ISO 18362:2016规定了基于风险的方法处理需要控制活的和非活的微生物污染的基于细胞的保健产品（CBHP）的最低要求，并提供了指导。它既适用于标记为“无菌”的CBHP，也适用于未标记为“无菌”的CBHP。 ISO 18362:2016不适用于: -采购和运输用于加工CBHP的基于细胞的起始材料， -细胞库， -遗传物质的控制， -控制非微生物产品污染， -体外诊断(IVD)，或 -天然药物。 例如维生素和矿物质、草药、顺势疗法药物、传统药物如中药、益生菌、其他产品如氨基酸和必需脂肪酸。 ISO 18362:2016没有定义生物安全遏制要求。 ISO 18362:2016不能取代适用于CBHP制造和质量控制的国家或地区法规。

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.