VDI 2083 Blatt 16.1-2010

Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification

VDI 2083 Blatt 16.1-2010 发布历史

This guideline provides guidance for the planning, manufacture/installation, commissioning and operation of barrier systems in contamination control. Planer, manufacturer and user of clean environments must define, and lay down in writing, the requirements to be met by the product and its environment. The scope of this guideline includes any type of barrier between the room and the process environment, which serves for contamination control, expressly including dynamic (flow) as well as solid barriers. All types of contamination (particulate, chemical/molecular, biological) are included. The guideline supplements DIN EN ISO 14644-7 in practical aspects.

VDI 2083 Blatt 16.1-2010由德国机械工程师协会 DE-VDI 发布于 2010-08。

VDI 2083 Blatt 16.1-2010在国际标准分类中归属于: 13.040.35 清洁室（无菌室）及相关受控环境。

VDI 2083 Blatt 16.1-2010 发布之时，引用了标准

• DIN 12980-2005 实验室装置.细胞毒性物质操作用安全台
• DIN EN 374-2-2003 耐化学腐蚀和微生物的防护手套.第2部分:耐渗透性的测定
• DIN EN 374-3-2003 耐化学腐蚀和微生物的防护手套.第3部分:耐化学品渗透性的测定
• DIN EN 1779-1999 无损检验.泄漏检验.选择检验方法和检验技术的标准
• DIN EN 12469-2000 生物技术.微生物安全箱的性能标准
• DIN EN 14175-1-2003 通风柜.第1部分:词汇
• DIN EN 14175-2-2003 通风橱.第2部分:安全和性能要求
• DIN EN 14175-3-2004 通风柜.第3部分:定型试验方法
• DIN EN 14175-4-2004 通风柜.第4部分:现场试验方法
• DIN EN 14175-6-2006 通风柜.第6部分:空气变量通风柜
• DIN EN 61511-1-2005 功能安全.加工工业部门用安全仪表化系统.第1部分:框架、定义、系统、硬件和软件要求
• DIN EN ISO 14644-7-2005 洁净室和相关控制环境.第7部分:分离设备(洁净空气罩、手套式操作箱、分离器和微环境)

VDI 2083 Blatt 16.1-2010的历代版本如下：

• 2010年08月 VDI 2083 Blatt 16.1-2010

VDI 2083 Blatt 16.1-2010 由 VDI 2083 Blatt 16-2009 变更而来。

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标准号

VDI 2083 Blatt 16.1-2010

发布日期

2010年08月

实施日期

废止日期

无

国际标准分类号

13.040.35

发布单位

DE-VDI

适用范围

This guideline provides guidance for the planning, manufacture/installation, commissioning and operation of barrier systems in contamination control. Planer, manufacturer and user of clean environments must define, and lay down in writing, the requirements to be met by the product and its environment. The scope of this guideline includes any type of barrier between the room and the process environment, which serves for contamination control, expressly including dynamic (flow) as well as solid barriers. All types of contamination (particulate, chemical/molecular, biological) are included. The guideline supplements DIN EN ISO 14644-7 in practical aspects.