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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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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This European Standard establishes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments. These principles are based on establishing control and then on demonstrating control.
This standard specifies the methods required for assessing risk monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved.
It will also give guidance on the assessment and verification of microbiological sampling devices, with the aim of helping users standardize their monitoring so that results from one facility to another can be compared.
Within this standard, only microbiological hazards are addressed.
There is specific guidance given on common applications, including Food, Hospitals and Life Sciences (Pharma/Biopharma and Medical Devices).

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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.

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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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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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This standard gives recommendations on reducing energy consumption and maintaining energy efficiency in new and existing cleanrooms and clean air devices, as classified by EN ISO 14644-1.

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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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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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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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This document 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 this document:
— 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 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 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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This part of ISO 14644 addresses the cleaning (removal of contaminants) to a specified degree on cleanroom surfaces, surfaces of equipment in the cleanroom and surfaces of materials in the cleanroom.
The following are excluded from this document:
• product and process cleaning;
• cleaning of microbiological contamination;
• detailed cleaning methods and procedures.
This part of ISO 14644 provides guidance about different cleaning techniques, classified, e.g. as wet/dry and physical/chemical.
This part of ISO 14644 provides guidance on which methods should be used for achieving 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 efficacy of cleaning techniques makes reference to the cleanliness classes and associated test methods found in ISO 14644-8, -9 and -10.
The following matters of general guidance are provided:
• assessment of adverse effects such as health and safety considerations,
surface/material properties;
• compatability of surfaces with the cleaning technique,
• surface attributes such as morphology;
• configurations such as crevices, holes and cracks,
• waste and effluent
• suitability of cleaning agents and materials (e.g. purity, cleanliness, properties)

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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 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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This part of ISO 14644 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 part of ISO 14644:
— 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 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 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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This part of ISO 14644 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.
This part of ISO 14644 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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This Part of this European Standard specifies the classification of particulate cleanliness for cleanrooms and clean air controlled spaces in three possible occupancy states according to the number concentration of airborne particulate matter present.

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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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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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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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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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This standard establishes the principles and basic methodology for microbiological control of cleanrooms and associated controlled environments with planetary protection constraints.
This standard does not address:
•   the microbiological contamination control of  spaceflight hardware;
•   molecular contamination control. Reference is made to other documents;
•   fire and safety regulations; for these, see regulatory requirements and other national or local documentation.
This standard does not lay down the methods for determining the microbiological and particulate cleanliness levels. Reference is made to other documents.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.

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This standard defines the requirements and guidelines for the measurement of particulate contamination on the surfaces of spacecraft systems and those of the cleanrooms or other cleanliness controlled areas in which they reside.
This includes the measurement of particulate contamination that is present on the spacecraft or cleanroom surfaces via the use of representative witness samples placed in the vicinity of the spacecraft hardware, the direct measurement of particulate contamination
levels on surfaces of spacecraft hardware from the direct surface transfer to adhesive tape-lift samples and particulate contaminant levels within fluids used for the cleaning or rinsing of such spacecraft system components and cleanroom surfaces. This standard also defines the methods to be used for the visual inspection of spacecraft system hardware for particulate contamination.
The measurement of airborne particulate contamination is not covered in this standard and ISO 14644 “Cleanrooms and associated
controlled environments” is applicable in this case.
This standard does not cover particulate contamination monitoring for spacecraft propulsion hardware which is covered in ECSS-E-ST-35-06.
This standard may be tailored for the specific characteristic and constrains of a space project in conformance with ECSS-S-ST-00.

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This part of ISO 14644 covers the classification 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 within the specification for classification. This part of ISO 14644 currently considers only concentrations of air chemical contaminants between 100 and 10-12 g/m3 under cleanroom operational conditions. This part of ISO 14644 is not relevant for application in those industries, processes or production where the presence of airborne chemical substances is not considered a risk to the product or process. It is not the intention of this part of ISO 14644 to describe the nature of air chemical contaminants. This part of ISO 14644 does not give a classification of surface chemical contamination.

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This part of ISO 14644 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This part of ISO 14644 is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices. NOTE 1 For the purpose of this part of ISO 14644, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this part of ISO 14644 does not cover the interaction between the contamination and the surface. NOTE 2 This part of ISO 14644 does not include the contamination generation process and any time-dependent influences (deposition, sedimentation, ageing, etc.) 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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ISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices.

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ISO 14644-10:2012 defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). It is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environment, tools, equipment and devices.

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ISO 14644-8:2013 establishes the classification 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 within the specification for classification.
ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2013 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 ISO 14644-8:2013 to describe the nature of air chemical contaminants.
ISO 14644-8:2013 does not give a classification of surface chemical contamination.

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ISO 14644-8:2013 establishes the classification 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 within the specification for classification. ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions. ISO 14644-8:2013 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 ISO 14644-8:2013 to describe the nature of air chemical contaminants. ISO 14644-8:2013 does not give a classification of surface chemical contamination.

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This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particle concentration 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 part of ISO 14644 applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The classification of surface cleanliness by particle concentration (SCP) is limited to particles between 0,05 μm and 500 μm. The following issues are not considered in this part of ISO 14644: - 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 classification and testing; - other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

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ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given
ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm.
The following issues are not considered:
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 classification and testing;
other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

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ISO 14644-9:2012 establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics are also given ISO 14644-9:2012 applies to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, working environments, tools, equipment and products. The surface particle cleanliness (SPC) classification is limited to particles between 0,05 µm and 500 µm. The following issues are not considered: 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 classification and testing; other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc.

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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 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5.
The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
ISO 14644-7:2004 is not applicable to full-suits.

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ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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ISO 14644-7:2004 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as described in ISO 14644-4 and 14644-5. The application of ISO 14644-7:2004 takes into account the following limitations: user requirements are as agreed by customer and supplier; application-specific requirements are not addressed; specific processes to be accommodated in the separative-device installation are not specified; fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply. ISO 14644-7:2004 is not applicable to full-suits.

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ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

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ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. In zones where risk is low, it can be used for information.

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ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1.

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Migrated from Progress Sheet (TC Comment) (2000-07-10): This WI is the result of the merging of WIs 2, 5-8 (TC Res 39/1997)
!!! To be submitted to a 2nd // DIS/CEN Enq - Waiting for TC 243 resolution (NT/2001-11-13) !!!

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