標(biāo)準(zhǔn)號:BS EN 12307-1998
中文標(biāo)準(zhǔn)名稱:生物技術(shù).大型工藝流程和生產(chǎn).良好的操作慣例和工序,人員的培訓(xùn)和管理的指南
英文標(biāo)準(zhǔn)名稱:Biotechnology - Large-scale process and production - Guidance for good practice, procedures, training and control for personnel
標(biāo)準(zhǔn)類型:C04
發(fā)布日期:1998/3/15 12:00:00
實施日期:1998/3/15 12:00:00
中國標(biāo)準(zhǔn)分類號:C04
國際標(biāo)準(zhǔn)分類號:07.080;07.100.99
適用范圍: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.
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