EN ISO 18415-2011 en Cosmetics - Microbiology - Detection of specified and non-specified microorganisms《化妆品 微生物学 专用和非专用微生物的探测》.pdf

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1、BRITISH STANDARDBS EN ISO 18415:2011Cosmetics Microbiology Detection of specified and non-specified microorganismsICS 07.100.99; 71.100.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3

2、g38g50g51g60g53g44g42g43g55g3g47g36g58Incorporating corrigendumJune 2011National forewordThis British Standard is the UK implementation of EN ISO 18415:2011. It is identical with ISO 18415:2007. It supersedes BS ISO 18415:2007, which is withdrawn.The UK participation in its preparation was entrusted

3、 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 application.Compliance with a Bri

4、tish Standard cannot confer immunity from legal obligations.BS EN ISO 18415:2011This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 September 2007 BSI 2011Amendments/corrigenda issued since publicationDate Comments 31 July 2011 This corrigendu

5、m renumbers BS ISO 18415:2008 as BS EN ISO 18415:2011ISBN 978 0 580 72864 8EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18415 June 2011 ICS 07.100.99; 71.100.70 English Version Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2007) Cosmtiques

6、- Microbiologie - Dtection des micro-organismes spcifis et non spcifis (ISO 18415:2007) Kosmetik - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO 18415:2007) This European Standard was approved by CEN on 12 May 2011. CEN members are bound to comply with the

7、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 Management

8、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 status as

9、 the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

10、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved

11、 worldwide for CEN national Members. Ref. No. EN ISO 18415:2011: E3 Foreword The text of ISO 18415:2007 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 18415:2011 by Technical Committee CEN/

12、TC 392 “Cosmetics” the secretariat of which is held by NEN. 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 2011, and conflicting national standards shall be withdrawn at the latest by De

13、cember 2011. 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, the national standards

14、 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

15、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 18415:2007 has been approved by CEN as a EN ISO 18415:2011 without any modification. BS EN ISO 18415:2011EN ISO 18415:2011 (E)iiiContents Page Foreword iv Introduction v 1

16、Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Principle. 3 5 Diluents and culture media 3 5.1 General. 3 5.2 Diluent for the microbial suspension (tryptone sodium chloride solution) . 3 5.3 Culture media 4 6 Apparatus and glassware 5 7 Strains of microorganism 5 8 Handling of cos

17、metic products and laboratory samples . 6 9 Procedure 6 9.1 General recommendations 6 9.2 Preparation of the initial suspension in the enrichment broth 6 9.3 Incubation of the initial suspension . 7 9.4 Isolation of specified and non-specified microorganisms. 7 9.5 Procedure for identification of th

18、e specified microorganism: Pseudomonas aeruginosa. 7 9.6 Procedure for identification of the specified microorganism: Escherichia coli 8 9.7 Procedure for identification of the specified microorganism: Staphylococus aureus . 8 9.8 Procedure for the identification of the specified microorganism: Cand

19、ida albicans 9 9.9 Procedure for the identification of non-specified microorganisms 9 10 Expression of the results. 10 10.1 Detection of specified microorganisms .10 10.2 Detection of non-specified microorganisms . 10 10.3 Absence of microorganisms . 10 11 Neutralization of the antimicrobial propert

20、ies of the product 10 11.1 General. 10 11.2 Preparation of inoculum 10 11.3 Validation of detection method by enrichment . 11 12 Test report . 12 Annex A (informative) General scheme for identification of microorganisms 13 Annex B (informative) Other Media 14 Annex C (informative) Neutralizers of an

21、timicrobial activity of preservatives and rinsing liquids . 17 Bibliography . 18 BS EN ISO 18415:2011EN ISO 18415:2011 (E)iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internation

22、al Standards is normally 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,

23、 also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical comm

24、ittees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the p

25、ossibility 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 patent rights. ISO 18415 was prepared by Technical Committee ISO/TC 217, Cosmetics. BS EN ISO 18415:2011EN ISO 18415:2011 (E)vIntroduction Micr

26、obiological 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 several parameters such as: potential alteration of cosmetic products; pathogeni

27、city of microorganisms; site of application of the cosmetic product (hair, skin, eyes, mucous membranes); type of user (adults, children, including under 3 years). For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus, Pseudomonas aeruginosa and Cand

28、ida albicans may be relevant because they can cause skin or eye infection. The detection of other kinds of microorganisms might be of interest since these microorganisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during manufacturing process. BS EN

29、ISO 18415:2011EN ISO 18415:2011 (E)blank1Cosmetics Microbiology Detection of specified and non-specified microorganisms 1 Scope This International Standard gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and

30、identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations. Most of them considered as specified micro

31、organisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis in order to determine the

32、 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 this International Standard is based on the detect

33、ion of microbial growth in a non-selective liquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation of microorganisms on non-selective agar media. Other methods can be appropriate depending on the level of detection required. In this International Standard s

34、pecific indications are given for identification of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under the conditions described in this International Standard, may be identified by using suitable tests according to a general sch

35、eme (see Annex A). Other standards (e.g., ISO 18416, ISO 21150, ISO 22717, ISO 22718) may be appropriate. 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). Ot

36、her 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 dated re

37、ferences, 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 Preservatio

38、n of test organisms used for the determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity BS EN ISO 18415:2011EN ISO 18415:2011 (E)2 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 product portion of an identified c

39、osmetic 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 3.3 initial suspension suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth 3.4 sample d

40、ilution dilution of the initial suspension 3.5 aerobic mesophilic microorganisms mesophilic bacteria or yeast growing aerobically under the conditions specified in this International Standard NOTE In the described conditions other types of microorganism (e.g. molds) are detectable. 3.6 specified mic

41、roorganisms aerobic mesophilic bacteria or yeast undesirable in a cosmetic product and recognised as a skin pathogen species that may be harmful for human health or as an indication of hygienic failure in the manufacturing process 3.6.1 Pseudomonas aeruginosa Gram-negative rod (bacilli), motile; smo

42、oth colonies pigmented (pigmented brown or greenish) NOTE 1 The main characteristics for identification are growth on a selective cetrimide agar medium, oxidase positive, production of diffusible fluorescent pigments and production of a soluble phenazine pigment (pyocyanin) in suitable media. NOTE 2

43、 Pseudomonas aeruginosa can be isolated from a wide variety of environmental sources, especially in water and has a very high potential to spoil many different substrates. It can produce infections of human skin or eye areas. It is undesirable in cosmetic products for its potential pathogenicity and

44、 its capacity to affect the physico-chemical properties of the cosmetic formula. 3.6.2 Escherichia coli Gram-negative rod (bacilli), motile, smooth colonies NOTE 1 The main characteristics are catalase positive, oxidase negative, fermentation of lactose, production of indole, growth on selective med

45、ium containing bile salts with characteristic colonies. NOTE 2 Escherichia coli can be isolated from the moist environmental sources (air, water, soil) and is a faecal contamination indicator. 3.6.3 Staphylococus aureus Gram-positive cocci, mainly aggregated in grape-like clusters, smooth colonies g

46、enerally pigmented in yellow NOTE 1 The main characteristics for identification are growth on a specific selective medium, catalase positive, coagulase positive. BS EN ISO 18415:2011EN ISO 18415:2011 (E)3NOTE 2 Staphylococcus aureus is an opportunistic pathogen for humans, which often can be also pr

47、esent on the skin of healthy individuals without causing them any apparent illness. It is a specified microorganism and undesirable in cosmetic products. 3.6.4 Candida albicans yeast that forms white to beige, creamy and convex colonies on the surface of a non-selective agar medium NOTE The main cha

48、racteristics for identification are production of germ tube and/or pseudomycelium and chlamydospore when the test is performed following the method specified in this International Standard 3.7 non-specified microorganism aerobic mesophilic bacteria or yeast found in cosmetic products, not defined in

49、 3.6 3.9 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 microorganisms without the risk of inhibition by the selective ingredients that are present in selective/differential growth media. The following steps (isolation and identification) are performed according to need by using appropriate conditions of incubation and suitabl