化妆品.微生物学.特异性和非特异性微生物的检测

[中文适用范围]： 本文件为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需氧中温非特定微生物的检测和鉴定提供了一般指南。 根据国家惯例或法规，本文件中指定的微生物可能因国家/地区而异。 大多数被认为是特定微生物的微生物包括以下一种或多种：铜绿假单胞菌、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（参见 ISO 29621）包括低水分活度、水醇产品、极端 pH 值等。 本文件中描述的方法基于非选择性环境中微生物生长的检测。 适合检测微生物污染的液体培养基（增菌肉汤），然后在非选择性琼脂培养基上分离微生物。 根据所需的检测水平，其他方法也可能适用。 本文件给出了铜绿假单胞菌、大肠杆菌、金黄色葡萄球菌和白色念珠菌的鉴定的具体说明。 在本文件描述的条件下生长的其他微生物可以根据一般方案（见附件 A）使用适当的测试来鉴定。 其他标准（例如 ISO 18416、ISO 21150、ISO 22717、ISO 22718）可能也适用。 由于该应用领域内的化妆品种类繁多，因此该方法可能并不适合某些产品（例如某些与水不混溶的产品）。 其他方法（例如自动方法）可以替代此处介绍的测试，只要它们的等效性已得到证明或该方法已被证明是合适的。 [外文原描述]： 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.