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BS EN ISO 18415:2017

BS EN ISO 18415:2017

$142.49

Cosmetics. Microbiology. Detection of specified and non-specified microorganisms

Published By Publication Date Number of Pages
BSI 2017 30
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This document 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 in cosmetic products.

Microorganisms considered as specified in this document 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, 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 to determine the types of cosmetic products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.

The method described in this document is based on the detection 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 document specific 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 document 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 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). Other methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Principle
5 Diluents and culture media
5.1 General
5.2 Diluent for the microbial suspension (tryptone sodium chloride solution)
5.2.1 General
12 5.2.2 Composition
5.2.3 Preparation
5.3 Culture media
5.3.1 General
5.3.2 Enrichment broth
13 5.3.3 Non-selective agar medium
6 Apparatus and glassware
14 7 Strains of microorganism
8 Handling of cosmetic products and laboratory samples
9 Procedure
9.1 General recommendations
9.2 Preparation of the initial suspension in the enrichment broth
9.2.1 General
15 9.2.2 Water-miscible products
9.2.3 Water-immiscible products
9.2.4 Filterable products
9.3 Incubation of the initial suspension
9.4 Isolation of specified and non-specified microorganisms
9.5 Procedure for identification of the specified microorganism: Pseudomonas aeruginosa
9.5.1 Gram staining
9.5.2 Oxidase test
16 9.5.3 Identification test
9.6 Procedure for identification of the specified microorganism: Escherichia coli
9.6.1 Gram staining
9.6.2 Oxidase test
9.6.3 Identification test
9.7 Procedure for identification of the specified microorganism: Staphylococcus aureus
9.7.1 Gram staining
9.7.2 Catalase test
9.7.3 Identification test
17 9.8 Procedure for the identification of the specified microorganism: Candida albicans
9.8.1 Gram staining
9.8.2 Identification test
9.9 Procedure for the identification of non-specified microorganisms
9.9.1 Gram staining
9.9.2 Oxidase test
9.9.3 Catalase test
9.9.4 Identification test
18 10 Expression of the results
10.1 Detection of specified microorganisms
10.2 Detection of non-specified microorganisms
10.3 Absence of microorganisms
11 Neutralization of the antimicrobial properties of the product
11.1 General
11.2 Preparation of inoculum
11.3 Suitability of detection method by enrichment
11.3.1 Principle
19 11.3.2 Procedure
11.3.3 Interpretation of suitability test results
12 Test report
21 Annex A (informative) General scheme for identification of microorganisms
22 Annex B (informative) Other media
25 Annex C (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids
27 Bibliography

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BS EN ISO 18415:2017
$142.49