VDI 6300 Blatt 1-2016

Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities

VDI 6300 Blatt 1-2016 发布历史

Since 1990, production and use of genetically modified organisms (GMOs) in closed systems are subject to European law regulations. These oblige the member states to take care by national legislation that the human health and the environment are protected from harmful consequences of methods in genetic engineering. In Germany, this obligation was met for the first time in 1990 by decree of the Genetic Engineering Law (GenTG) and supplementary ordinances which, since then, are updated and developed further regularly. The standard describes the state of the art for the check of the security procedures as well as for sampling and analytics for the safe operation of genetic engineering facilities. Thus, it provides a well manageable and orienting support for the planning and implementation of a safe operation for genetic engineering facilities.

VDI 6300 Blatt 1-2016由德国机械工程师协会 DE-VDI 发布于 2016-05。

VDI 6300 Blatt 1-2016在国际标准分类中归属于: 07.080 生物学、植物学、动物学。

VDI 6300 Blatt 1-2016 发布之时，引用了标准

• DIN 10113-1-1997 食品行业设备和器皿表面细菌数量测定.第1部分:定量拭子法
• DIN 10113-2-1997 食品行业设备和器皿表面细菌数量测定.第2部分:半定量拭子法
• DIN 10113-3-1997 食品行业设备和器皿表面细菌数量测定.第3部分:使用培养基叠层提取设备的半定量分析法(冷湿敷法)
• DIN 12980-2005 实验室装置.细胞毒性物质操作用安全台
• DIN 58356-12-2000 过滤器元件.薄膜过滤器元件.第12部分:水用疏水性薄膜过滤器元件的综合试验
• DIN 58949-2-2014 消毒.蒸汽消毒装置.第2部分:要求
• DIN 58949-3-2012 消毒.蒸汽消毒设备.第3部分:效率测试
• DIN 58951-2-2003 灭菌.实验室蒸汽灭菌器.第2部分:仪器要求、使用和安装要求
• DIN EN 285-2009 灭菌.蒸汽灭菌器.大型灭菌器(包括修改件A2-2009).英文版本DIN EN 285-2009-08
• DIN EN 1422-2014 医用灭菌器.环氧乙烷灭菌器.要求和试验方法;德文版本EN 1422-2014
• DIN EN 1822-1-2011 高效空气滤清器(EPA,HEPA和ULPA).第1部分:分类,性能试验,标记;德文版本EN 1822-1-2009
• DIN EN 1822-2-2011 高效空气滤清器(EPA,HEPA和ULPA).第2部分:气溶胶产品,测量设备,颗粒计数统计;德文版本EN 1822-2-2009
• DIN EN 1822-3-2011 高效空气滤清器(EPA,HEPA和ULPA).第3部分:试验扁平片状过滤介质;德文版本EN 1822-3-2009

VDI 6300 Blatt 1-2016的历代版本如下：

• 2012年01月01日 VDI 6300 Blatt 1-2012 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
• 2014年11月01日 VDI 6300 BLATT 1-2014 Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
• 2016年05月 VDI 6300 Blatt 1-2016

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标准号

VDI 6300 Blatt 1-2016

发布日期

2016年05月

实施日期

废止日期

无

国际标准分类号

07.080

发布单位

DE-VDI

适用范围

Since 1990, production and use of genetically modified organisms (GMOs) in closed systems are subject to European law regulations. These oblige the member states to take care by national legislation that the human health and the environment are protected from harmful consequences of methods in genetic engineering. In Germany, this obligation was met for the first time in 1990 by decree of the Genetic Engineering Law (GenTG) and supplementary ordinances which, since then, are updated and developed further regularly. The standard describes the state of the art for the check of the security procedures as well as for sampling and analytics for the safe operation of genetic engineering facilities. Thus, it provides a well manageable and orienting support for the planning and implementation of a safe operation for genetic engineering facilities.