SIST EN ISO 14644-3:2006

SLOVENSKI STANDARD
SIST EN ISO 14644-3:2006
01-september-2006
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO3UHVNXVQHPHWRGH,62

Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-
3:2005)
Reinräume und zugehörige Reinraumbereiche - Teil 3: Prüfverfahren (ISO 14644-
3:2005)
Salles propres et environnements maîtrisés apparentés - Partie 3: Méthodes d'essai
(ISO 14644-3:2005)
Ta slovenski standard je istoveten z: EN ISO 14644-3:2005
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-3:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-3:2006

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SIST EN ISO 14644-3:2006
EUROPEAN STANDARD
EN ISO 14644-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2005
ICS 13.040.35

English Version
Cleanrooms and associated controlled environments - Part 3:
Test methods (ISO 14644-3:2005)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 3:
Partie 3: Méthodes d'essai (ISO 14644-3:2005) Prüfverfahren (ISO 14644-3:2005)
This European Standard was approved by CEN on 12 September 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-3:2005: E
worldwide for CEN national Members.

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SIST EN ISO 14644-3:2006

EN ISO 14644-3:2005 (E)





Foreword


This document (EN ISO 14644-3:2005) 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 June 2006, and conflicting national
standards shall be withdrawn at the latest by June 2006.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 14644-3:2005 has been approved by CEN as EN ISO 14644-3:2005 without any
modifications.

2

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SIST EN ISO 14644-3:2006


INTERNATIONAL ISO
STANDARD 14644-3
First edition
2005-12-15


Cleanrooms and associated controlled
environments —
Part 3:
Test methods
Salles propres et environnements maîtrisés apparentés —
Partie 3: Méthodes d'essai





Reference number
ISO 14644-3:2005(E)
©
ISO 2005

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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
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ii © ISO 2005 – All rights reserved

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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
3.1 General. 2
3.2 Airborne particle measurement. 2
3.3 Air filters and systems . 4
3.4 Airflow and other physical states . 5
3.5 Electrostatic measurement. 5
3.6 Measuring apparatus and measuring conditions. 6
3.7 Occupancy states . 7
4 Test procedures . 8
4.1 Cleanroom tests. 8
4.2 Principle. 9
5 Test reports . 11
Annex A (informative) Choice of recommended tests of an installation and the sequence in which
to carry them out. 12
Annex B (informative) Test methods. 16
Annex C (informative) Test apparatus. 51
Bibliography . 64

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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(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.
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 14644-3 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environements.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
⎯ Part 1: Classification of air cleanliness
⎯ Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
⎯ 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 airborne molecular contamination
The following part is under preparation:
⎯ Part 6: Vocabulary
iv © ISO 2005 – All rights reserved

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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the
control of airborne contamination include those in such industries as aerospace, microelectronics,
pharmaceuticals, medical devices, healthcare and food.
This part of ISO 14644 sets out test methods that may be used for the purpose of characterizing a cleanroom
as described and specified in other parts of ISO 14644.
NOTE Not all cleanroom parameter test procedures are shown in this part of ISO 14644. The procedures and
apparatus to characterize other parameters, of concern in cleanrooms and clean zones used for specific products or
processes, are discussed elsewhere in other documents prepared by ISO/TC 209 [for example, procedures for control and
measurement of viable materials (ISO 14698), testing cleanroom functionality (ISO 14644-4), and testing of separative
devices (ISO 14644-7)]. In addition, other standards can be considered to be applicable.
Statements in this part of ISO 14644 reference the standards of ASTM, CEN, DIN, IEST, JACA, JIS and SEMI.

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SIST EN ISO 14644-3:2006

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SIST EN ISO 14644-3:2006
INTERNATIONAL STANDARD ISO 14644-3:2005(E)

Cleanrooms and associated controlled environments —
Part 3:
Test methods
WARNING — The use of this part of ISO 14644 may involve hazardous materials, operations and
equipment. This part of ISO 14644 does not purport to address all of the safety problems associated
with its use. It is the responsibility of the user of this part of ISO 14644 to establish appropriate safety
and health practices and to determine the applicability of regulatory limitations prior to use.
1 Scope
This part of ISO 14644 specifies test methods for designated classification of airborne particulate cleanliness
and for characterizing the performance of cleanrooms and clean zones. Performance tests are specified for
two types of cleanrooms and clean zones: those with unidirectional flow and those with non-unidirectional flow,
in three possible occupancy states: as-built, at-rest and operational. The test methods recommend test
apparatus and test procedures for determining performance parameters. Where the test method is affected by
the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several
different methods and apparatus are recommended to accommodate different end-use considerations.
Alternative methods not included in this part of ISO 14644 may be used if based on agreement between
customer and supplier. Alternative methods do not necessarily provide equivalent measurements.
This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms or
separative devices.
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 7726:1998, Ergonomics of the thermal environment — Instruments for measuring physical quantities
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing
and monitoring to prove continued compliance with ISO 14644-1
ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
cleanroom
room in which the concentration of airborne particles is controlled, and which is constructed and used in a
manner to minimize the introduction, generation and retention of particles inside the room, and in which other
relevant parameters, e.g. temperature, humidity and pressure, are controlled as necessary
[ISO 14644-1:1999, 2.1.1]
3.1.2
clean zone
dedicated space in which the concentration of airborne particles is controlled, and which is constructed and
used in a manner to minimize the introduction, generation and retention of particles inside the zone, and in
e.g.
which other relevant parameters, temperature, humidity and pressure, are controlled as necessary
NOTE This zone may be open or enclosed, and may or may not be located within a cleanroom.
[ISO 14644-1:1999, 2.1.2]
3.1.3
installation
cleanroom or one or more clean zones, together with all associated structures, air-treatment systems,
services, and utilities
[ISO 14644-1:1999, 2.1.3]
3.1.4
separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between the
inside and outside of a defined volume
NOTE Some industry-specific examples of separative devices are clean air hoods, containment enclosures, glove
boxes, isolators and mini-environments.
3.2 Airborne particle measurement
3.2.1
aerosol generator
e.g.
instrument capable of generating particulate matter having appropriate size range ( 0,05 µm to 2 µm) at a
constant concentration, which may be produced by thermal, hydraulic, pneumatic, acoustic or electrostatic
means
3.2.2
airborne particle
solid or liquid object suspended in air, viable or non-viable, sized (for the purpose of this part of ISO 14644)
between 1 nm and 100 µm
NOTE For classification purposes, refer to ISO 14644-1:1999, 2.2.1.
3.2.3
count median particle diameter
CMD
median particle diameter based on the number of particles
NOTE For the count median, one half of the particle number is contributed by the particles with a size smaller than
the count median size, and one half by particles larger than the count median size.
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.2.4
macroparticle
particle with an equivalent diameter greater than 5 µm
[ISO 14644-1:1999, 2.2.6]
3.2.5
M descriptor
measured or specified concentration of macroparticles per cubic metre of air, expressed in terms of the
equivalent diameter that is characteristic of the measurement method used
NOTE The M descriptor may be regarded as an upper limit for the averages at sampling locations (or as an upper
confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone).
M descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or
in conjunction with airborne particulate cleanliness classes.
[ISO 14644-1:1999, 2.3.2]
3.2.6
mass median particle diameter
MMD
median particle diameter based on the particle mass
NOTE For the mass median, one half of mass of all particles is contributed by particles with a size smaller than the
mass median size, and one half by particles larger than the mass median size.
3.2.7
particle concentration
number of individual particles per unit volume of air
[ISO 14644-1:1999, 2.2.3]
3.2.8
particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent to the
response produced by the particle being measured
NOTE For discrete-particle-counting, light-scattering instruments, the equivalent optical diameter is used.
[ISO 14644-1:1999, 2.2.2]
3.2.9
particle size distribution
cumulative distribution of particle concentration as a function of particle size
[ISO 14644-1:1999, 2.2.4]
3.2.10
test aerosol
gaseous suspension of solid and/or liquid particles with known and controlled size distribution and
concentration
3.2.11
U descriptor
measured or specified concentration in particles per cubic metre or air, including the ultrafine particles
NOTE The U descriptor may be regarded as an upper limit for the averages at sampling locations (or as an upper
confidence limit, depending upon the number of sampling locations used to characterize the cleanroom or clean zone).
U descriptors cannot be used to define airborne particulate cleanliness classes, but they may be quoted independently or
in conjunction with airborne particulate cleanliness classes.
[ISO 14644-1:1999, 2.3.1]
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.2.12
ultrafine particle
particle with an equivalent diameter less than 0,1 µm
[ISO 14644-1:1999, 2.2.5]
3.3 Air filters and systems
3.3.1
aerosol challenge
challenging of a filter or an installed filter system by test aerosol
3.3.2
designated leak
maximum allowable penetration, which is determined by agreement between customer and supplier, through
a leak, detectable during scanning of an installation with discrete-particle counters or aerosol photometers
3.3.3
dilution system
system wherein aerosol is mixed with particle-free dilution air in a known volumetric ratio to reduce
concentration
3.3.4
filter system
system composed of filter, frame and other support system or other housing
3.3.5
final filter
filters in a final position before the air enters the cleanroom
3.3.6
installed filter system
filter system mounted in the ceiling, wall, apparatus or duct
3.3.7
installed filter system leakage test
test performed to confirm that the filters are properly installed by verifying that there is absence of bypass
leakage in the installation, and that the filters and the grid system are free of defects and leaks
3.3.8
leak
〈of air filter system〉 penetration of contaminants that exceed an expected value of downstream concentration
through lack of integrity or defects
3.3.9
scanning
method for disclosing leaks in filters and parts of units, whereby the probe inlet of an aerosol photometer or
discrete-particle counter is moved in overlapping strokes across the defined test area
3.3.10
standard leak penetration
leak penetration detected by a discrete-particle counter or aerosol photometer with a standard sample flow-
rate when the sampling probe is stationary in front of the leak
NOTE Penetration is the ratio of the particle concentration downstream of the filter to the concentration upstream.
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.4 Airflow and other physical states
3.4.1
air exchange rate
rate of air exchange expressed as number of air changes per unit of time and calculated by dividing the
volume of air delivered in the unit of time by the volume of the space
3.4.2
average airflow rate
averaged volume of air per unit of time, to determine the air exchange rate in a cleanroom or clean zone
3
NOTE Airflow rate is expressed in cubic metres per hour (m /h).
3.4.3
measuring plane
cross-sectional area for testing or measuring a performance parameter such as the airflow velocity
3.4.4
non-unidirectional airflow
air distribution where the supply air entering the clean zone mixes with the internal air by means of induction
[ISO 14644-4:2001, 3.6]
3.4.5
supply airflow rate
air volume supplied into an installation from final filters or air ducts in unit of time
3.4.6
total airflow rate
air volume that passes through a section of an installation in unit of time
3.4.7
unidirectional airflow
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately
parallel streamlines
NOTE This type of airflow results in a directed transport of particles from the clean zone.
[ISO 14644-4:2001, 3.11]
3.4.8
uniformity of airflow
unidirectional airflow pattern in which the point-to-point readings of velocities are within a defined percentage
of the average airflow velocity
3.5 Electrostatic measurement
3.5.1
discharge time
time required to reduce the voltage to the level, positive or negative, to which an isolated conductive
monitoring plate was originally charged
3.5.2
offset voltage
voltage that will accumulate upon an initially uncharged isolated conductive plate when that plate is exposed
to an ionized air environment
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.5.3
static-dissipative property
capability for reducing electrostatic charge on work or product surface, as a result of conduction or other
mechanism to a specific value or nominal zero charge level
3.5.4
surface voltage level
positive or negative voltage level of electrostatic charging on work or product surface, as indicated by use of
suitable apparatus
3.6 Measuring apparatus and measuring conditions
3.6.1
aerosol photometer
light-scattering airborne particle mass concentration measuring apparatus, which uses a forward-scattered-
light optical chamber to make measurements
3.6.2
anisokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inlet is significantly different
from the mean velocity of the unidirectional airflow at that location
3.6.3
cascade impactor
sampling device, which collects particles from an aerosol using the principle of impaction upon a series of
collector surfaces
NOTE Each successive collector surface is exposed to an aerosol stream flowing at a higher velocity than was the
previous one, thus allowing collection of smaller particles than the previous one.
3.6.4
condensation nucleus counter
CNC
instrument that is capable of enlarging ultrafine particles by means of condensation for subsequent counting
using optical particle counting techniques
3.6.5
counting efficiency
ratio of the reported concentration of particles in a given size range to the actual concentration of such
particles
3.6.6
differential mobility analyzer
DMA
instrument for measuring the particle size distribution, based on the electrical mobility of particles
3.6.7
diffusion battery element
individual component from a multi-stage particle size cutoff device, operating on the principle of diffusion to
remove smaller particles from an aerosol stream
3.6.8
discrete-particle counter
DPC
instrument having a means of displaying and recording the count and size of discrete particles (with a size
discrimination) for specific air volume
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.6.9
false count
background noise count
zero count
count produced by a discrete-particle counter (DPC) due to internal or external unwanted electronic signal
when no particles exist
3.6.10
flowhood with flowmeter
device with apparatus to directly measure the airflow volume at each final filter or air diffuser in an installation,
set up to completely cover the filter or diffuser
3.6.11
iso-axial sampling
sampling condition in which the direction of the airflow into the sample probe inlet is the same as that of the
unidirectional airflow being sampled
3.6.12
isokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inlet is the same as the
mean velocity of the unidirectional airflow at that location
3.6.13
particle size cutoff device
device capable of removing particles smaller than those of interest that is attached to the inlet of a DPC or
CNC
3.6.14
threshold size
selected minimum particle size chosen for measuring a concentration of particles larger than or equal to that
size
3.6.15
time-of-flight particle size measurement
measurement of aerodynamic particle diameter determined by the time required for travelling the distance of
two fixed planes
NOTE This measurement utilizes the particle velocity shift caused when a particle is introduced into the flow field with
different velocity.
3.6.16
virtual impactor
instrument to separate the particle sizing by inertial force to collide on the hypothetical (virtual) surface
NOTE Large particles pass through the surface into a stagnant volume and small particles deflected with the bulk of
the original airflow.
3.6.17
witness plate
contamination-sensitive material of defined surface area used in lieu of direct evaluation of a specific surface
that is either inaccessible or too sensitive to be handled
3.7 Occupancy states
3.7.1
as-built
condition where the installation is complete with all services connected and functioning but with no production
equipment, materials, or personnel present
[ISO 14644-1:1999, 2.4.1]
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SIST EN ISO 14644-3:2006
ISO 14644-3:2005(E)
3.7.2
at-rest
condition where the installation is complete with equipment installed and operating in a manner agreed upon
by the customer and supplier, but with no personnel present
[ISO 14644-1:1999, 2.4.2]
3.7.3
operational
condition where the installation is functioning in the specified manner, with the specified number of personnel
present and working in the manner agreed upon
[ISO 14644-1:1999, 2.4.3]
4 Test procedures
4.1 Cleanroom tests
4.1.1 Required test
An airborne particle count test (see Table 1) shall be carried out in order to classify an installation in
accordance with ISO 14644-1, at the time intervals specified in ISO 14644-2.
Table 1 — Required test for installation
Reference in ISO 14644-3:2005
Required tests Referenced in
Principle Procedure Apparatus
Airborne particle count for classification
ISO 14644-1 and
and test measurement of cleanrooms and 4.2.1 B.1 C.1
ISO 14644-2
clean air devices
4.1.2 Optional tests
Table 2 lists other tests appropriate for testing of an installation. These tests can be applied in each of the
three designated occupancy states. These tests may not be all-inclusive, nor may all of the tests be required
for any given certification project. Tests and test methods should be selected in a manner agreed between the
customer and supplier. Selected tests can also be repeated on a regular basis as part of a routine facility
monitoring program (see ISO 14644-2). Guidelines for the selection of tests and a
...