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 l...
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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...view more

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    • Standard
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    • Standard
      27 pages
      French language
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      26 pages
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    • Draft
      27 pages
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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 verifi...
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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 determi...view more

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    • Standard
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    • Standard
      61 pages
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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 deter...
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    • Standard
      61 pages
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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 determi...view more

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    • Standard
      52 pages
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    • Standard
      53 pages
      English language
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    • Standard
      58 pages
      French language
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    • Standard
      59 pages
      French language

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 a...
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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 app...view more

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    • Standard
      43 pages
      English language
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    • Standard
      46 pages
      French language

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 (nanof...view more

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      11 pages
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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;
...
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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;
- biocontaminat...
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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; ...view more

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    • Standard
      21 pages
      English language
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    • Standard
      22 pages
      French language

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.
Thi...
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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...view more

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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...view more

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    • Standard
      34 pages
      English language
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    • Standard
      36 pages
      French language

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
o...
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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 ass...
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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 asse...view more

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    • Standard
      21 pages
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    • Standard
      21 pages
      English language
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    • Standard
      21 pages
      French language
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    • Standard
      21 pages
      French language

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 ...
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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 ra...
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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 ...
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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...view more

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    • Standard
      37 pages
      English language
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    • Standard
      37 pages
      English language
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    • Standard
      37 pages
      English language
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    • Standard
      39 pages
      French language
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    • Standard
      39 pages
      French language

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 ran...view more

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    • Standard
      14 pages
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    • Standard
      14 pages
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    • Standard
      14 pages
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    • Standard
      14 pages
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    • Standard
      14 pages
      French language

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 do...
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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 ...
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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...view more

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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...view more

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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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    • Standard
      30 pages
      English language
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    • Standard
      30 pages
      French language

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 opera...
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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 operat...view more

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    • Standard
      22 pages
      English language
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    • Standard
      22 pages
      French language

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 an...view more

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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 par...
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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 part...view more

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    • Standard
      26 pages
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    • Standard
      29 pages
      French language

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 Pharmaceut...
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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 ...
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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 i...view more

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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 a...view more

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    • Standard
      52 pages
      English language
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    • Standard
      52 pages
      French language

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 i...view more

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    • Standard
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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 i...view more

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    • Standard
      44 pages
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    • Standard
      49 pages
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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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    • Standard
      11 pages
      English language
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    • Standard
      11 pages
      French language

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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    • Standard
      32 pages
      English language
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    • Standard
      35 pages
      French language
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    • Standard
      51 pages
      English language
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    • Standard
      51 pages
      French language

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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