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现行 EN ISO 18415:2017
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Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017) 化妆品 - 微生物学 - 检测特定和非特定微生物(ISO/FDIS 18415:2017)
发布日期: 2017-06-21
实施日期: 2017-06-21
ISO 18415:2017给出化妆品中特定微生物的检测和鉴定以及化妆品中其他种类嗜酸性非特异性微生物的检测和鉴定的一般准则。 根据国家惯例或法规,本文件中规定的微生物可能因国家而异。大多数被认为是指定的微生物包括一种或多种以下物质:绿脓假单胞菌,大肠杆菌,金黄色葡萄球菌和白色念珠菌。 为了确保消费者的产品质量和安全,建议进行适当的微生物风险分析,以确定本文件适用的化妆品类型。被认为具有低微生物风险的产品(见ISO 29621)包括水分低,含水酒精产品,极端pH值等。 本文件描述的方法是基于适合于检测微生物污染的非选择性液体培养基(富集肉汤)中微生物生长的检测,然后在非选择性琼脂培养基上分离微生物。其他方法可以根据不同的水平进行需要检测 在ISO 18415:2017中给出了鉴定铜绿假单胞菌,大肠杆菌,金黄色葡萄球菌和白色念珠菌的具体适应症。在本文档描述的条件下生长的其他微生物可以通过使用根据一般方案的合适的测试来鉴定(见附件A)。其他标准(例如ISO 18416,ISO 21150,ISO 22717,ISO 22718)可能是适当的。 由于在这一应用范围内各种各样的化妆品,这种方法可能不适用于某些产品(例如某些水不混溶产品)的每个细节。其他方法(例如自动化)可替代本文提供的测试,只要其等同性已被证明或该方法已被证明是合适的。
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.
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归口单位: CEN/TC 392-
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