SANS 22718-2009 Cosmetics - Microbiology - Detection of Staphylococcus aureus《化妆品 微生物学 金黄色葡萄球菌的检测》.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 978-0-626-22943-6 SANS 22718:2009Edition 1ISO 22718:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Cosmetics Microbiology Detection of Staphylococcus

4、aureus This national standard is the identical implementation ISO 22718:2006 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 7911 Fax: +27 12 344

5、1568 www.sabs.co.za SABS SANS 22718:2009 Edition 1 ISO 22718:2006 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 Division, in compliance with

6、 annex 3 of the WTO/TBT agreement. This SANS document was published in September 2009. Reference numberISO 22718:2006(E)ISO 2006INTERNATIONAL STANDARD ISO22718First edition2006-02-01Cosmetics Microbiology Detection of Staphylococcus aureus Cosmtiques Microbiologie Dtection de Staphylococcus aureus S

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12、 Published in Switzerland ii ISO 2006 All rights reservedSANS 22718:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22718:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative referen

13、ces . 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). 3 5.3 Culture media 3 6 Apparatus and glassware 6 7 Strains of microorganisms 6 8 Handling of cosmetic products and laboratory

14、 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 . 7 9.4 Detection and Identification of Staphylococcus aureus. 7 10 Expression of the results (detection of Staphylococcus aur

15、eus) . 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 report . 10 Annex A (informative) Other media 11 Annex B (informative) Neutralizers of antimicrobial activity of preservatives

16、 and rinsing liquids . 14 Bibliography . 15 SANS 22718:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22718:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide feder

17、ation of national standards bodies (ISO member bodies). The work of preparing International 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 commit

18、tee. International organizations, governmental and non-governmental, in liaison with ISO, 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 accordanc

19、e 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 the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires a

20、pproval 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 rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22718 was prepared by Technical Com

21、mittee ISO/TC 217, Cosmetics. SANS 22718:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22718:2006(E) ISO 2006 All rights reserved vIntroduction Microbiological examinations of cosmetic products shall be carried out according to an a

22、ppropriate 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 micro-organisms; site of application of the cosmetic product (hair, ski

23、n, 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 aeruginosa and Candida albicans may be relevant. The detection of other kinds of micro-organism might

24、 be of interest since these micro-organisms (including indicators of faecal contamination e.g. Escherichia coli) suggest hygienic failure during manufacturing process. SANS 22718:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 22718:

25、2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 22718:2006(E) ISO 2006 All rights reserved 1Cosmetics Microbiology Detection of Staphylococcus aureus 1 Scope This International Standard gives general guidelines

26、for the detection and identification of the specified micro-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 qual

27、ity and safety for consumers, it is advisable to perform 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-

28、alcoholic products, extreme pH values, etc. The method 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

29、level of detection required. NOTE For the detection of 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, th

30、is method may not be appropriate for some products in every 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 demons

31、trated 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 edition of the referenced document (including

32、any amendments) applies. ISO 21148:2005, Cosmetics Microbiology 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 p

33、urposes of this document, the following terms and definitions 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 SANS 22718:2009This s

34、tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22718:2006(E) 2 ISO 2006 All rights reserved3.3 initial suspension suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth 3.4 sample dilution(s) dilution(s) o

35、f the initial suspension 3.5 specified micro-organism aerobic mesophilic bacteria or 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

36、aureus Gram-positive cocci, mainly joined in grape-like clusters, smooth colonies generally 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 pathoge

37、n bacterium for humans that can be also present on the skin of healthy people without 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 v

38、alidated 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 micro-organisms without the risk of inhibition by the selective ingredients that are present in selective/differential growth me

39、dia. The second step (isolation) of the test is performed on a selective medium followed 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 neutrali

40、zation 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 21148. When water is mentioned in this document, use distilled water or purified water as specified in ISO 21148. The enrichmen

41、t 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. The efficacy of the neutralization shall be demonstrated (see Clause 11). Information relative to suitable neutralizers is g

42、iven in Annex B. The following enrichment broth is suitable for checking the presence 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 sui

43、table for use. SANS 22718:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 22718:2006(E) ISO 2006 All rights reserved 35.2 Diluent for the bacterial suspension (tryptone sodium chloride solution) 5.2.1 General The diluent is used for t

44、he 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 Preparation Dissolve the components in water by mixing whilst heating. Dispense into suitable containers.

45、 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 media may be prepared using the descriptions provided below or from dehydrated culture media accordi

46、ng to the instructions from 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 comparable to those of the formulas given herein. 5.3.2 Agar medium for validation (see Clause

47、11) soybean-casein digest agar medium (SCDA) or tryptic soy agar (TSA) 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 Dissolve the components or the dehydrated complete medium in the wate

48、r by mixing while 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. SANS 22718:2009This s tandard may only be used and printed by approv

49、ed subscription and freemailing clients of the SABS .ISO 22718:2006(E) 4 ISO 2006 All rights reserved5.3.3 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