ISO 18362:2016 基于细胞的医疗保健产品的生产 加工过程中微生物风险的控制

标准编号：ISO 18362:2016

中文名称：基于细胞的医疗保健产品的生产 加工过程中微生物风险的控制

英文名称：Manufacture of cell-based health care products — Control of microbial risks during processing

发布日期：2016-02

标准范围

This International Standard specifies the minimum requirements for, and provides guidance on, arisk-based approach for the processing of cell-based health care products (CBHPs) requiring control ofviable and non-viable microbial contamination. It is applicable both to CBHPs labelled ‘sterile’ and toCBHPs not labelled ‘sterile’.This International Standard 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 astraditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.This International Standard does not define biosafety containment requirements.This International Standard does not replace national or regional regulations that apply to themanufacture and quality control of a CBHP.

标准预览图