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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