標準號：BS EN ISO 18415-2011
中文標準名稱：化妝品.微生物學.專用和非專用微生物的探測
英文標準名稱：Cosmetics. Microbiology. Detection of specified and non-specified microorganisms
標準類型：Y42
發布日期：2011/7/31 12:00:00
實施日期：2011/7/31 12:00:00
中國標準分類號：Y42
國際標準分類號：07.100.99;71.100.70
引用標準：ISO 21148-2005;EN 12353
適用范圍：This International Standard gives general guidelines for the detection and identification of specifiedmicroorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobicmesophilic non-specified microorganisms in cosmetic products.Microorganisms considered as specified in this International Standard might differ from country to countryaccording to national practices or regulations. Most of them considered as specified microorganisms includeone or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus andCandida albicans.In order to ensure product quality and safety for consumers, it is advisable to perform an appropriatemicrobiological risk analysis in order to determine the types of cosmetic product to which this InternationalStandard is applicable. Products considered to present a low microbiological risk include those with low wateractivity, hydro-alcoholic products, extreme pH values, etc.The method described in this International Standard is based on the detection of microbial growth in a nonselectiveliquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation ofmicroorganisms on non-selective agar media. Other methods can be appropriate depending on the level ofdetection required.In this International Standard specific indications are given for identification of Pseudomonas aeruginosa,Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under theconditions described in this International Standard, may be identified by using suitable tests according to ageneral scheme (see Annex A). Other standards (e.g., ISO 18416, ISO 21150, ISO 22717, ISO 22718) maybe appropriate.Because of the large variety of cosmetic products within this field of application, this method might not besuited 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 provided that their equivalence has beendemonstrated or the method has been otherwise validated.