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)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (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.
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO 14644-14:2016)
Dieser Teil von ISO 14644 legt eine Methodik zur Bewertung der Reinraumtauglichkeit von Geräten (z. B. Maschinen, Messgeräte, Prozessausrüstung, Komponenten und Werkzeuge) für die Anwendung in Reinräumen und zugehörigen kontrollierten Bereichen in Bezug auf die luftgetragene Partikelreinheit nach den Festlegungen in ISO 14644 1 fest. Der Partikelgrößenbereich reicht von 0,1 µm bis gleich oder größer als 5 µm (in ISO 14644 1 angegeben).
ANMERKUNG Sofern die zuständigen Behörden ergänzende Richtlinien oder Einschränkungen vorgeben, können geeignete Anpassungen der Methodik zur Bewertung erforderlich sein.
Die folgenden Aspekte sind nicht durch diesen Teil von ISO 14644 abgedeckt:
Bewertung der Tauglichkeit in Bezug auf die Biokontamination;
Prüfung zur Tauglichkeit von Dekontaminationsmitteln und -techniken;
Reinigungsfähigkeit der Geräte und Materialien;
Anforderungen an die konstruktive Auslegung von Geräten und die Auswahl von Materialien;
physikalische Materialeigenschaften (z. B. elektrostatische, thermische Eigenschaften);
Optimierung der Geräteleistung für spezifische Prozessanwendungen;
Auswahl und Anwendung statistischer Verfahren für die Prüfung;
Protokolle und Anforderungen hinsichtlich regionaler Sicherheitsvorschriften.
Salles propres et environnements maîtrisés apparentés - Partie 14: Évaluation de l'aptitude à l'emploi des équipements par la détermination de la concentration de particules en suspension dans l'air (ISO 14644-14:2016)
ISO 14644-14:2016 définit une méthodologie pour évaluer l'aptitude de l'équipement (par exemple, machines, équipements de mesure, équipements de procédé, composants, outils) à être employé dans les salles propres et les environnements maîtrisés apparentés, pour ce qui concerne la propreté particulaire de l'air telle que spécifiée dans l'ISO 14644‑1. La taille des particules varie de 0,1 µm à 5 µm ou plus (indiquée dans l'ISO 14644‑1).
NOTE Lorsque les instances réglementaires imposent des lignes directrices ou des restrictions supplémentaires, il peut s'avérer nécessaire d'adapter la méthodologie d'évaluation en conséquence.
Les éléments suivants ne sont pas traités dans l'ISO 14644-14:2016:
- l'évaluation de l'aptitude à l'emploi par rapport à la biocontamination;
- les essais d'aptitude à l'emploi des agents et des techniques de décontamination;
- la nettoyabilité des équipements et matériaux;
- les exigences relatives à la conception de l'équipement et à la sélection des matériaux;
- les propriétés physiques des matériaux (par exemple, propriétés électrostatiques, thermiques);
- l'optimisation des performances de l'équipement pour des applications de procédé particulières;
- la sélection et l'utilisation de méthodes statistiques pour les essais;
- les protocoles et exigences relatifs à la réglementation locale sur la sécurité.
Čisti prostori in z njimi povezana nadzorovana okolja - 14. del: Ocenjevanje primernosti uporabe opreme na podlagi koncentracije lebdečih delcev (ISO 14644-14:2016)
Ta del standarda ISO 14644 določa metodologijo za ocenjevanje primernosti opreme (npr. strojev, merilne opreme, procesne opreme, komponent in orodij) za uporabo v čistih sobah in podobnih nadzorovanih okoljih glede na čistost zraka na osnovi koncentracije lebdečih delcev, kot je določena v standardu ISO 14644-1.
Velikost delcev je v razponu od 0,1 μm do 5 μm ali več (razpon je podan v standardu ISO 14644-1).
OPOMBA: Če zakonodajni organi predpisujejo dodatne smernice ali omejitve, je metodologijo ocenjevanja morda treba ustrezno prilagoditi.
Naslednji elementi niso vključeni v ta del standarda ISO 14644:
– ocenjevanje primernosti glede na možnost biokontaminacije;
– preskušanje primernosti sredstev in tehnik za dekontaminacijo;
– možnost čiščenja opreme in materialov;
– zahteve za zasnovo opreme in izbiro materialov;
– fizične lastnosti materialov (npr. elektrostatične in toplotne lastnosti);
– optimizacija delovanja opreme za uporabo pri določenem postopku;
– izbira in uporaba statističnih metod za preskušanje;
– protokoli in zahteve za lokalne varnostne predpise.
General Information
Relations
Overview
EN ISO 14644-14:2016 (ISO 14644-14:2016) defines a standardized methodology to assess the suitability of equipment for use in cleanrooms and associated controlled environments with respect to airborne particle contamination. The standard links air cleanliness classification (as given in ISO 14644‑1) to equipment performance for particle sizes from 0.1 µm to ≥5 µm. It is intended to evaluate equipment such as machinery, process equipment, measuring devices, components, tools and furniture to determine whether they are compatible with a specified cleanroom class.
Key topics and requirements
- Assessment methodology: A structured procedure combining visual inspection and airborne particle concentration measurements to determine equipment suitability.
- Measurement scope: Particle counting across the ISO 14644‑1 size range (0.1 µm to ≥5 µm) and reference to the ISO 14644‑1 classification system.
- Test planning elements included in the standard:
- definition of a representative mode of operation
- specification of the test environment and its parameters
- identification of probable high particle concentration (HPC) locations, both approximate and precise
- execution of suitability measurements and subsequent data processing
- Documentation and reporting: Requirements for records of visual inspections, measurements, data processing and a formal statement on cleanroom suitability.
- Informative annexes: Examples for data processing and optional additional tests are provided to aid implementation.
- Exclusions: The standard does not cover biocontamination assessment, decontamination agent testing, cleanability, material design requirements, physical material properties (e.g., electrostatic), process optimization, selection of statistical methods, or local safety protocols.
Practical applications and users
ISO 14644-14 is used when introducing or qualifying equipment intended for use in contamination-sensitive environments. Typical practical uses:
- Pre‑purchase evaluation of equipment by cleanroom managers and procurement teams
- Qualification and acceptance testing during installation and validation by quality and validation engineers
- Risk assessment for introducing new tools or machines into classified clean zones
- Supporting change control and equipment maintenance activities
Who benefits:
- Cleanroom operators and facility managers
- Equipment manufacturers seeking cleanroom compatibility claims
- Validation/qualification engineers in pharmaceuticals, biotechnology, medical devices, microelectronics, optics, aerospace, food and healthcare industries
Related standards
- ISO 14644‑1:2015 - Classification of air cleanliness by particle concentration (normative reference)
- ISO 14644 series - other parts address test methods, monitoring, and additional cleanroom topics.
Keywords: ISO 14644-14, EN ISO 14644-14:2016, cleanrooms, airborne particle concentration, equipment suitability, ISO 14644-1, cleanroom validation, particle counting, cleanroom testing.
Frequently Asked Questions
EN ISO 14644-14:2016 is a standard published by the European Committee for Standardization (CEN). Its full title is "Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)". This standard covers: 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.
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.
EN ISO 14644-14:2016 is classified under the following ICS (International Classification for Standards) categories: 13.040.35 - Cleanrooms and associated controlled environments. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 14644-14:2016 has the following relationships with other standards: It is inter standard links to prEN ISO 14644-14. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase EN ISO 14644-14:2016 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO 2FHQMHYDQMHSULPHUQRVWL
XSRUDEHRSUHPHQDRVQRYLNRQFHQWUDFLMHOHEGHþLKGHOFHY ,62
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft ((ISO 14644-
14:2016)
Salles propres et environnements maîtrisés apparentés - Partie 14: Evaluation de la
compatibilité des équipments en termes d'émission particulaire pour une utilisation en
salle propre (ISO 14644-14:2016)
Ta slovenski standard je istoveten z: EN ISO 14644-14:2016
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 14644-14
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
14: Assessment of suitability for use of equipment by
airborne particle concentration (ISO 14644-14:2016)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 14: Évaluation de l'aptitude à l'emploi des 14: Bewertung der Reinraumtauglichkeit von Geräten
équipements par la détermination de la concentration durch Partikelkonzentration in der Luft (ISO 14644-
de particules en suspension dans l'air (ISO 14644- 14:2016)
14:2016)
This European Standard was approved by CEN on 13 August 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-14:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-14:2016) has been prepared by Technical Committee ISO/TC 209
“Cleanrooms and associated controlled environments” in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-14
First edition
2016-09-15
Cleanrooms and associated controlled
environments —
Part 14:
Assessment of suitability for use
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l’aptitude à l’emploi des équipements par
la détermination de la concentration de particules en suspension
dans l’air
Reference number
ISO 14644-14:2016(E)
©
ISO 2016
ISO 14644-14:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General outline of the assessment . 3
5 Visual inspection . 3
6 Assessment of suitability by airborne particle concentration measurements .4
6.1 General . 4
6.2 Assessment procedure . 4
6.2.1 Overview . 4
6.2.2 Requirements and considerations . 5
6.2.3 Representative mode of operation . 6
6.2.4 Considerations for the test environment . 6
6.2.5 Determination of the test environment . 6
6.2.6 Approximate identification of HPC location(s) . 6
6.2.7 Precise determination of HPC location(s) . 7
6.2.8 Suitability measurement(s) . 7
6.2.9 Data processing . 8
6.2.10 Reference to ISO 14644‑1 classification system .10
7 Documentation .10
7.1 General .10
7.2 Common documentation requirements .10
7.3 Documentation for visual inspection .11
7.4 Documentation for assessment of test environment .11
7.5 Documentation for classification measurement .12
8 Statement on cleanroom suitability .12
Annex A (informative) Example for data processing deriving from measurements .14
Annex B (informative) Additional optional tests .18
Bibliography .21
ISO 14644-14:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all part in the ISO 14644 series, published under the general title Cleanrooms and associated
controlled environments, can be found on the ISO website.
iv © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination‑sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).
This part of ISO 14644 links the cleanroom classification of air cleanliness by particle concentration to
the suitability of equipment for use in cleanrooms and associated controlled environments.
INTERNATIONAL STANDARD ISO 14644-14:2016(E)
Cleanrooms and associated controlled environments —
Part 14:
Assessment of suitability for use of equipment by airborne
particle concentration
1 Scope
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness by particle concentration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleanliness
condition not exceeding a specified level of contamination
ISO 14644-14:2016(E)
3.2
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.3
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone when used as intended
Note 1 to entry: For the purposes of this part of ISO 14644, the assessment is based on airborne particle
concentration.
3.4
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.5
decontamination
reduction of unwanted matter to a defined level
[SOURCE: ISO 14644-7:2004, 3.7]
3.6
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE Testing and manufacturing equipment and machinery, equipment for transport and handling,
storage units, tools, furniture, doors, ceilings, Information Technology (IT) hardware and handling robots.
3.7
test environment
space in which the test is carried out, described by a set of parameters
2 © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
4 General outline of the assessment
Cleanroom suitability assessment has the following outline.
a) Before the assessment can be executed, the customer and supplier shall agree upon the particle
size range(s), with reference to air cleanliness by particle concentration, designated by ISO Class
N as given in ISO 14644-1 and item to be tested including the modes of operation(s). Each selected
mode of operation shall be assessed separately.
b) A short description regarding how the equipment will be used in routine operation (with operating
parameters) shall be given to promote setting the appropriate testing condition and parameters.
c) Visual inspection (see Clause 5).
d) The procedure described in Clause 6 shall be used in order to establish a link to the ISO 14644-1
classification system.
e) Execution of measurements (see 6.2).
f) The data gathered will be processed and the results linked to the ISO classification system (see
6.2.9 and 6.2.10).
g) The results obtained shall conclude the equipment’s cleanroom suitability; the statement shall
follow the defined designation (see Clause 8).
Additional optional tests (not linked to ISO class N), such as total emission of particles or operational
life cycle test, are described in Annex B.
The method described in B.4 may be used to determine the average total emission of equipment and
provides data that may be used to determine the particle load on a cleanroom.
5 Visual inspection
Visual inspection of the equipment shall be carried out before and after any measurement‑based
assessment.
The visual inspection shall ensure that all packaging has been removed and that the equipment is
undamaged and that it is correctly assembled and appropriately connected to its required utilities.
Visual surface cleanliness shall be qualitatively assessed such that any subsequent quantifiable tests
shall not be compromised. This part of the visual inspection can include assessment for particles,
surface films or inappropriately located lubricants.
The objectives of this inspection are the following:
— identify contamination, such as particles and films originated from manufacturing, packaging,
transportation or initial assembly;
— identify contamination that has withstood any prior decontamination process.
It is not intended that this inspection will provide a measurement of surface cleanliness.
Depending on the location of the contamination, the results from visual inspection shall be
— recorded and available for comparison with the post-test visual inspection of surface cleanliness, and
— used as basis to direct a repeat or improved decontamination process.
Detection efficiency of visible contamination on equipment will depend upon the following factors:
— the accessibility and orientation of the surface to be inspected;
ISO 14644-14:2016(E)
— the materials used for equipment construction, their surface condition and treatment;
— the viewing parameters (e.g. illumination, field of view, vision magnification, viewing distance).
6 Assessment of suitability by airborne particle concentration measurements
6.1 General
The objective of Clause 6 is to describe a suitability methodology using measurement of airborne
particle emissions at critical locations. By including measurement locations at, or close to, the locations
of high particle concentration (HPC), the intended use of the application is reflected.
This assessment methodology enables a link to the classification system of ISO 14644‑1, in one or more
particle size ranges to be established.
In order to assess the cleanroom suitability of equipment, it is intended that the location(s) with HPC
emitted by the equipment be identified and included in the final suitability measurement. Since the size
distribution of the emitted particles is not known in advance, it is required that more than one particle
size range is measured. Ideally, three widely spread particle size ranges should be selected.
Subsequently, the particle concentrations thus determined from equipment assessment are compared
with the air cleanliness by particle concentration limits for ISO Class N as specified in ISO 14644‑1.
For the equipment to be tested, it shall be ensured that cleanroom compliant design principles have
been incorporated. These principles include, but are not limited to, the following:
— selection of appropriate materials and surface finishes;
— avoidance of static air zones;
— design principles for cleanability;
— considerations for maintenance.
This measurement methodology is not intended to determine overall emission rates for the equipment
under test.
6.2 Assessment procedure
6.2.1 Overview
The flowchart in Figure 1 gives an overview of the necessary assessment steps.
4 © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Figure 1 — Overview of the assessment procedure
6.2.2 Requirements and considerations
When defining the scope of the suitability assessment, aspects that could influence the assessment
results shall be considered, for example (but not limited to):
— variability between the same type of equipment;
— pre‑conditioning of the equipment to be tested (accumulated operating hours);
— running-in of equipment.
ISO 14644-14:2016(E)
The test environment shall be agreed upon before testing (see 6.2.4 and 6.2.5).
6.2.3 Representative mode of operation
A representative mode of operation of equipment shall be defined, which ensures that particle emission
sources are detected. The mode of operation shall reflect the intended use of the equipment. If the
equipment can be operated in different modes of operation (e.g. with or without product), it shall be
decided which of these different modes form part of the assessment. Equipment parameters of operation
shall be defined and agreed upon before testing.
If standardized procedures exist, these procedures shall be taken into consideration. For non-
standardized handling, the manner of handling chosen shall be documented, and reasons for this choice
shall be given.
6.2.4 Considerations for the test environment
The objective of these tests is to characterize and select a test environment prior to installing the
equipment that is to undergo assessment for cleanroom suitability.
Consideration should be given to whether all or some pre-tests are conducted at more than one
measuring plane. An illustration of selected measurement plane(s) may be added.
Information on measurement test methods and equipment can be obtained from ISO 14644-1 and
ISO 14644-3. The following shall be considered.
— Airborne particle concentration measurement: The aim is to confirm that the test environment is
at least one ISO class N (as given in ISO 14644-1) cleaner than the cleanroom or clean zone within
which the equipment is intended to be used.
— Airflow velocity measurement: Guidance range for vertical velocity should be in the range of 0,3 m/s
to 0,5 m/s.
— Temperature: Guidance range should be 18 °C to 25 °C.
— Humidity: Guidance range should be 30 % RH to 70 % RH.
Additional informative pre-tests can include the following:
— airflow direction test and visualization;
— electrostatic and ion generator test;
— particle deposition test.
The results of the considerations shall be used for the determination of the test environment (see 6.2.5).
6.2.5 Determination of the test environment
The test environment shall provide a background level at least one ISO Class N (as given in ISO 14644-1)
cleaner than the cleanroom or clean zone in which the equipment is intended to be used.
NOTE Testing of equipment for ISO Class 1 suitability is accomplished in an ISO Class 1 environment.
The test environment shall not contain any other particle sources than the equipment to be assessed to
avoid influencing the measure
...
SLOVENSKI STANDARD
01-december-2016
Čisti prostori in z njimi povezana nadzorovana okolja - 14. del: Ocenjevanje
primernosti uporabe opreme na podlagi koncentracije lebdečih delcev (ISO 14644-
14:2016)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft ((ISO 14644-
14:2016)
Salles propres et environnements maîtrisés apparentés - Partie 14: Evaluation de la
compatibilité des équipments en termes d'émission particulaire pour une utilisation en
salle propre (ISO 14644-14:2016)
Ta slovenski standard je istoveten z: EN ISO 14644-14:2016
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 14644-14
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
14: Assessment of suitability for use of equipment by
airborne particle concentration (ISO 14644-14:2016)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 14: Évaluation de l'aptitude à l'emploi des 14: Bewertung der Reinraumtauglichkeit von Geräten
équipements par la détermination de la concentration durch Partikelkonzentration in der Luft (ISO 14644-
de particules en suspension dans l'air (ISO 14644- 14:2016)
14:2016)
This European Standard was approved by CEN on 13 August 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-14:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-14:2016) has been prepared by Technical Committee ISO/TC 209
“Cleanrooms and associated controlled environments” in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-14
First edition
2016-09-15
Cleanrooms and associated controlled
environments —
Part 14:
Assessment of suitability for use
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l’aptitude à l’emploi des équipements par
la détermination de la concentration de particules en suspension
dans l’air
Reference number
ISO 14644-14:2016(E)
©
ISO 2016
ISO 14644-14:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General outline of the assessment . 3
5 Visual inspection . 3
6 Assessment of suitability by airborne particle concentration measurements .4
6.1 General . 4
6.2 Assessment procedure . 4
6.2.1 Overview . 4
6.2.2 Requirements and considerations . 5
6.2.3 Representative mode of operation . 6
6.2.4 Considerations for the test environment . 6
6.2.5 Determination of the test environment . 6
6.2.6 Approximate identification of HPC location(s) . 6
6.2.7 Precise determination of HPC location(s) . 7
6.2.8 Suitability measurement(s) . 7
6.2.9 Data processing . 8
6.2.10 Reference to ISO 14644‑1 classification system .10
7 Documentation .10
7.1 General .10
7.2 Common documentation requirements .10
7.3 Documentation for visual inspection .11
7.4 Documentation for assessment of test environment .11
7.5 Documentation for classification measurement .12
8 Statement on cleanroom suitability .12
Annex A (informative) Example for data processing deriving from measurements .14
Annex B (informative) Additional optional tests .18
Bibliography .21
ISO 14644-14:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all part in the ISO 14644 series, published under the general title Cleanrooms and associated
controlled environments, can be found on the ISO website.
iv © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination‑sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).
This part of ISO 14644 links the cleanroom classification of air cleanliness by particle concentration to
the suitability of equipment for use in cleanrooms and associated controlled environments.
INTERNATIONAL STANDARD ISO 14644-14:2016(E)
Cleanrooms and associated controlled environments —
Part 14:
Assessment of suitability for use of equipment by airborne
particle concentration
1 Scope
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness by particle concentration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
cleanliness
condition not exceeding a specified level of contamination
ISO 14644-14:2016(E)
3.2
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.3
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone when used as intended
Note 1 to entry: For the purposes of this part of ISO 14644, the assessment is based on airborne particle
concentration.
3.4
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.5
decontamination
reduction of unwanted matter to a defined level
[SOURCE: ISO 14644-7:2004, 3.7]
3.6
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE Testing and manufacturing equipment and machinery, equipment for transport and handling,
storage units, tools, furniture, doors, ceilings, Information Technology (IT) hardware and handling robots.
3.7
test environment
space in which the test is carried out, described by a set of parameters
2 © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
4 General outline of the assessment
Cleanroom suitability assessment has the following outline.
a) Before the assessment can be executed, the customer and supplier shall agree upon the particle
size range(s), with reference to air cleanliness by particle concentration, designated by ISO Class
N as given in ISO 14644-1 and item to be tested including the modes of operation(s). Each selected
mode of operation shall be assessed separately.
b) A short description regarding how the equipment will be used in routine operation (with operating
parameters) shall be given to promote setting the appropriate testing condition and parameters.
c) Visual inspection (see Clause 5).
d) The procedure described in Clause 6 shall be used in order to establish a link to the ISO 14644-1
classification system.
e) Execution of measurements (see 6.2).
f) The data gathered will be processed and the results linked to the ISO classification system (see
6.2.9 and 6.2.10).
g) The results obtained shall conclude the equipment’s cleanroom suitability; the statement shall
follow the defined designation (see Clause 8).
Additional optional tests (not linked to ISO class N), such as total emission of particles or operational
life cycle test, are described in Annex B.
The method described in B.4 may be used to determine the average total emission of equipment and
provides data that may be used to determine the particle load on a cleanroom.
5 Visual inspection
Visual inspection of the equipment shall be carried out before and after any measurement‑based
assessment.
The visual inspection shall ensure that all packaging has been removed and that the equipment is
undamaged and that it is correctly assembled and appropriately connected to its required utilities.
Visual surface cleanliness shall be qualitatively assessed such that any subsequent quantifiable tests
shall not be compromised. This part of the visual inspection can include assessment for particles,
surface films or inappropriately located lubricants.
The objectives of this inspection are the following:
— identify contamination, such as particles and films originated from manufacturing, packaging,
transportation or initial assembly;
— identify contamination that has withstood any prior decontamination process.
It is not intended that this inspection will provide a measurement of surface cleanliness.
Depending on the location of the contamination, the results from visual inspection shall be
— recorded and available for comparison with the post-test visual inspection of surface cleanliness, and
— used as basis to direct a repeat or improved decontamination process.
Detection efficiency of visible contamination on equipment will depend upon the following factors:
— the accessibility and orientation of the surface to be inspected;
ISO 14644-14:2016(E)
— the materials used for equipment construction, their surface condition and treatment;
— the viewing parameters (e.g. illumination, field of view, vision magnification, viewing distance).
6 Assessment of suitability by airborne particle concentration measurements
6.1 General
The objective of Clause 6 is to describe a suitability methodology using measurement of airborne
particle emissions at critical locations. By including measurement locations at, or close to, the locations
of high particle concentration (HPC), the intended use of the application is reflected.
This assessment methodology enables a link to the classification system of ISO 14644‑1, in one or more
particle size ranges to be established.
In order to assess the cleanroom suitability of equipment, it is intended that the location(s) with HPC
emitted by the equipment be identified and included in the final suitability measurement. Since the size
distribution of the emitted particles is not known in advance, it is required that more than one particle
size range is measured. Ideally, three widely spread particle size ranges should be selected.
Subsequently, the particle concentrations thus determined from equipment assessment are compared
with the air cleanliness by particle concentration limits for ISO Class N as specified in ISO 14644‑1.
For the equipment to be tested, it shall be ensured that cleanroom compliant design principles have
been incorporated. These principles include, but are not limited to, the following:
— selection of appropriate materials and surface finishes;
— avoidance of static air zones;
— design principles for cleanability;
— considerations for maintenance.
This measurement methodology is not intended to determine overall emission rates for the equipment
under test.
6.2 Assessment procedure
6.2.1 Overview
The flowchart in Figure 1 gives an overview of the necessary assessment steps.
4 © ISO 2016 – All rights reserved
ISO 14644-14:2016(E)
Figure 1 — Overview of the assessment procedure
6.2.2 Requirements and considerations
When defining the scope of the suitability assessment, aspects that could influence the assessment
results shall be considered, for example (but not limited to):
— variability between the same type of equipment;
— pre‑conditioning of the equipment to be tested (accumulated operating hours);
— running-in of equipment.
ISO 14644-14:2016(E)
The test environment shall be agreed upon before testing (see 6.2.4 and 6.2.5).
6.2.3 Representative mode of operation
A representative mode of operation of equipment shall be defined, which ensures that particle emission
sources are detected. The mode of operation shall reflect the intended use of the equipment. If the
equipment can be operated in different modes of operation (e.g. with or without product), it shall be
decided which of these different modes form part of the assessment. Equipment parameters of operation
shall be defined and agreed upon before testing.
If standardized procedures exist, these procedures shall be taken into consideration. For non-
standardized handling, the manner of handling chosen shall be documented, and reasons for this choice
shall be given.
6.2.4 Considerations for the test environment
The objective of these tests is to characterize and select a test environment prior to installing the
equipment that is to undergo assessment for cleanroom suitability.
Consideration should be given to whether all or some pre-tests are conducted at more than one
measuring plane. An illustration of selected measurement plane(s) may be added.
Information on measurement test methods and equipment can be obtained from ISO 14644-1 and
ISO 14644-3. The following shall be considered.
— Airborne particle concentration measurement: The aim is to confirm that the test environment is
at least one ISO class N (as given in ISO 14644-1) cleaner than the cleanroom or clean zone within
which the equipment is intended to be used.
— Airflow velocity measurement: Guidance range for vertical velocity should be in the range of 0,3 m/s
to 0,5 m/s.
— Temperature: Guidance range should be 18 °C to 25 °C.
— Humidity: Guidance range should be 30 % RH to 70 % RH.
Additional informative pre-tests can include the following:
— airflow direction test and visualization;
— electrostatic and ion generator test;
— particle deposition test.
The results of the considerations shall be used for the determination of the test environment (see 6.2.5).
6.2.5 Determination of the test environment
The test environment shall provide a background level at least one ISO Class N (as given in ISO 14644-1)
cleaner than the cleanroom or clean zone in which the equipment is intended to be used.
NOTE Testing of equipment for ISO Class 1 suitability is accomplished in an ISO Class 1 environment.
The test environment shall not contain any other particle sources than the equipment to be assessed to
avoid influencing the
...
記事タイトル：EN ISO 14644-14:2016 - クリーンルームおよび関連する制御環境 - 第14部: 空気中の粒子濃度による装置の適合性評価（ISO 14644-14:2016） 記事内容: ISO 14644-14:2016は、クリーンルームおよび関連する制御環境で使用する装置（例：機械、計測装置、プロセス装置、部品、ツール）の空気中の粒子のクリーンリネスに関する適合性を評価するための手法を規定しています。粒子のサイズは、ISO 14644-1で指定されている0.1µmから5µm以上までの範囲をカバーしています。 注：規制機関が追加のガイドラインや制限を課す場合、適応した適合性評価手法が必要になる場合があります。 以下の項目は、ISO 14644-14:2016ではカバーされていません： - バイオコンタミネーションに関する適合性評価 - 脱汚染剤や技術の適合性テスト - 装置および材料の清掃可能性 - 装置の設計要件および材料の選択 - 材料の物理的特性（静電気、熱特性など） - 特定のプロセスアプリケーションに向けた装置のパフォーマンス最適化 - テストのための統計的手法の選択と使用 - 現地の安全規制に関するプロトコルと要件
ISO 14644-14:2016 provides a methodology for evaluating the suitability of equipment to be used in cleanrooms and controlled environments. It focuses on assessing airborne particle cleanliness. The standard covers particle sizes ranging from 0.1 µm to 5 µm or larger. However, it does not cover biocontamination assessment, testing decontaminants, cleanability of equipment and materials, design requirements, material properties, performance optimization, statistical testing methods, and local safety regulations. Adaptation of the assessment methodology may be required if regulatory agencies impose additional guidelines or restrictions.
The article discusses the ISO 14644-14:2016 standard, which outlines a methodology for assessing the suitability of equipment in cleanrooms and controlled environments. The standard focuses on airborne particle cleanliness and covers particle sizes ranging from 0.1 µm to 5 µm. However, it does not cover assessments related to biocontamination, testing of decontamination agents, cleanability of equipment, design requirements, physical properties of materials, performance optimization, statistical methods, and local safety regulations. Adaptations may be necessary if regulatory agencies impose additional guidelines or restrictions.
記事タイトル：EN ISO 14644-14:2016-クリーンルームおよび関連する制御環境-第14部：空気中の粒子濃度による機器の適用性評価（ISO 14644-14:2016） 記事内容：ISO 14644-14:2016は、クリーンルームおよび関連する制御環境での機器（例：機械、計測機器、プロセス機器、コンポーネント、ツールなど）の適用性を評価するための手法を規定しています。ISO 14644-1で指定された空気中の粒子の清浄度に関連します。粒子のサイズは0.1µmからISO 14644-1で示されている5µm以上まで範囲があります。 注意：規制当局が追加のガイドラインや制限を課す場合、適用性評価の方法論の適応が必要とされることがあります。 以下の項目は、このISO 14644-14:2016ではカバーされていません： - 生物汚染に関する適用性評価 - 消毒剤や技術の適用性のテスト - 機器や材料の清掃性 - 機器の設計要件や材料の選択に関する要件 - 材料の物理的特性（静電気、熱特性など） - 特定のプロセスアプリケーションに対する機器性能の最適化 - テストのための統計的な方法やその選択および使用 - ローカルの安全規制のプロトコルと要件
기사 제목: EN ISO 14644-14:2016 - 청정실 및 관련 제어 환경 - 제14편: 공기 중 입자 농도에 따른 장비 적합성 평가 (ISO 14644-14:2016) 기사 내용: ISO 14644-14:2016은 청정실 및 관련 제어 환경에서 사용할 장비(예: 기계, 측정 장비, 공정 장비, 구성 요소 및 도구)의 공기 중 입자 깨끗함에 대한 적합성을 평가하는 방법론을 명시한다. 입자 크기는 ISO 14644-1에 명시된 바와 같이 0.1 µm에서 5 µm 이상까지 범위가 있다. 주의: 규정 기관이 추가적인 지침이나 제한을 부과하는 경우, 평가 방법론의 적절한 수정이 필요할 수 있다. 다음 항목은 ISO 14644-14:2016에서 다루지 않는다: - 생물오염에 대한 적합성 평가 - 탈오염제와 기술의 적합성 검사 - 장비와 재료의 세정성 - 장비 설계 및 재료 선택 요구사항 - 재료의 물리적 특성 (정전기, 열적 특성 등) - 특정 공정 응용을 위한 장비 성능 최적화 - 통계적 방법을 위한 선택 및 사용 - 현지 안전 규정에 대한 프로토콜 및 요구사항
기사 제목: EN ISO 14644-14:2016-청정실 및 관련 조절 환경-제14부: 공기 중 입자 농도에 따른 장비 사용 적합성 평가 (ISO 14644-14:2016) 기사 내용: ISO 14644-14:2016은 기계, 측정 장비, 공정 장비, 구성 요소 및 도구 등 청정실 및 관련 조절 환경에서의 사용 적합성을 평가하기 위한 방법론을 규정한다. 이는 ISO 14644-1에서 규정한 공기 중 입자의 청결도에 관련된 사항이다. 입자 크기는 0.1 µm에서 ISO 14644-1에서 명시된 것과 같거나 큰 5 µm까지이다. 참고: 규제 기관이 추가 가이드라인이나 제한 사항을 부과하는 경우, 적절한 평가 방법론의 적응이 필요할 수 있다. 다음 항목은 ISO 14644-14:2016에서 다루지 않는다: - 생물 오염에 대한 적합성 평가; - 탈염제 및 기법에 대한 적합성 테스트; - 장비와 재료의 세정 기능; - 장비의 설계 요구 사항 및 재료 선택; - 재료의 물리적 특성 (예: 정전기, 열 특성); - 특정 공정 응용을 위한 장비 성능 최적화; - 테스트를 위한 통계적 방법과 그 선택 및 사용; - 로컬 안전 규정의 프로토콜과 요구 사항.
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