A Reference number
ISO 14644-1:1999(E)
INTERNATIONAL
STANDARD
ISO
14644-1
First edition
1999-05-01
Cleanrooms and associated controlled
environments —
Part 1:
Classification of air cleanliness
Salles propres et environnements maîtrisés apparentés —
Partie 1: Classification de la propreté de l'air
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ISO 14644-1:1999(E) © ISO
ii
Contents
Page
Foreword ......................................................................................................... iii
Introduction ..................................................................................................... iv
1 Scope ........................................................................................................ 1
2 Definitions .................................................................................................. 1
3 Classification ............................................................................................. 3
4 Demonstration of compliance .................................................................... 4
Annexes
Annex A (informative) Graphical illustration of the classes of Table 1 ............ 5
Annex B (normative) Determination of particulate cleanliness classification
using a discrete-particle-counting, light-scattering instrument ...... 6
Annex C (normative) Statistical treatment of particle concentration data ..... 9
Annex D (informative) Worked examples of classification calculations ........ 10
Annex E (informative) Considerations for the counting and sizing of particles
outside the size range applicable for classification ..................... 13
Annex F (informative) Sequential sampling procedure ................................ 15
Bibliography ................................................................................................... 18
Figures
Figure A.1 Graphical representation of ISO-class concentration limits
for selected ISO classes ............................................................... 5
Figure F.1 Boundaries for pass or fail by the sequential sampling
procedure .................................................................................. 15
Tables
Table 1 Selected airborne particulate cleanliness classes for
cleanrooms and clean zones ........................................................ 3
Table C.1 Student’s t distribution for the 95% upper confidence limit ........... 9
Table F.1 Upper and lower limits for time at which C observed counts
should arrive ............................................................................... 16
© ISO 1999
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or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
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Internet iso@iso.ch
Printed in Switzerland
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© ISO
ISO 14644-1:1999(E)
iii
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
nongovernmental, 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.
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.
International Standard ISO 14644-1 was prepared by Technical Committee ISO/TC 209,
Cleanrooms and associated controlled environments.
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: Metrology and test methods
— Part 4: Design, construction and start-up
— Part 5: Operations
— Part 6: Terms and definitions
— Part 7: Enhanced clean devices
Users should note that the titles listed for parts 2 to 7 are working titles at the time of the
release of part 1. In the event that one or more of these parts are deleted from the work
programme, the remaining parts may be renumbered.
Annexes B and C form an integral part of this part of ISO 14644. Annexes A, D, E, and F
are for information only.
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Introduction
Cleanrooms and associated controlled environments provide for the control of airborne
particulate 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, food, and healthcare.
This part of ISO 14644 assigns ISO classification levels to be used for the specification of
air cleanliness in cleanrooms and associated controlled environments. It also prescribes the
standard method of testing as well as the procedure for determining the concentration of
airborne particles.
For classification purposes, this part of ISO 14644 is limited to a designated range of
considered particle sizes for determination of particle concentration limits. This part of ISO
14644 also provides standard protocols for the determination and designation of cleanli-
ness levels that are based on airborne concentrations of particles smaller or larger than the
size range designated for classification.
This part of ISO 14644 is one of a series of standards concerned with cleanrooms and
contamination control. Many factors besides airborne particulate cleanliness must be
considered in the design, specification, operation, and control of cleanrooms and other
controlled environments. These are covered in some detail in other parts of the International
Standards prepared by ISO/TC 209.
In some circumstances, relevant regulatory agencies may impose supplementary policies
or restrictions. In such situations, appropriate adaptations of the standard testing proce-
dures may be required.
ISO 14644-1:1999(E) © ISO
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1
INTERNATIONAL STANDARD © ISO ISO 14644-1:1999(E)
1 Scope
This part of ISO 14644 covers the classification of air cleanli-
ness in cleanrooms and associated controlled environments
exclusively in terms of concentration of airborne particles.
Only particle populations having cumulative distributions based
on threshold (lower limit) sizes ranging from 0,1 µm to 5 µm are
considered for classification purposes.
This part of ISO 14644 does not provide for classification of
particle populations that are outside of the specified particle
size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles
(particles smaller than 0,1 µm) and macroparticles (particles
larger than 5 µm) may be used to quantify these populations in
terms of U descriptors and M descriptors, respectively.
This part of ISO 14644 cannot be used to characterize the
physical, chemical, radiological, or viable nature of airborne
particles.
NOTE The actual distribution of particle concentrations within incre-
mental size ranges normally is not predictable and typically is variable
over time.
2 Definitions
For the purposes of this part of ISO 14644, the following
definitions apply.
2.1 General
2.1.1
cleanroom
room in which the concentration of airborne particles is con-
trolled, and which is constructed and used in a manner to
minimize the introduction, generation, and retention of parti-
cles inside the room, and in which other relevant parameters,
e.g. temperature, humidity, and pressure, are controlled as
necessary
2.1.2
clean zone
dedicated space in which the concentration of airborne parti-
cles 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 which other relevant
parameters, e.g. 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.
2.1.3
installation
cleanroom or one or more clean zones, together with all
associated structures, air-treatment systems, services, and
utilities
2.1.4
classification
level (or the process of specifying or determining the level) of
airborne particulate cleanliness applicable to a cleanroom or
clean zone, expressed in terms of an ISO Class N, which
represents maximum allowable concentrations (in particles
per cubic metre of air) for considered sizes of particles
NOTE 1 The concentrations are determined by using equation (1)
in 3.2.
NOTE 2 Classification in accordance with this International Stan-
dard is limited to the range extending from ISO Class 1 through ISO
Class 9.
NOTE 3 The considered particle sizes (lower threshold values)
applicable for classification in accordance with this International
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness
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ISO 14644-1:1999(E) © ISO
2
Standard are limited to the range from 0,1 µm through 5 µm. Air
cleanliness may be described and specified (but not classified) in
terms of U descriptors or M descriptors (see 2.3.1 or 2.3.2) for
considered threshold particle sizes that are outside of the range
covered by classification.
NOTE 4 Intermediate ISO classification numbers may be speci-
fied, with 0,1 the smallest permitted increment; i.e., the range of
intermediate ISO classes extends from ISO Class 1,1 through ISO
Class 8,9.
NOTE 5 Classification may be specified or accomplished in any of
three occupancy states (see 2.4).
2.2 Airborne particles
2.2.1
particle
solid or liquid object which, for purposes of classification of air
cleanliness, falls within a cumulative distribution that is based
upon a threshold (lower limit) size in the range from 0,1 µm to
5 µm
2.2.2
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.
2.2.3
particle concentration
number of individual particles per unit volume of air
2.2.4
particle size distribution
cumulative distribution of particle concentration as a function of
particle size
2.2.5
ultrafine particle
particle with an equivalent diameter less than 0,1 µm
2.2.6
macroparticle
particle with an equivalent diameter greater than 5 µm
2.2.7
fibre
particle having an aspect (length-to-width) ratio of 10 or more
2.3 Descriptors
2.3.1
U descriptor
measured or specified concentration, of particles per cubic
metre of 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 character-
ize 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.
2.3.2
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 character-
ize 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.
2.4 Occupancy states
2.4.1
as-built
condition where the installation is complete with all services
connected and functioning but with no production equipment,
materials, or personnel present
2.4.2
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
2.4.3
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
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© ISO ISO 14644-1:1999(E)
3
2.5 Roles
2.5.1
customer
organization, or the agent thereof, responsible for specifying
the requirements of a cleanroom or clean zone
2.5.2
supplier
organization engaged to satisfy the specified requirements of
a cleanroom or clean zone
3 Classification
3.1 Occupancy state(s)
The particulate cleanliness of air in a cleanroom or clean zone
shall be defined in one or more of three occupancy states, viz.
“as-built”, “at-rest”, or “operational” (see 2.4).
NOTE It should be recognized that the “as-built” state is applicable
to newly completed or newly modified cleanrooms or clean zones.
Once testing in the “as-built” state is completed, further testing for
compliance will be performed in the “at-rest” or the “operational” state,
or both.
3.2 Classification number
Airborne particulate cleanliness shall be designated by a
classification number, N. The maximum permitted concentra-
tion of particles, Cn, for each considered particle size, D, is
determined from the equation:
C Dn
N
= ×
10
0 1 2 08, , (1)
where
Cn is the maximum permitted concentration (in parti-
cles per cubic metre of air) of airborne particles that
are equal to or larger than the considered particle
size. Cn is rounded to the nearest whole number,
using no more than three significant figures.
N is the ISO classification number, which shall not
exceed a value of 9. Intermediate ISO classification
numbers may be specified, with 0,1 the smallest
permitted increment of N.
D is the considered particle size, in micrometres.
0,1 is a constant, with a dimension of micrometres.
Table 1 presents selected airborne particulate cleanliness
classes and the corresponding particle concentrations for
particles equal to and larger than the considered sizes shown.
Figure A.1 (see annex A) provides a representation of the
OSI
noitacifissalc
(rebmun N)
m/selcitrap(stimilnoitartnecnocmumixaM 3 regraldnaotlauqeselcitraprof)riafo
nidetaluclacerastimilnoitartnecnoc(wolebnwohssezisderedisnocehtnaht
)2.3ni)1(noitauqehtiwecnadrocca
1,0 µm 2,0 µm 3,0 µm 5,0 µm 1 µm 5 µm
1ssalCOSI 01 2
2ssalCOSI 001 42 01 4
3ssalCOSI 0001 732 201 53 8
4ssalCOSI 00001 0732 0201 253 38
5ssalCOSI 000001 00732 00201 0253 238 92
6ssalCOSI 0000001 000732 000201 00253 0238 392
7ssalCOSI 000253 00238 0392
8ssalCOSI 0000253 000238 00392
9ssalCOSI 00000253 0000238 000392
eromonhtiwatadnoitartnecnoctahteriuqerssecorptnemerusaemehtotdetalerseitniatrecnUETON
levelnoitacifissalcehtgninimretednidesuebserugiftnacifingiseerhtnaht
Table 1 — Selected airborne particulate cleanliness classes for cleanrooms and clean zones
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ISO 14644-1:1999(E) © ISO
4
selected classes in graphical form. In case of dispute, the
concentration Cn as derived from equation (1) shall serve as
the standard value.
3.3 Designation
The designation of airborne particulate cleanliness for clean-
rooms and clean zones shall include:
a) the classification number, expressed as “ISO Class N ”;
b) the occupancy state to which the classification applies;
c) the considered particle size(s), and the related concen-
tration(s), as determined by the classification equation (1)
where each considered threshold particle size is in the range
from 0,1 µm through 5 µm.
Example designation:
ISO Class 4; operational state; considered sizes:
0,2 µm (2 370 particles/m3), 1 µm (83 particles/m3)
The considered particle size(s) for which the concentra-
tion(s) will be measured shall be agreed upon by the custom-
er and the supplier.
If measurements are to be made at more than one considered
particle size, each larger particle diameter (e.g., D2) shall be at
least 1,5 times the next smaller particle diameter (e.g., D1).
e.g.: D2 ≥ 1,5 x D1
4 Demonstration of compliance
4.1 Principle
Compliance with air cleanliness (ISO class) requirements
specified by the customer is verified by performing specified
testing procedures and by providing specified documentation
of the results and conditions of testing, as agreed upon by the
customer and the supplier.
4.2 Testing
The reference test method for demonstrating compliance is
given in annex B. An alternative method having comparable
accuracy may be specified, although if no method is specified
or agreed upon, the reference method shall be used.
Tests performed to demonstrate compliance shall be con-
ducted using calibrated instruments.
4.3 Airborne particle concentration
limits
Upon completion of testing in accordance with 4.2, average
particle concentrations and the 95% upper confidence limit
(when applicable) shall be calculated using equations shown
in annex C.
Average particle concentration(s), calculated in accordance
with equation (C.1), shall not exceed the concentration
limit(s) determined by use of equation (1) in 3.2, as specified
[3.3 c)] for the considered size(s).
In addition, for situations in which the number of sampling
locations involved is at least two but not more than nine, the
calculation of 95% upper confidence limits in accordance with
C.3 shall not exceed the concentration limits established
above.
NOTE Worked examples of classification calculations are provided
in annex D.
Particle concentrations used for determination of conformance
to classification limits shall be measured by the same method
for all considered particle sizes.
4.4 Test report
The results from testing each cleanroom or clean zone shall
be recorded and submitted as a comprehensive report, along
with a statement of compliance or n
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