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EN ISO 18415:2017

Current
Current

The latest, up-to-date edition.

Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)
Published date

21-06-2017

European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Diluents and culture media
6 Apparatus and glassware
7 Strains of microorganism
8 Handling of cosmetic products and laboratory samples
9 Procedure
10 Expression of the results
11 Neutralization of the antimicrobial properties of the
   product
12 Test report
Annex A (informative) - General scheme for identification of
        microorganisms
Annex B (informative) - Other media
Annex C (informative) - Neutralizers of antimicrobial
        activity of preservatives and rinsing liquids
Bibliography

ISO 18415:2017 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 ISO 18415:2017 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.

Committee
CEN/TC 392
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current

ISO 29621:2017 Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products
ISO 21149:2017 Cosmetics — Microbiology — Enumeration and detection of aerobic mesophilic bacteria
ISO 22718:2015 Cosmetics Microbiology Detection of Staphylococcus aureus
EN 12353:2013 Chemical disinfectants and antiseptics - Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity
ISO 22717:2015 Cosmetics Microbiology Detection of Pseudomonas aeruginosa
ISO 16212:2017 Cosmetics — Microbiology — Enumeration of yeast and mould
ISO 18416:2015 Cosmetics Microbiology Detection of Candida albicans
ISO 21148:2017 Cosmetics — Microbiology — General instructions for microbiological examination
EN 1040:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1)
ISO 21150:2015 Cosmetics Microbiology Detection of Escherichia coli

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