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现行 ISO 14644-17:2021
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Cleanrooms and associated controlled environments — Part 17: Particle deposition rate applications 洁净室和相关控制环境.第17部分:颗粒沉积速率应用
发布日期: 2021-02-12
作为污染控制计划的一部分,本文件给出了洁净室中一个或多个脆弱表面上颗粒沉积速率测量结果的解释和应用方向。它提供了一些关于如何影响颗粒沉积速率和降低易受损伤表面上颗粒污染风险的说明。 本文件提供了洁净室用户如何使用颗粒沉积速率测量值来确定易受伤害表面上大颗粒的限制的信息。 它还提供了一种风险评估方法,通过该方法,可以确定颗粒沉积到洁净室易受伤害表面上的可接受风险,如果达不到这一点,还可以使用一些方法来降低颗粒沉积速率。 颗粒沉积速率的另一种替代方法是颗粒遮蔽速率,它决定了随着时间的推移,颗粒在表面区域的覆盖率增加的速率。粒子遮蔽率可以与粒子沉积率类似的方式使用,并且可以计算指定表面所需的粒子遮蔽率,从而降低沉积粒子的风险。 本文件不包括: -提供一种根据颗粒沉积率或颗粒遮蔽率对洁净室进行分类的方法; -直接考虑微生物携带颗粒的沉积,尽管它们可以被视为颗粒; -考虑通过接触产生的表面沉积,例如,当人员接触产品并转移污染物时。
This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the particle deposition rate and reduce the risk of particle contamination on vulnerable surfaces. This document gives information on how a cleanroom user can use the particle deposition rate measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the particle deposition rate. An alternative to the particle deposition rate is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The particle obscuration rate can be used in an analogous way to the particle deposition rate and the required particle obscuration rate for a specified surface can be calculated and the risk from deposited particles reduced. This document does not: — provide a method to classify a cleanroom with respect to particle deposition rate or particle obscuration rate; — directly consider the deposition of microbe-carrying particles, although they can be treated as particles; — give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.
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归口单位: ISO/TC 209
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