ISO 14644-17:2021 Cleanrooms and associated controlled environments —Part 17: Particle deposition rate applications

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Cleanrooms and associated controlled environments —Part 17: Particle deposition rate applications是于2021-02发布的ISO标准，适用于全球范围。

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标准部分原文

Cleanrooms and associated controlled environments —

Part 17: Particle deposition rate applications

1 Scope

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.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 14644-3:2019, Cleanrooms and associated controlled environments — Part 3: Test methods

3 Terms a nd definiti ons

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp

— IEC Electropedia: available at http:// www.e lectropedia .org/

3.1

cleanroom

room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room

Note 1 to entry: The class of airborne particle concentration is specified.

Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.

Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.

[SOURCE: ISO 14644-1:2015, 3.1.1]

3.2

clean zone

defined space within which the number concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation, and retention of contaminants inside the space

Note 1 to entry: The class of airborne particle concentration is specified.

Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.

Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom (3.1) or might be achieved by a separative device. Such a device can be located inside or outside a cleanroom.

Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.

[SOURCE: ISO 14644-1:2015, 3.1.2]

3.3

critical particle size

smallest particle size (3.7) that negatively impacts on product or process quality

3.4

critical location

location where a vulnerable surface (3.12) is exposed to particle contamination

3.5

operational

agreed condition where the cleanroom (3.1) or clean zone (3.2) is functioning in the specified manner, with equipment operating and with the specified number of personnel present

[SOURCE: ISO 14644-1:2015, 3.3.3]

3.6

particle

minute piece of matter with defined physical boundaries

[SOURCE: ISO 14644-1:2015, 3.2.1]

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