标准号:BS EN 12307-1998
中文标准名称:生物技术.大型工艺流程和生产.良好的操作惯例和工序,人员的培训和管理的指南
英文标准名称:Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
标准类型:C04
发布日期:1998/3/15 12:00:00
实施日期:1998/3/15 12:00:00
中国标准分类号:C04
国际标准分类号:07.080;07.100.99
适用范围:This European Standard gives guidance for good practice, procedures, training and control for the operation of large scale biotechnological processes.
NOTE. For laboratories associated with a large scale process, attention is drawn to prEN 12741 (see annex A [8]).
In addition, this European Standard gives recommendations for education and training of personnel involved in the large scale handling of micro-organisms in plant building of containment levels 1, 2, 3 and 4 (see EN 1620).
This European Standard aims at the protection of the workers from biological hazards as well as the environment including plants and animals.
For operations using micro-organisms only pathogenic for the environment (plant or some animal pathogens e.g. foot and mouth disease virus), this European Standard should be adapted according to the risk for environment and taking into account the recommendations of the national competent authorities.
This European Standard is complemented by:
- physical containment which requirements are given in EN 1620 ; and
- personal protective equipment which requirements are given in EN 143, EN 166, EN 374-1 and EN 374-3.