SIST EN ISO 14644-14:2016
(Main)Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)
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.
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: Evaluation de la compatibilité des équipments en termes d'émission particulaire pour une utilisation en salle propre (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
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14644-14:2016
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
SIST EN ISO 14644-14:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14644-14:2016
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
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.
3
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SIST EN ISO 14644-14:2016
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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;
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
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 measurement results. This can be achieved using unidirectional airflow.
6.2.6 Approximate identification of HPC location(s)
For equipment with moving elements/components, there is frequently a significant variation in the
concentration of particles generated between different zones of the equipment. The intention of the
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SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
cleanroom suitability methodology is to include those zones that contain HPC(s) within the suitability
assessment measurements.
The objective of this stage of the assessment is to determine the measuring locations of HPC(s)
that shall be included in the subsequent final suitability measurement. It is essential that moving
elements/components, utilities, interfaces, etc., are included in this assessment.
NOTE The number of moving elements/components can influence the number of approximate HPC locations.
Although safe sampling can impose sampling position limitations, the objective is to vary the distance
and/or position of the sampling probe in order to identify the HPC location(s).
The approximate identification shall be performed using a systematic scan of the equipment with a
light scattering discrete airborne particle counter (LSAPC). The entire system including product spaces
of the equipment should be scanned by the sampling probe. While the equipment is scanned using a
sampling probe of the LSAPC, a correlation between its position and the HPC is acquired. Depending on
the make/model of the LSAPC used, the feedback required to establish this correlation can use visual
and/or acoustic means. The sample acquisition time shall be chosen to ensure that the location of the
HPC(
...
SLOVENSKI STANDARD
SIST EN ISO 14644-14:2016
01-december-2016
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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
SIST EN ISO 14644-14:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14644-14:2016
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SIST EN ISO 14644-14:2016
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.
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SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
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.
3
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SIST EN ISO 14644-14:2016
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 14644-14:2016
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 2016 – All rights reserved iii
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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.
© ISO 2016 – All rights reserved v
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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 2016 – All rights reserved 3
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SIST EN ISO 14644-14:2016
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
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SIST EN ISO 14644-14:2016
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 2016 – All rights reserved 5
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SIST EN ISO 14644-14:2016
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 measurement results. This can be achieved using unidirectional airflow.
6.2.6 Approximate identification of HPC location(s)
For equipment with moving elements/components, there is frequently a significant variation in the
concentration of particles generated between different zones of the equipment. The intention of the
6 © ISO 2016 – All rights reserved
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SIST EN ISO 14644-14:2016
ISO 14644-14:2016(E)
cleanroom suitability methodology is to include those zones that contain HPC(s) within the suitability
assessment measurements.
The objective of this stage of the assessment is to determine the measuring locations of HPC(s)
that shall be included in the subsequent final suitability measurement. It is essential that moving
elements/components, utilities, interfaces, etc., are included in this assessment.
NOTE The number of moving elements/components can influence the number of approximate HPC locations.
Although safe sampling can impose sampling position limitations, the objective is to vary the distance
and/or position of the sampling probe in order to identify the HPC location(s).
The approximate identification shall be performed using a systematic scan of the equipment with a
light scattering discrete airborne particle counter (LSAPC). The entire system including product spaces
of the equipment should be scanned by the sampling probe. While the equipment is scanned using a
sampling probe of the LSAPC, a correlation between its position and the HPC is acquired. Depending on
the make/model of the LSAPC used, the feedback required to establish this correlation can use visual
and/or acoustic means. The sample acquisition time shall be chosen to ensure that the lo
...
SLOVENSKI STANDARD
oSIST prEN ISO 14644-14:2014
01-december-2014
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Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO/DIS 14644-14)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO/DIS
14644-14:2014)
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/DIS 14644-14:2014)
Ta slovenski standard je istoveten z: prEN ISO 14644-14
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-14:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 14644-14:2014
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oSIST prEN ISO 14644-14:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-14
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2014-10-02 2015-03-02
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: Evaluation de la compatibilité des équipments en termes d’émission particulaire pour une
utilisation en salle propre
ICS: 13.040.35
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-14:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
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oSIST prEN ISO 14644-14:2014
ISO/DIS 14644-14:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
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oSIST prEN ISO 14644-14:2014
Contents Page
Foreword .3
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 General outline of the assessment .7
5 Visual inspection .8
6 Assessment of suitability by airborne particle concentration measurements .8
7 Documentation . 15
8 Statement on cleanroom suitability . 17
Annex A (informative) Example for data processing for determining the cleanroom suitability
deriving from measurements . 18
Annex B (informative) Additional tests as options . 21
Bibliography . 24
© ISO 2014 – All rights reserved
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oSIST prEN ISO 14644-14:2014
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14644-14 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments and by Technical Committee CEN/TC 243, Cleanroom technology in collaboration.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
Part 1: Classification of air cleanliness by particle concentration
Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle
concentration
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 8: Classification of air cleanliness by chemical concentration (ACC)
Part 9: Classification of surface cleanliness by particle concentration
Part 10: Classification of surface cleanliness by chemical concentration
Part 12: Classification of air cleanliness by nanoscale particle concentration
Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical
classifications
Part 14: Assessment of suitability for use of equipment by airborne particle concentration
Part 15: Assessment of suitability for use of equipment and materials by airborne chemical and surface
chemical concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-
contamination control:
Part 1: General principles and methods
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oSIST prEN ISO 14644-14:2014
Part 2: Evaluation and interpretation of biocontamination data
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oSIST prEN ISO 14644-14:2014
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, healthcare).
This document links the cleanroom classification of air cleanliness by particle concentration (referred to by the
initialism ACP) to the suitability of equipment for use in cleanrooms and associated controlled environments.
Table 1 gives guidance to the user and explains the links between the area of interest (“Contamination of
interest”), the assessment standards (“Applicable assessment standard”) and the related ISO 14644 standard
(“Reference classification standard”).
Table 1 — Links between contamination of interest and assessment standard
Applicable Reference
Contamination Item to be
Category assessment classification Designation
of interest assessed
standard standard
ISO N
particle airborne equipment 14644-14 14644-1
a
particle airborne materials - 14644-1 ISO N
a
particle surface equipment 14644-9 ISO-SCP
-
a
particle surface materials - 14644-9 ISO-SCP
b
chemical airborne equipment 14644-8 ISO-ACC
14644-15
b
chemical airborne materials 14644-15 14644-8 ISO-ACC
a
chemical surface equipment - 14644-10 ISO-SCC
a
chemical surface materials - 14644-10 ISO-SCC
a
There might be future "Applicable assessment standards".
b
ISO 14644-15 is under preparation by ISO/TC 209/WG 11
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1 Scope
This part of ISO 14644 specifies a methodology to assess the suitability of equipment (e. g. machinery,
measuring equipment, process equipment, components, 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 ISO 14644-14:
- Assessment of suitability with respect to bio-contamination;
- 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 referenced documents are indispensable for the application of this document. 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:XXXX, Cleanroom and associated controlled environments - Part 1: Classification of air
cleanliness by particle concentration
ISO 14644-3, Cleanrooms and associated controlled environments - Part 3: Test methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
equipment
materials, components and controls, in a system, designed and integrated for a specific function
EXAMPLE testing and manufacturing equipment and machinery; equipment for transport and handling; storage
units; tools; furniture; doors; ceilings; IT hardware; handling robots
3.2
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 standard, the assessment is based on airborne particle concentration.
3.3
test environment
space in which the test is carried out, described by a set of parameters
3.4
cleanliness
condition not exceeding a specified level of contamination
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3.5
decontamination
removal of undesirable material down to a specified level
[ISO 14644-7:2004]
3.6
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.
[ISO 14644-1:XXXX]
3.7
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.
Note 5 to entry: A clean zone might also be subject to control of air cleanliness in terms of chemical, viable or nanoscale
concentrations, as also to control of surface cleanliness in terms of particle, nanoscale, chemical and viable
concentrations.
[ISO 14644-1:XXXX]
4 General outline of the assessment
Cleanroom suitability assessment has the following outline:
1. 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 (ACP), 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.
2. A short description how the equipment will be used in routine operation (with operating parameters)
shall be given to promote setting the appropriate testing condition and parameters.
3. Visual inspection (see clause 5)
4. The procedure described in clause 6 shall be used in order to establish a link to the ISO 14644-1
classification system.
NOTE For particle sizes larger than 5 µm the procedure for M descriptor according to ISO 14644-1 should be
used.
5. Execution of measurements (see 6.2 )
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6. The data gathered will be processed and the results linked to the ISO classification system (see 6.2.9
– 6.2.10)
7. The results obtained shall conclude the equipment’s clean room suitability; the statement shall follow
the defined designation (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 Annex 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 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 may include assessment for particles, surface films or
inappropriately located lubricants.
The objectives of this inspection are:
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 provides a measurement of surface cleanliness.
Depending on the location of the contamination, the results from visual inspection should be:
Recorded and available for comparison with the post- test visual inspection of surface cleanliness.
Be 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.
Materials used for equipment construction, their surface condition and treatment.
Viewing parameters (e. g. illumination, field of view, vision magnification, viewing distance).
For particle contamination in particular it may be useful to assess particle mobility. The use of probes, forced
clean dry air, vacuum device or tape lift could be used.
6 Assessment of suitability by airborne particle concentration measurements
6.1 General
The objective of this clause 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) suitability can be derived related to the intended application cleanroom classification.
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 are identified and included in the final suitability measurement. Since the size distribution of
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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 to the
air cleanliness by particle concentration (ACP) limits for ISO Class N as specified in ISO 14644-1.
For the equipment to be tested it has to be ensured that cleanroom compliant design principles have been
incorporated. These principles include, but are not limited to:
• 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 flow chart in Figure 1 gives an overview of the necessary assessment steps:
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6.2.2
Requirements and
considerations
6.2.3
Representative mode NO
of operation
6.2.4
Assessment of test
environment
6.2.5
Determination of the
test environment
6.2.6
Approximate
YES
identification of HPC
locations
Have significant
equipment operational
Parameters optimised or
parameter or set up YES
issues resolved?
errors been
identified ?
6.2.7
Precise determination
NO
of HPC locations
6.2.8
Suitability
measurements
6.2.9
Data
processing
6.2.10
8.0
Reference to
7.0
Statement on
ISO 14644-1
Documentation
cleanroom suitability
classification system
Figure 1 — Overview of the assessment procedure
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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.
The test environment shall be agreed upon before testing. The cleanliness class of the test environment shall
be at least one class better than the desired ISO Class (N) in which the equipment will be used.
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 has to reflect the intended use of the equipment. In case 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 Assessment of the test environment
The objective of these tests is to characterise 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 may be obtained from ISO 14644-1 and -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 (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 may include:
Airflow direction test and visualisation
Electrostatic and ion generator test
Particle deposition test
The results of the assessment shall be used for the determination of the test environment (see 6.2.5).
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6.2.5 Determination of the test environment
The test environment shall provide a background level at least one ISO Class (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 measurement results. This can be achieved using unidirectional airflow.
6.2.6 Approximate identification of HPC location(s)
For equipment with moving elements/components there is frequently a significant variation in the
concentration of particles generated between different zones of the equipment. The intention of the cleanroom
suitability methodology is to include those zones that contain HPC(s) within the suitability assessment
measurements.
The objective of this stage of the assessment is to determine the measuring locations of HPC(s) that shall be
included in the subsequent final suitability measurement. It is essential that moving elements/components,
utilities, interfaces, etc., are included in this assessment.
NOTE The number of moving elements/components may influence the number of approximate HPC locations.
Although safe sampling may impose sampling position limitations, the objective is to vary the distance and/or
position of the sampling probe in order to identify the HPC location(s).
The approximate identification shall be performed using a systematic scan of the equipment with a Discrete
Particle Counter (DPC). The entire system including product spaces of the equipment should be scanned by
the sampling probe. While the equipment is scanned using a sampling probe of the DPC, a correlation
between its position and the HPC is acquired. Depending on the make/model of the DPC used, the feedback
required to establish this correlation may use visual and/ or acoustic means. The sample acquisition time has
to be chosen to ensure that the location of the HPC(s) can be identified appropriately.
NOTE Previously identified contamination sources (output of any pre-tests) should be included in this part of the
assessment.
The conclusions of the measurements undertaken for the approximate identification of particle sources are
qualitative in nature.
6.2.7 Precise determination of HPC location(s)
Following the approximate identification, a precise determination of HPC location(s) is carried out using a DPC
2
assessing at least 28,3 litre of air per min with a probe having an openness limited to 20 cm . During this
measurement stage the geometrical position of the DPC sampling probe is adjusted to achieve the optimum
sampling of the HPC location. Probe position shall be set and recorded. This is repeated for each HPC
location identified under 6.2.6.
NOTE The number of measuring locations will be influenced by the number of moving elements/components.
6.2.8 Suitability measurement(s)
The HPC location(s) with the highest particle concentration shall be selected for the suitability measurement.
Select at least one HPC location for the suitability measurement based on measuring results obtained in 6.2.7.
In addition to the HPC location(s) identified under 6.2.7 it is expected that additional measurement locations
(e. g. associated with product handling, are included).
Perform particle concentration measurement(s) at selected location(s) using a DPC as described in 6.2.7.
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The following parameters, required for performing the suitability measurements, shall be specified and
recorded:
• Modes of operation of the equipment;
• Number of operating cycles of the equipment;
• Positioning of the equipment to be tested;
• HPC location(s) derived from approximate identification and precise determination;
• Additional measurement point(s) derived from a specific point of interest (e. g. product critical location);
• Positioning of the measuring DPC sampling probe(s);
• Particle size range(s) being assessed;
• The total sample volume according to ISO 14644-1;
• Number of consecutive independent readings at each individual measurement location. For statistical
reasons this number shall be ≥ 100.
NOTE The acquired data from the DPC may be captured, processed and then analysed using suitable software in
order to avoid transcription errors.
6.2.9 Data processing
The following data processing procedure shall be applied to the readings of particle concentrations obtained in
6.2.8. All specified particle size ranges shall be taken into consideration.
A statistical distribution of the particles in the air is assumed in order to obtain significant results from the
statistical analyses to be performed.
In case particle sizes are assessed which are not explicitly listed in the air cleanliness classification table of
ISO 14644-1, equation (1) can be used.
2,08
0,1
N
c = 10 × (1)
n
D
Where
c is the maximum permitted concentration (in particles per cubic metre of air) of airborne particles
...
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