基于细胞的健康护理产品的制造. 加工过程中的微生物风险控制

[中文适用范围]： 本国际标准指定了细胞基医疗器械产品（CBHPs）在加工过程中控制活微生物和非活性微生物污染的基本要求，并提供了基于风险的方法的指导。其适用于标记为‘无菌’的CBHPs，也适用于未标记为‘无菌’的CBHPs。 本国际标准不适用以下情况：——细胞基原材料的采购和运输（用于CBHP加工），——细胞库建立，——遗传物质控制，——非微生物产品污染控制，——体外诊断（IVDs），或——天然药物。例如维生素、矿物质、草药制剂、顺势疗法药品、传统药物（如中医药）、益生菌、其他产品（如氨基酸和必需脂肪酸）。本国际标准未定义生物安全 containment 要求。 本国际标准不取代适用于CBHP制造和质量控制的国家或地区法规。 [外文原描述]： ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'. ISO 18362:2016 is not applicable to: - procurement and transport of cell-based starting material used in processing of a CBHP, - cell banking, - control of genetic material, - control of non-microbial product contamination, - in vitro diagnostics (IVDs), or - natural medicines. EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids. ISO 18362:2016 does not define biosafety containment requirements. ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.