20160127 ECA新闻：ISO 14644---第1部分：漫长等待后洁净室分级的最终版本

20160127 ECA新闻：ISO 14644---第1部分：漫长等待后洁净室分级的最终版本  

GMP News
27/01/2016

ISO 14644 - Part 1: The Long-Awaited Final Version on Cleanroom Classification

ISO 14644---第1部分：漫长等待后洁净室分级的最终版本

Part 1 of ISO 14644 entitled "Classification of air cleanliness by particle concentration" is one of the most  important norms in the GMP environment as it is the only technical norm which is directly referred to in an official GMP guideline document: the currently applicable Annex 1 of the EU GMP Guide. This norm is decisive and has to be used for the classification of cleanrooms used for GMP production. It contains the tables of cleanroom classes and their respective maximum of permitted number of particles as well as instructions on how to perform particle measuring.

ISO 14644第一部分题为“根据颗粒浓度进行空气洁净度分级”是GMP环境中最重要的标准，因为它只是技术标准，在官方GMP指南“现行EU GMP指南适用附录1”文件中被直接引用。在其中有一个洁净区分级的表格，其相应的允许颗粒物最大数量，以及如何测量颗粒物浓度。

The revision of the norm had already started in 2007. Many drafts have been published, e.g. in 2011, 2012, 2014 and 2015 but not a single one of them could achieve the final status. All the time, the version of 1999 has been applicable.

标准修订始于2007年。期间公布了许多版本的草案，如2011年、2012年、2014年和2015年，但其中没有一个最终成为正式文件。因此，在此期间仍适用1999年版本。

Now, since the end of 2015, the final version in English of the ISO 14644-1 is available from the publisher Beuth.

现在，自2015年底，ISO 14644-1的英文版本可以从BEUTH出版商处获得。

Substantially, the new version  includes the following changes:

一如既往，新的版本包括以下变化：

• The number of measuring points is no longer calculated as the square root of the surface but given in a table.
• 测量点的数据不再使用表面的平方根计算，而是在一个表中给定
• 5 ?m particles for ISO 5 has been dropped from the limit value table.
• 5um粒径的颗粒物在ISO5级中从限度值表里拿掉了
• No more statistical UCL calculation: there is no need to perform an observation of all measuring points in the room any longer. Each single measuring point is considered individually and has to meet the limit value.
• 没有了UCL计算，在标准里不再需要对一个房间里所有测量点的值进行计算。每个单独的测量点被认为是独立的，必须符合其限度值。
• The tubing length to the particle counter should be less than 1 m.
• 粒子计数器的管道长度应短于1米
• The classification number, the sample volumes/ measuring period as well as the cancellation criterion remain unchanged compared to the version of 1999.
• 分级数，样品体积/测量时长以及取消标准保持1999版本的内容不变
  

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