SANS 18415-2009 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检测》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-22942-9 SANS 18415:2009Edition 1ISO 18415:2007Edition 1SOUTH AFRICAN NATIONAL STANDARD Cosmetics Microbiology Detection of specified and n

4、on-specified microorganisms This national standard is the identical implementation ISO 18415:2007 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428

5、7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 18415:2009 Edition 1 ISO 18415:2007 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 217, Cosmetics, in accordance with procedures of the SABS Standards Divisio

6、n, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2009. Reference numberISO 18415:2007(E)ISO 2007INTERNATIONAL STANDARD ISO18415First edition2007-09-01Corrected version2007-12-01Cosmetics Microbiology Detection of specified and non-specified microo

7、rganisms Cosmtiques Microbiologie Dtection des micro-organismes spcifis et non spcifis SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 18415:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance

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12、ase postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2007 All rights reservedSANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 1

13、8415:2007(E) ISO 2007 All rights reserved iiiContents Page Foreword iv Introduction v 1 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 Cu

14、lture media 4 6 Apparatus and glassware 5 7 Strains of microorganism 5 8 Handling of cosmetic 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

15、 of specified and non-specified microorganisms. 7 9.5 Procedure for identification of the 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: Staphyloco

16、cus aureus . 8 9.8 Procedure for the identification of the specified microorganism: Candida 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

17、 . 10 10.3 Absence of microorganisms . 10 11 Neutralization of the antimicrobial properties 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 microor

18、ganisms 13 Annex B (informative) Other Media 14 Annex C (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 17 Bibliography . 18 SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 18415:

19、2007(E) iv ISO 2007 All rights reservedForeword ISO (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 bod

20、y 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, also take part in the work. ISO collaborates closely with the International Electrote

21、chnical 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 committees is to prepare International Standards. Draft International Standards adopted by

22、 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 possibility that some of the elements of this document may be the subject of patent rig

23、hts. 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. This corrected version of ISO 18415:2007 contains the following corrections: p. 2, 3.6.1: modification of definition; p. 3, 3.8: correction of te

24、rms number; p.8, 9.7.1: correction of text in the second paragraph. SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 18415:2007(E) ISO 2007 All rights reserved vIntroduction Microbiological examinations of cosmetic products

25、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; pathogenicity of microorganisms; site of application of

26、 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 Candida albicans may be relevant because they can

27、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. SANS 18415:2009This s tandard may only be used and p

28、rinted by approved subscription and freemailing clients of the SABS .SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 18415:2007(E) ISO 2007 All rights reserved 1Cosmetics Microbiology Detection of spe

29、cified 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 identification of other kinds of aerobic mesophilic non-specified microorganisms

30、 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 microorganisms include one or more of the following species: Pseudomonas aeruginosa,

31、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 types of cosmetic product to which this International Standard is applicable. P

32、roducts 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 detection of microbial growth in a non-selective liquid medium (enrichment broth) suit

33、able 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 specific indications are given for identification of Pseudomonas aeruginosa, Esch

34、erichia 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 scheme (see Annex A). Other standards (e.g., ISO 18416, ISO 21150, ISO 22717, ISO 2

35、2718) 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). Other methods (e.g. automated) can be substituted for the test presented here prov

36、ided 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 references, only the edition cited applies. For undated references, the latest edi

37、tion of the referenced document (including any amendments) applies. ISO 21148:2005, Cosmetics Microbiology General instructions for microbiological examination EN 12353, Chemical disinfectants and antiseptics Preservation of test organisms used for the determination of bactericidal, mycobactericidal

38、, sporicidal and fungicidal activity SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 18415:2007(E) 2 ISO 2007 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions

39、 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 3.3 initial suspension suspension (or solution) of the sample in a defined volume o

40、f an appropriate enrichment broth 3.4 sample dilution 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

41、(e.g. molds) are detectable. 3.6 specified microorganisms 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 aerug

42、inosa Gram-negative rod (bacilli), motile, smooth colonies 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 (py

43、ocyanin) in suitable media. NOTE 2 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 f

44、or its potential pathogenicity and 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

45、of indole, growth on selective medium 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 grap

46、e-like clusters, smooth colonies generally pigmented in yellow NOTE 1 The main characteristics for identification are growth on a specific selective medium, catalase positive, coagulase positive. SANS 18415:2009This s tandard may only be used and printed by approved subscription and freemailing clie

47、nts of the SABS .ISO 18415:2007(E) ISO 2007 All rights reserved 3NOTE 2 Staphylococcus aureus is an opportunistic pathogen for humans, which often can be also present on the skin of healthy individuals without causing them any apparent illness. It is a specified microorganism and undesirable in cosm

48、etic 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 characteristics for identification are production of germ tube and/or pseudomycelium and chlamydospore when the test is performed following th

49、e method specified in this International Standard 3.7 non-specified microorganism aerobic mesophilic bacteria or yeast found in cosmetic products, not defined in 3.6 3.8 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 ingr