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ISO 14644

ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1.[1]


ISO 14644

ISO 14644-1: 

Cleanroom Air Cleanliness Classification


  • ISO 14644-1:2015 Overview

    ISO 14644-1:2015 specifies air cleanliness classification based on airborne particle concentrations, from 0.1 µm to 5 µm, in cleanrooms and clean zones.

  • Particle Size Range

    The standard focuses on particle populations within the range of 0.1 µm to 5 µm, using cumulative distributions for classification purposes.

  • Measurement Methodology

    Light scattering airborne particle counters (LSAPC) are used to measure airborne particle concentrations at specific sampling locations.

  • Exclusions in Classification

    ISO 14644-1:2015 does not address particles outside the 0.1 µm to 5 µm range. Ultrafine particles will be covered by a separate standard.

  • Macroparticles Classification

    The M descriptor in Annex C is used to quantify macroparticles (larger than 5 µm) in cleanrooms, as per the standard’s guidance.

  • Limitations of ISO 14644-1

    This standard cannot characterize the physical, chemical, radiological, or viable nature of airborne particles, focusing solely on particle concentration.



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ISO 14644-2:2015

Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration


  • Overview of ISO 14644-2:2015

    ISO 14644-2:2015 specifies the minimum requirements for monitoring cleanroom performance, focusing on airborne particle concentration.

  • Monitoring Focus

    The standard emphasizes monitoring parameters that measure or affect airborne particle concentration in cleanrooms and clean zones.

  • Exclusions from Scope

    ISO 14644-2:2015 does not address condition monitoring for vibration or the general maintenance of engineering systems in cleanrooms.

  • Particle Size Range

    It excludes monitoring for particles outside the 0.1 µm to 5 µm range, with ultrafine particles being covered by a separate standard.

  • Limitations in Monitoring

    The standard is focused solely on particle concentration and does not provide guidelines for monitoring the physical, chemical, or other nature of airborne particles.



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ISO 14644-3:2019 

Cleanrooms and associated controlled environments Part 3: Test methods


  • Overview of Test Methods

    This document provides test methods for cleanrooms and clean zones to meet air cleanliness and other controlled conditions, supporting operational performance.

  • Types of Cleanrooms and Occupancy States

    Performance tests apply to cleanrooms with unidirectional or non-unidirectional airflow, in three occupancy states: as-built, at-rest, and operational.

  • Test Procedures and Apparatus

    The document specifies recommended test methods, apparatus, and procedures for determining performance parameters, with alternative procedures based on cleanroom type.

  • Alternative Methods

    Alternative methods, not included in the document, may be used by agreement between customer and supplier but may not provide equivalent measurements.

  • Exclusions and Limitations

    This document does not apply to product or process measurements and does not address safety considerations when using hazardous materials or equipment.

  • Safety and Health Considerations

    Users are responsible for establishing appropriate safety practices and ensuring compliance with relevant regulatory limitations.



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ISO 14644-4:2022 

Design, construction and start-up


  • Overview of Cleanroom Process

    This document outlines the process for creating a cleanroom, from requirements to design, construction, and start-up, covering new, refurbished, and modified installations.

  • Target Audience

    It is intended for users, specifiers, designers, purchasers, suppliers, builders, and performance verifiers of cleanroom installations.

  • Focus on Airborne Particle Concentration

    The primary cleanliness consideration is controlling airborne particle concentration, with checklists provided for all stages of cleanroom development.

  • Energy Management Considerations

    Energy-efficient design approaches are included, ensuring cleanroom operations are sustainable and aligned with energy management goals.

  • Construction and Start-up Guidance

    Detailed guidance is provided on cleanroom construction, including requirements for start-up and performance verification to ensure compliance.

  • Life Cycle Considerations

    The document emphasizes long-term maintenance and operational aspects to ensure satisfactory cleanroom performance throughout its life cycle.



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ISO 14644-5:2004 

Operating Requirements for Cleanrooms and Controlled Environments


  • Overview of ISO 14644-5:2004

    ISO 14644-5:2004 outlines basic operational requirements for cleanrooms, aimed at those planning to use and operate them.

  • Safety Considerations

    The standard does not address safety aspects unrelated to contamination control, which must comply with local and national regulations.

  • Broad Application

    It applies to all cleanroom classes used across various industries, without specifying requirements for individual sectors.

  • Monitoring Methods and References

    While routine monitoring methods are not detailed, references to other ISO standards (14644-2, 14644-3, 14698-1, 14698-2) are provided for particle and microorganism monitoring.

  • Focus on General Operational Guidelines

    The document provides general guidance for cleanroom operations, without addressing specific industry needs or monitoring protocols in-depth.



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ISO 14644-7:2004

Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)


  • Overview of ISO 14644-7:2004

    ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, testing, and approval of separative devices, differing from cleanrooms.

  • Limitations and Scope

    It considers user-agreed requirements but does not address application-specific needs, processes, or regulatory matters such as fire safety.

  • Regulatory Compliance

    National and local regulations apply where appropriate, but ISO 14644-7:2004 does not focus on safety aspects like fire or general regulations.

  • Exclusions from Applicability

    The standard is not applicable to full-suits, as it focuses specifically on separative devices used in controlled environments.




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ISO 14644-8:2022 Part 8: 

Assessment of air cleanliness by chemical concentration (ACC)


  • Overview of Chemical Cleanliness Assessment

    This document outlines the assessment process for determining air chemical cleanliness (ACC) levels in cleanrooms, focusing on airborne chemical concentrations.

  • Chemical Substance Measurement

    It addresses concentrations of specific chemical substances, including individual, group, or category levels, within cleanroom environments.

  • Test Methods and Protocol

    The document provides a protocol for test methods, analysis, and time-weighted factors to assess chemical cleanliness in controlled environments.

  • Scope of Chemical Concentrations

    It focuses on chemical concentrations ranging from 100 g/m3 to 10−12 g/m3 under cleanroom operational conditions.



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FAQ

Yes, EN ISO 14644-2 is the European equivalent of ISO 14644-2, with both standards covering cleanroom testing and monitoring procedures. Yes, EN ISO 14644-2 is a cleanroom monitoring guideline corresponding to the international ISO 14644-2.

Yes, EN ISO 14644-2 is the European equivalent of ISO 14644-2, with both standards covering cleanroom testing and monitoring procedures. Yes, EN ISO 14644-2 is a cleanroom monitoring guideline corresponding to the international ISO 14644-2.


What information does ISO 14644-2 provide?

ISO 14644-2 provides a guideline for cleanroom performance evaluation and specifies how often tests have to be performed.


Is EN ISO 14644-1?

Yes, EN ISO 14644-1 is the European norm ISO 14644-1 which gives cleanroom classification and clean air standards.


What is the meaning of ISO class 2?

ISO class 2 allows more than 1,000 particles measuring more than or equal to 0.5 micrometers within one cubic meter of air, and is usually used in very sensitive processes, such as in semiconductor industry.


What is the last version of ISO 14644?

The last version is ISO 14644:2015, which is updated with the cleanroom classification and air standard requirements.


What is ISO 14644-3?

ISO 14644-3 describes how to evaluate the cleanroom performance of various cleanroom systems.


What is ISO class 3 cleanroom?

ISO class 3 allows using more than 35 particles sized more than or equal to 0.5 micrometers in one cubic meter of air; it is suitable for very sensitive processes.


What is the meaning of ISO 14644-2?

ISO 14644-2 specifies cleanroom performance evaluation methods, indicating cleanroom conditions and how clean air can be achieved.


What is the meaning of ISO 14644-4?

ISO 14644-4 describes design methods and operational techniques.


What are the recent developments to ISO 14644-4?

The latest international standards ISO 14644-4 consist of revised regulations on airflow patterns and processes of air quality management systems for better contamination prevention and improvement of performance of clean rooms.


What is ISO 4 and ISO 5?

Classification ISO Class 4 permits less number of particles thus amounting to 2000 particles per cubic meter in contrast to ISO Class 5 – up to 3520. The air in Class 4 is cleaner therefore it is used in the most critical industry processes which require superior air purity.


What is the cleanroom air change rate denoted in ISO 14644-4?

According to the ISO standard 14644-4 the cleanroom air change rates depend on their classification.


What is ISO 14644-5?

ISO 14644-5 sets requirements for the cleanliness of the cleanroom environment during its operation, that include cleaning, maintenance and operations methods.


What is ISO Class 5?

ISO Class 5 classification signifies that there are 3520 particles of diameter larger than 0.5 micrometers in a cubic meter of air. It refers to high standards of cleanliness and is typical for industries like electronics and pharmaceuticals.


What is the cleanroom performance of ISO Class 5?

According to ISO Class 5 standard, the number of particles bigger than 0.5 micrometers should not exceed 3520 particles per cubic meter of air.


What is the difference between ISO Class 4 and ISO Class 5?

The distinction of ISO Class 4 and Class 5 is with respect to allowed level of particles count, which is stricter for the former.


What does ISO Class 6 cleanroom mean?

ISO Class 6 permits a maximum of 35,200 particles of size 0.5 micron or larger per cubic meter which could be important enough for various cleanroom use but not at much of an extent of the higher class ISO classifications.


What is the maximum amount of particles in ISO Class 6?

ISO Class 6 allows a maximum of 35,200 particles of size 0.5 micron or larger per cubic meter of air suitable enough for cleanroom use.


What is ISO 14644-5?

ISO 14644-5 deals with the operations which are required to maintain cleanrooms clean, which includes the procedures for monitoring, maintaining, and controlling contamination sources.


What is ISO 7 clean room classification?

ISO Class 7 allows a maximum of 352,000 particles of size 0.5 micron and larger in a cleanroom and can be used in cleanrooms which require good cleanliness for keeping the production processes clean.


What is ISO 8 cleanroom?

ISO Class 8 cleanrooms allow a maximum of 3,520,000 particles of size 0.5 microns or larger in a cleanroom which can be used for less important operations like food or cosmetic processing.


How is ISO 7 different from ISO 8?

ISO 7 allows fewer number of particles as compared to ISO 8 thus making it a better option when products being processed in cleanroom require difficult cleaning procedures.


What is ISO 14644-1 Class 8 standards?

ISO Class 8 allows 3,520,000 particles of size 0.5 microns and larger use in less important operations where cleanliness requirement is low.


What is ISO 8 used for?

ISO Class 8 is mainly used in fields in which air cleanliness is not such an important requirement like food processing and some types of packing.


What is ISO 9 cleanroom classification?

ISO Class 9 allows the biggest number of particles without any limits, meaning that this classification is for the cleanrooms where contamination control is not an important requirement.


What is the difference between ISO 14698 and ISO 14644?

ISO 14698 deals with the biocontamination control while ISO 14644 is focused on air cleanliness and general contamination control by counting particles and controlling the parameters of air.


What is ISO 14644-7?

ISO 14644-7 is providing us with the additional information which deals with particle counting in order to classify cleanrooms and to monitor them.


What is BS EN ISO 14644-10?

BS EN ISO 14644-10 provides us with additional information about the cleanrooms maintenance in terms of cleaning, keeping them clean and other procedures.

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