BS EN 12689-1998 生物技术.微生物制品的纯度,生物活性和稳定性评估指南

标准号：BS EN 12689-1998
中文标准名称：生物技术.微生物制品的纯度,生物活性和稳定性评估指南
英文标准名称：Biotechnology - Guidance on assessment of the purity, biological activity and stability of micro-organism based products
标准类型：C04
发布日期：1998/12/15 12:00:00
实施日期：1998/12/15 12:00:00
中国标准分类号：C04
国际标准分类号：07.080;07.100.01
适用范围：This European Standard gives guidance on the assessment of technical specifications of micro-organism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. In this European Standard, the technical specifications are considered to be purity, biological activity and stability of the micro-organism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications. This European Standard only applies to the microbial components of a MBP as a whole and does not apply to any type of molecular components purified from the micro-organism. This European Standard applies to MBPs specifically manufactured to be used in agriculture and in the environment. This European Standard does not apply to MBPs used either in food industry, for veterinary use or for human health. NOTE 2 This European Standard can be used by the manufacturer of MBPs or anyone interested in the evaluation of product quality. NOTE 3 Due to rapid evolution in this field, it is recommended that the user should consult existing applicable national, European and international standards. NOTE 4 Technical specification assessment is consistent with the need for protection of human health, animal and environmental safety.