they can be demonstrated to be suitable for use. BS EN ISO 22718:2009EN ISO 22718:2009 (E)Provided by IHSNot for Resa

41、leNo reproduction or networking permitted without license from IHS-,-,-35.2 Diluent for the 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 tryp

42、tone, 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 suitable containers. Sterilize in the autoclave at 121 C for 15 min. After sterilization and cooling down, the pH shall be equivalen

43、t to 7,0 r 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 dehydrated culture media according to the instructions from the manufacturer. The instructions provided by the supplier of the media should be

44、 followed. NOTE Ready to use media may be used when their composition and/or growth yields are comparable to those of the formulas given herein. 5.3.2 Agar medium for validation (see Clause 11) soybean-casein digest agar medium (SCDA) or tryptic soy agar (TSA) 5.3.2.1 Composition pancreatic digest o

45、f 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 Dissolve the components or the dehydrated complete medium in the water by mixing while heating. Dispense the medium into suitable containers. Sterilize in the autoclave at 121 C f

46、or 15 min. After sterilization and cooling down, the pH shall be equivalent to 7,3 r 0,2 when measured at room temperature. BS EN ISO 22718:2009EN ISO 22718:2009 (E)Provided by IHSNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-4 5.3.3 Enrichment broth 5.3.3.1 Eugo

47、n 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

48、 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 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 r 0,2