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13.040.35 - Cleanrooms and associated controlled environments

ICS 13.040.35 Details

Cleanrooms and associated controlled environments

Salles propres et environnements contrôlés apparentés

Brezprašni prostori in povezana nadzorovana okolja

General Information

Parent
13.040 - Air quality

Frequently Asked Questions

ICS 13.040.35 is a classification code in the International Classification for Standards (ICS) system. It covers "Cleanrooms and associated controlled environments". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.

There are 117 standards classified under ICS 13.040.35 (Cleanrooms and associated controlled environments). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.

The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN ISO 14644-5:2025(Main)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)
EN ISO 14644-5:2025

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
This document specifies operational requirements that relate to:
—     providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
—     training of personnel;
—     transferring, installing and maintaining stationary equipment;
—     transferring material and portable equipment into and out of the cleanroom;
—     maintaining a personnel management programme that includes a gowning programme;
—     maintaining a cleaning programme that addresses special cleaning;
—     maintaining a cleanroom maintenance programme;
—     establishing an appropriate monitoring programme.
This document gives additional information in annexes for:
—     personnel management;
—     gowning;
—     training;
—     cleaning.
This document does not specifically address biocontamination control. For details on this topic, see ISO 14698-1 and ISO 14698-2.
This document does not apply to the following topics:
—     aspects of health and safety management that have no direct bearing on contamination control;
—     specific requirements for individual industries;
—     specific requirements for equipment and materials used or associated with processes and products;
—     design details of equipment;
—     cleaning agent compatibility with cleanroom materials.

  • Standard
    32 pages
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CEN
EN ISO 14644-5:2025(Main)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)
SIST EN ISO 14644-5:2025

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
This document specifies operational requirements that relate to:
—     providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
—     training of personnel;
—     transferring, installing and maintaining stationary equipment;
—     transferring material and portable equipment into and out of the cleanroom;
—     maintaining a personnel management programme that includes a gowning programme;
—     maintaining a cleaning programme that addresses special cleaning;
—     maintaining a cleanroom maintenance programme;
—     establishing an appropriate monitoring programme.
This document gives additional information in annexes for:
—     personnel management;
—     gowning;
—     training;
—     cleaning.
This document does not specifically address biocontamination control. For details on this topic, see ISO 14698-1 and ISO 14698-2.
This document does not apply to the following topics:
—     aspects of health and safety management that have no direct bearing on contamination control;
—     specific requirements for individual industries;
—     specific requirements for equipment and materials used or associated with processes and products;
—     design details of equipment;
—     cleaning agent compatibility with cleanroom materials.

  • Standard
    32 pages
    English language
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ISO
ISO 14644-5:2025(Main)
Cleanrooms and associated controlled environments - Part 5: Operations

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring. This document specifies operational requirements that relate to: - providing a system that specifies policies and operational procedures for maintaining cleanliness levels; - training of personnel; - transferring, installing and maintaining stationary equipment; - transferring material and portable equipment into and out of the cleanroom; - maintaining a personnel management programme that includes a gowning programme; - maintaining a cleaning programme that addresses special cleaning; - maintaining a cleanroom maintenance programme; - establishing an appropriate monitoring programme. This document gives additional information in annexes for: - personnel management; - gowning; - training; - cleaning. This document does not specifically address biocontamination control. For details on this topic, see ISO 14698-1 and ISO 14698-2. This document does not apply to the following topics: - aspects of health and safety management that have no direct bearing on contamination control; - specific requirements for individual industries; - specific requirements for equipment and materials used or associated with processes and products; - design details of equipment; - cleaning agent compatibility with cleanroom materials.

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    24 pages
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    27 pages
    French language
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SIST
SIST EN ISO 14644-18:2023(Main)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)
EN ISO 14644-18:2023

This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
—     determination of cleanroom suitability of consumables in general;
—     specification of requirements for an intended use of a consumable by the customer with respect to functional performance, cleanliness attributes and special properties;
—     specification of properties for a designed use of a consumable by supplier;
—     assessment of a consumable for an appropriate use;
—     documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.
Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables.
This document does not apply to:
—     design details of consumables;
—     testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring;
—     health and safety requirements; legal requirements can apply in specific countries;
—     cleanability;
—     (raw) materials which are added within the production process as ingredients;
—     performance or function testing;
—     transport containers;
—     process media such as gases or liquids;
—     the functional performance of cleaning agents, disinfectants and lubricants.

  • Standard
    47 pages
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CEN
EN ISO 14644-18:2023(Main)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)
SIST EN ISO 14644-18:2023

This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered.
This document complements cleanroom operation as outlined in ISO 14644-5.
This document gives guidance concerning:
—     determination of cleanroom suitability of consumables in general;
—     specification of requirements for an intended use of a consumable by the customer with respect to functional performance, cleanliness attributes and special properties;
—     specification of properties for a designed use of a consumable by supplier;
—     assessment of a consumable for an appropriate use;
—     documentation.
Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom.
Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables.
This document does not apply to:
—     design details of consumables;
—     testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring;
—     health and safety requirements; legal requirements can apply in specific countries;
—     cleanability;
—     (raw) materials which are added within the production process as ingredients;
—     performance or function testing;
—     transport containers;
—     process media such as gases or liquids;
—     the functional performance of cleaning agents, disinfectants and lubricants.

  • Standard
    47 pages
    English language
    e-Library read for
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ISO
ISO 14644-18:2023(Main)
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables

This document gives guidance for assessing personal and non-personal consumables for their appropriate use in cleanrooms, clean zones or controlled zones, based on product and process requirements, cleanliness attributes and functional performance properties. The cleanliness attributes addressed are particles or chemicals in air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered as a special property of consumables. Identification of associated risks are considered. This document complements cleanroom operation as outlined in ISO 14644-5. This document gives guidance concerning: - determination of cleanroom suitability of consumables in general; - specification of requirements for an intended use of a consumable by the customer with respect to functional performance, cleanliness attributes and special properties; - specification of properties for a designed use of a consumable by supplier; - assessment of a consumable for an appropriate use; - documentation. Informative annexes are used to list examples for personal and non-personal consumables, verification methods for cleanliness attributes testing and the potential impact of consumables on a cleanroom. Cleaning agents, disinfectants and lubricants are considered as consumables with respect to their packaging, as their packaging is likely to have cleanliness requirements in common with all consumables. This document does not apply to: - design details of consumables; - testing of functional performance of materials, e.g. barrier properties of gloves, wear and slip resistance of flooring; - health and safety requirements; legal requirements can apply in specific countries; - cleanability; - (raw) materials which are added within the production process as ingredients; - performance or function testing; - transport containers; - process media such as gases or liquids; - the functional performance of cleaning agents, disinfectants and lubricants.

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    38 pages
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    41 pages
    French language
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ISO
ISO/TR 14644-21:2023(Main)
Cleanrooms and associated controlled environments - Part 21: Airborne particle sampling techniques

This document discusses the physical limitations of probe and particle counter placement, and any tubing that connects the two, particularly in providing representative samples where particles 5 micrometres and greater are of interest. The document further identifies the key factors of sampling performance when classifying and monitoring, and good practice to determine and maintain an acceptable compromise between attainable accuracy in counting and feasibility of counting in real-life situations. This document includes a decision tree, used to identify key considerations when sampling airborne particles, and whether the system requires further assessment. There are also examples provided to illustrate typical application challenges and show how the decision tree can be used. It is assumed that this document is read in conjunction with ISO 14644-1 and ISO 14644-2. This document is not a manual, but an explanatory document. It does not describe measurement methods, which is handled in ISO 14644-1 and ISO 14644-2, but provides information to help make effective choices of sampling configuration, when evaluating a new or existing system.

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    26 pages
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CEN
EN ISO 14644-8:2022(Main)
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
SIST EN ISO 14644-8:2022

This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions.
This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of this document to describe the nature of air chemical contaminants.
This document does not give a classification of surface chemical contamination.

  • Standard
    30 pages
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SIST
SIST EN ISO 14644-4:2023(Main)
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)
EN ISO 14644-4:2022

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE       Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
—    specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
—    fire and safety regulations;
—    ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

  • Standard
    65 pages
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CEN
EN ISO 14644-4:2022(Main)
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)
SIST EN ISO 14644-4:2023

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE       Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
—    specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
—    fire and safety regulations;
—    ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

  • Standard
    65 pages
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CEN
EN ISO 14644-9:2022(Main)
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)
SIST EN ISO 14644-9:2022

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D.
This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm.
The following issues are not considered in this document:
—    requirements for the cleanliness and suitability of surfaces for specific processes;
—    procedures for the cleaning of surfaces;
—    material characteristics;
—    references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
—    selection and use of statistical methods for assessment and testing;
—    other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

  • Standard
    34 pages
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CEN
EN ISO 14644-10:2022(Main)
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination (ISO 14644-10:2022)
SIST EN ISO 14644-10:2022

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.
NOTE 1    For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface.
NOTE 2    This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

  • Standard
    38 pages
    English language
    e-Library read for
    1 day
ISO
ISO 14644-4:2022(Main)
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom. NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments). The following subjects are mentioned but not addressed in this document: - specific operational activities, processes to be accommodated and process equipment in the cleanroom installation; - fire and safety regulations; - ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

  • Standard
    57 pages
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SIST
SIST EN ISO 14644-8:2022(Main)
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
EN ISO 14644-8:2022

This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions.
This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of this document to describe the nature of air chemical contaminants.
This document does not give a classification of surface chemical contamination.

  • Standard
    30 pages
    English language
    e-Library read for
    1 day
ISO
ISO 14644-8:2022(Main)
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC)

This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions. This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process. It is not the intention of this document to describe the nature of air chemical contaminants. This document does not give a classification of surface chemical contamination.

  • Standard
    22 pages
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    21 pages
    French language
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SIST
SIST EN ISO 14644-9:2022(Main)
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)
EN ISO 14644-9:2022

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D.
This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm.
The following issues are not considered in this document:
—    requirements for the cleanliness and suitability of surfaces for specific processes;
—    procedures for the cleaning of surfaces;
—    material characteristics;
—    references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
—    selection and use of statistical methods for assessment and testing;
—    other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

  • Standard
    34 pages
    English language
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SIST
SIST EN ISO 14644-10:2022(Main)
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination (ISO 14644-10:2022)
EN ISO 14644-10:2022

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.
NOTE 1    For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface.
NOTE 2    This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

  • Standard
    38 pages
    English language
    e-Library read for
    1 day
ISO
ISO 14644-9:2022(Main)
Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm. The following issues are not considered in this document: - requirements for the cleanliness and suitability of surfaces for specific processes; - procedures for the cleaning of surfaces; - material characteristics; - references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; - selection and use of statistical methods for assessment and testing; - other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

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    26 pages
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    26 pages
    French language
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ISO
ISO 14644-10:2022(Main)
Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices. NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface. NOTE 2 This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

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    31 pages
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ASTM
ASTM E2088-06(2021)(Practice)
Standard Practice for Selecting, Preparing, Exposing, and Analyzing Witness Surfaces for Measuring Particle Deposition in Cleanrooms and Associated Controlled Environments

SIGNIFICANCE AND USE
5.1 This practice provides a standard approach to measuring particle deposition, or fallout, in cleanrooms and other controlled environments. It is based on the use of a witness surface to collect particles that deposit from the surrounding environment and subsequently sizing and counting the particles by conventional methods. Several options are introduced, with limitations and guidelines for selecting the best choice for the intended application.  
5.2 This practice is applicable across numerous industries including aerospace, microelectronics, and pharmaceuticals.
SCOPE
1.1 This practice is intended to assist in the selection, preparation, exposure, and analysis of witness surfaces for the purpose of characterizing particle deposition rates in cleanrooms and associated controlled environments, particularly for aerospace applications.  
1.2 Requirements may be defined in terms of particle size distribution and count, percent area coverage, or product performance criteria such as optical transmission or scatter. Several choices for witness surfaces are provided.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM E2042/E2042M-09(2021)(Practice)
Standard Practice for Cleaning and Maintaining Controlled Areas and Clean Rooms

SIGNIFICANCE AND USE
4.1 This practice identifies methods for cleaning and maintaining controlled areas and clean rooms as defined by ISO 14644-1 and ISO 14644-2. Cleaning procedures are described, and cleaning frequency for different classes of facility are given. Compliance with this practice will make it easier and more likely that the required level of facility cleanliness will be maintained. A cleaner facility also will help to protect flight hardware from contamination and should reduce the frequency for cleaning flight hardware. This practice does not discuss operation and operational procedures for cleanrooms and controlled areas. Other documents such as IEST-RP-CC026 and Practice E2352 provide recommended practices for operating cleanrooms and controlled areas.
SCOPE
1.1 This practice covers the procedures to be followed for the initial cleaning and normal maintenance of cleanrooms and controlled areas. This practice is applicable to aerospace clean areas where both particles and molecular films (NVR) must be controlled.  
1.2 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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CEN
EN ISO 14644-17:2021(Main)
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
SIST EN ISO 14644-17:2021

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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SIST
SIST EN ISO 14644-17:2021(Main)
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)
EN ISO 14644-17:2021

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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CEN
EN 17141:2020(Main)
Cleanrooms and associated controlled environments - Biocontamination control
SIST EN 17141:2020

This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.
There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.

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

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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SIST
SIST EN 17141:2020(Main)
Cleanrooms and associated controlled environments - Biocontamination control
EN 17141:2020

This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.
This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.
There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.

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CEN
EN ISO 14644-3:2019(Main)
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
SIST EN ISO 14644-3:2020

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.
The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices.
NOTE       This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

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ASTM
ASTM E2614-15(2020)e1(Guide)
Standard Guide for Evaluation of Cleanroom Disinfectants

SIGNIFICANCE AND USE
5.1 Requirements for aseptic processing areas include readily cleanable floors, walls, and ceilings that have smooth, non-porous surfaces; particle, temperature, and humidity controls; and cleaning and disinfecting procedures to produce and maintain aseptic conditions. These controls, combined with careful and thorough evaluation of the chemical agents used for the cleaning and disinfection program, should lead to achieving the specified cleanliness standards and control of microbial contamination of products. Qualification of disinfectants in pharmaceutical, biotechnology, medical device facilities, and associated controlled environments, along with validation of the cleaning and disinfection process, is subject to scrutiny by regulatory agencies.  
5.2 An effective cleaning and disinfection program in aseptic processing areas of a Good Manufacturing Practice (GMP) - regulated facility is critical to assure product quality. Manufacturers are held to a high standard when it comes to product sterility, and regulatory agencies increasingly request validation data to support sanitization and disinfection procedures. Regulatory authorities expect evidence of the effectiveness of disinfection agents against environmental microorganisms isolated from the facility. The FDA Guideline for Aseptic Processing states, “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.”7  
5.3 Basic knowledge regarding the effectiveness of different chemical agents against vegetative bacteria, fungi, and spores will aid in selecting chemical agents.  
5.4 An understanding of test methods used to assess disinfectant effectiveness is important. Most methods are adaptable, allowing the user to customize the methods to their specific requirements.
SCOPE
1.1 This guide identifies important factors to consider when selecting a disinfectant for use in a cleanroom or similar controlled environment and recommends test methods suitable for evaluating disinfectants. The proper selection of disinfecting agent combined with qualification testing is a key element of a successful disinfection program. Regulatory guidance such as United States Pharmacopoeia Chapter , “Disinfectants and Antiseptics” and the FDA Guidance for Industry, “Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice” address the necessity of disinfectant effectiveness testing but do not clearly define acceptable test methods.  
1.2 An understanding of microbiology and microbiological techniques is essential. Knowledge in the following areas is recommended: microorganisms, antimicrobial products (disinfectants, sporicides, and decontamination agents), the chemistry of disinfection, mechanism of activity of disinfectants on cells, application procedures, cleanroom surfaces, and environmental conditions within a cleanroom. This information is available in several published texts listed in the bibliography.  
1.3 The theoretical basis for disinfectant activity is not addressed in this guide. An understanding of the effect of disinfectant concentration on microbial reduction (concentration exponent) and kinetics is desirable in determining the use-dilution of different disinfectants and in using dilution to neutralize a disinfectant for efficacy testing. USP chapter  provides further information on this topic.  
1.4 This guide is written for the cleanroom environment, although many of the principles outlined in this standard are applicable to manufacturing and processing environments outside of the cleanroom.  
1.5 Evaluation of disinfectants for biofilm control is outside the scope of this document.  
1.6 This international standard was developed in accordance with internationally recognized principles on standar...

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ASTM
ASTM E2090-12(2020)(Test Method)
Standard Test Method for Size-Differentiated Counting of Particles and Fibers Released from Cleanroom Wipers Using Optical and Scanning Electron Microscopy

SIGNIFICANCE AND USE
5.1 This test method provides for accurate and reproducible enumeration of particles and fibers released from a wiper immersed in a cleaning solution with moderate mechanical stress applied. When performed correctly, this counting test method is sensitive enough to quantify very low levels of total particle and fiber burden. The results are accurate and not influenced by artifact or particle size limitations. A further advantage to this technique is that it allows for morphological as well as X-ray analysis of individual particles.
SCOPE
1.1 This test method covers testing all wipers used in cleanrooms and other controlled environments for characteristics related to particulate cleanliness.  
1.2 This test method includes the use of computer-based image analysis and counting hardware and software for the counting of densely particle-laden filters (see 7.7 – 7.9). While the use of this equipment is not absolutely necessary, it is strongly recommended to enhance the accuracy, speed, and consistency of counting.  
1.3 The values stated in SI units are to be regarded as the standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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CEN
EN ISO 14644-16:2019(Main)
Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)
SIST EN ISO 14644-16:2019

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms.
This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications.
It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

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ASTM
ASTM E2217-12(2019)(Practice)
Standard Practice for Design and Construction of Aerospace Cleanrooms and Contamination Controlled Areas

SIGNIFICANCE AND USE
4.1 This practice describes and defines factors to be taken into consideration when designing and fabricating a cleanroom or controlled area that is used for aerospace operations and fabrication. Following the suggestions herein should provide a facility that is more capable of meeting performance requirements and that will offer protection against contamination for objects fabricated and processed in such a facility.
SCOPE
1.1 The purpose of this practice is to provide design and construction guidelines for contamination controlled facilities used in the assembly and integration of aerospace hardware. The guidelines herein are intended to ensure that the facilities, when used properly, will meet the cleanliness requirements of aerospace hardware and processes. The objective is to limit contamination due to the deposition of particulate and molecular contaminants on flight hardware surfaces.  
1.2 One cleanliness classification of a facility is the airborne particle concentrations in accordance with ISO 14644-1 and 14644-2. Airborne particle concentrations in accordance with FED-STD-209E are included for reference. This simple classification is inadequate to describe a facility that will support the assembly and integration of spacecraft. The extended duration of hardware exposure during fabrication and testing, the sensitivity of the hardware to hydrocarbons and other molecular contaminants, and the changing requirements during assembly and integration must be considered in addition to the airborne particle concentrations.  
1.3 The guidelines specified herein are intended to provide facilities that will effectively restrict contaminants from entering the facility, limit contamination generated by and within the facility, and continuously remove airborne contaminants generated during normal operations. Some items of support hardware, such as lifting equipment, stands, and shoe cleaners, are addressed since these items are often purchased and installed with the facility and may require accommodation in the design of the facility.  
1.4 Active filtration of molecular contaminants (such as hydrocarbons, silicones, and other chemicals) is discussed. Such active filtration of molecular contaminants may be required for the processing of highly sensitive optical devices, especially infrared and cryogenic sensors. Control of microbiological contamination is not included although HEPA (High Efficiency Particulate Air) filtration will provide some control of airborne bacteria, spores, and other viable contaminants that are typically carried on particles of sizes 0.3 μm and larger. Control of radioactive contamination and accommodation of very hazardous materials such as propellants, strong acids or caustics, or carcinogens are not addressed.  
1.5 No facility will compensate for excessive contamination generated inside the facility. In addition to an effective facility design, the user must also institute a routine maintenance program (see Practice E2042) for the facility, and personnel and operational disciplines that limit the transfer of contaminants through entry doors and contaminant generation inside the facility.  
1.6 This practice only addresses guidelines for contamination control in facility design. It must be implemented in compliance with all mandatory government and regulatory building and safety codes. References to related cleanroom standards and U.S. building codes and standards may be found in IEST-RP-CC012.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7.1 The values given in parentheses are provided for information only and are not considered standard.  
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and det...

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SIST
SIST EN ISO 14644-3:2020(Main)
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
EN ISO 14644-3:2019

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.
The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices.
NOTE       This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

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ISO
ISO 14644-3:2019(Main)
Cleanrooms and associated controlled environments - Part 3: Test methods

This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational. The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices. NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.

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SIST
SIST EN ISO 14644-16:2019(Main)
Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices (ISO 14644-16:2019)
EN ISO 14644-16:2019

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms.
This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications.
It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

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ASTM
ASTM E2312-11(2019)(Practice)
Standard Practice for Tests of Cleanroom Materials

SIGNIFICANCE AND USE
5.1 This practice is not intended to advocate or discourage use of any particular test method. It is intended for information only, and to provide a useful guide for further detailed study, test, and evaluation of cleanroom materials and products.
SCOPE
1.1 This practice identifies test methods used to evaluate the properties of various materials and products used in cleanrooms and for cleanroom construction.  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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    3 pages
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ISO
ISO 14644-16:2019(Main)
Cleanrooms and associated controlled environments - Part 16: Energy efficiency in cleanrooms and separative devices

This document gives guidance and recommendations for optimizing energy usage and maintaining energy efficiency in new and existing cleanrooms, clean zones and separative devices. It provides guidance for the design, construction, commissioning and operation of cleanrooms. This document covers all cleanroom-specific features and can be used in different areas to optimize energy use in electronic, aerospace, nuclear, pharmaceutical, hospital, medical device, food industries and other clean air applications. It also introduces the concept of benchmarking for the performance assessment and comparison of cleanroom energy efficiencies, while maintaining performance levels to ISO 14644 requirements[2][3].

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ASTM
ASTM E2352-19(Practice)
Standard Practice for Aerospace Cleanrooms and Associated Controlled Environments—Cleanroom Operations

ABSTRACT
This practice specifies the basic requirements, procedures, and practices for operating aerospace cleanrooms and controlled environments and the precautions associated with the facility and equipment used. This practice covers the requirements for operational systems, appropriate cleanroom clothing, authorized work personnel, stationary equipments, materials and mobile equipments, proper cleanroom operations, correct cleaning methods, and critical surfaces.
SCOPE
1.1 This practice specifies basic requirements, procedures, and practices for operating aerospace cleanrooms and controlled environments and precautions associated with the facility and equipment used.  
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ISO
ISO 14644-12:2018(Main)
Cleanrooms and associated controlled environments - Part 12: Specifications for monitoring air cleanliness by nanoscale particle concentration

This document covers the monitoring of air cleanliness by particles in terms of concentration of airborne nanoscale particles. For monitoring purposes, only populations of particles with a lower size limit of 0.1 microns (100 nm) or less ? "nanoscale" ? are considered. The monitoring given in this document is for use mainly in "operational" states. NOTE 1 For the purposes of this document, reference is made to "nanoscale particles", which means all nano-objects having one (nanoplate), two (nanofibre) or three (nanoparticle) dimensions in the nanoscale. NOTE 2 As a consequence, the specifications for monitoring air cleanliness by nanoscale particle concentration of the cleanroom in operational state also considers process specifics, e.g., used equipment, personnel behaviour, etc. NOTE 3 Health and safety considerations are excluded from this document.

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CEN
EN ISO 14644-15:2017(Main)
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
SIST EN ISO 14644-15:2018

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
-      health and safety requirements;
-      compatibility with cleaning agents and techniques;
-      cleanability;
-      biocontamination;
-      specific requirements of equipment and materials for processes and products;
-      design details of equipment.

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CEN
EN ISO 14644-13:2017(Main)
Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
SIST EN ISO 14644-13:2017

ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644‑9 and ISO 14644‑10.
The following matters of general guidance will be provided:
-      expected surface cleanliness levels;
-      suitability of cleaning methods;
-      compatibility of surfaces with the cleaning technique;
-      assessment of cleaning appropriateness.
The following will be excluded from this document:
-      classification of cleaning methods;
-      product produced within a cleanroom;
-      specific surface-related cleaning methods;
-      detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
-      detailed material characteristics;
-      description of damage mechanisms by cleaning processes and time-dependent effects;
-      references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent;
-      other characteristics of particles such as electrostatic charge, ionic charges, etc.;
-      chemical reactions between molecular contaminants and surfaces;
-      microbiological aspects of surface cleanliness;
-      radioactive aspects of contamination;
-      health and safety considerations;
-      environmental aspects such as waste disposal, emissions, etc.;
-      selection and use of statistical methods.

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SIST
SIST EN ISO 14644-15:2018(Main)
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
EN ISO 14644-15:2017

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
-      health and safety requirements;
-      compatibility with cleaning agents and techniques;
-      cleanability;
-      biocontamination;
-      specific requirements of equipment and materials for processes and products;
-      design details of equipment.

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ISO
ISO 14644-15:2017(Main)
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8). The following are outside the scope of ISO 14644-15:2017: - health and safety requirements; - compatibility with cleaning agents and techniques; - cleanability; - biocontamination; - specific requirements of equipment and materials for processes and products; - design details of equipment.

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SIST
SIST EN ISO 14644-13:2017(Main)
Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)
EN ISO 14644-13:2017

ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644‑9 and ISO 14644‑10.
The following matters of general guidance will be provided:
-      expected surface cleanliness levels;
-      suitability of cleaning methods;
-      compatibility of surfaces with the cleaning technique;
-      assessment of cleaning appropriateness.
The following will be excluded from this document:
-      classification of cleaning methods;
-      product produced within a cleanroom;
-      specific surface-related cleaning methods;
-      detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
-      detailed material characteristics;
-      description of damage mechanisms by cleaning processes and time-dependent effects;
-      references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent;
-      other characteristics of particles such as electrostatic charge, ionic charges, etc.;
-      chemical reactions between molecular contaminants and surfaces;
-      microbiological aspects of surface cleanliness;
-      radioactive aspects of contamination;
-      health and safety considerations;
-      environmental aspects such as waste disposal, emissions, etc.;
-      selection and use of statistical methods.

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ISO
ISO 14644-13:2017(Main)
Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications

ISO 14644-13:2017 gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces (external or internal) that are of interest. It provides guidance on the assessment of cleaning methods for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels. The appropriateness of cleaning techniques will make reference to the cleanliness classes and associated test methods found in ISO 14644‑9 and ISO 14644‑10. The following matters of general guidance will be provided: - expected surface cleanliness levels; - suitability of cleaning methods; - compatibility of surfaces with the cleaning technique; - assessment of cleaning appropriateness. The following will be excluded from this document: - classification of cleaning methods; - product produced within a cleanroom; - specific surface-related cleaning methods; - detailed description of cleaning mechanisms, methods and procedures of various cleaning methods; - detailed material characteristics; - description of damage mechanisms by cleaning processes and time-dependent effects; - references to interactive bonding forces between contaminants and surfaces or generation processes that are usually time-dependent and process-dependent; - other characteristics of particles such as electrostatic charge, ionic charges, etc.; - chemical reactions between molecular contaminants and surfaces; - microbiological aspects of surface cleanliness; - radioactive aspects of contamination; - health and safety considerations; - environmental aspects such as waste disposal, emissions, etc.; - selection and use of statistical methods.

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CEN
EN ISO 14644-14:2016(Main)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
SIST EN ISO 14644-14:2016

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE          Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
-      assessment of suitability with respect to biocontamination;
-      testing for suitability of decontamination agents and techniques;
-      cleanability of equipment and materials;
-      requirements on design of equipment and selection of materials;
-      physical properties of materials (e.g. electrostatic, thermal properties);
-      optimizing performance of equipment for specific process applications;
-      selection and use of statistical methods for testing;
-      protocols and requirements for local safety regulations.

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SIST
SIST EN ISO 14644-14:2016(Main)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
EN ISO 14644-14:2016

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE          Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
-      assessment of suitability with respect to biocontamination;
-      testing for suitability of decontamination agents and techniques;
-      cleanability of equipment and materials;
-      requirements on design of equipment and selection of materials;
-      physical properties of materials (e.g. electrostatic, thermal properties);
-      optimizing performance of equipment for specific process applications;
-      selection and use of statistical methods for testing;
-      protocols and requirements for local safety regulations.

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ISO
ISO 14644-14:2016(Main)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1). NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required. The following items are not covered by this ISO 14644-14:2016: - assessment of suitability with respect to biocontamination; - testing for suitability of decontamination agents and techniques; - cleanability of equipment and materials; - requirements on design of equipment and selection of materials; - physical properties of materials (e.g. electrostatic, thermal properties); - optimizing performance of equipment for specific process applications; - selection and use of statistical methods for testing; - protocols and requirements for local safety regulations.

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CEN
EN ISO 14644-1:2015(Main)
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
SIST EN ISO 14644-1:2016

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.
ISO 14644-1:2015 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm).
ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

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CEN
EN ISO 14644-2:2015(Main)
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
SIST EN ISO 14644-2:2016

ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.

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SIST EN ISO 14644-2:2016(Main)
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
EN ISO 14644-2:2015

ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.

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