EN ISO 14644-1:1999
(Main)Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)
This Part of this European Standard specifies the classification of particulate cleanliness for cleanrooms and clean air controlled spaces in three possible occupancy states according to the number concentration of airborne particulate matter present.
Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit (ISO 14644-1:1999)
Dieser Teil der Internationalen Norm ISO 14644 enthält die Klassifizierung der Luftreinheit in Reinräumen und zugehörigen Reinraumbereichen. Die Ausführungen und Festlegungen der Klassifizierung nach dieser Norm beziehen sich ausschließlich auf die Konzentration luftgetragener Partikel. Desweiteren werden für Klassifizierungßwecke nur Partikelgruppen in Betracht gezogen, deren Summenhäufigkeitsverteilung zwischen den kritischen Partikelgrößen ( untere Grenze) 0,1 um un 5 um basiert.
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la propreté de l'air (ISO 14644-1:1999)
La présente partie de l'ISO 14644 comprend la classification de la propreté de l'air des salles propres et environnements maîtrisés apparentés exclusivement en termes de concentration des particules en suspension dans l'air. Pour l'application de cette classification, on ne considère que les populations de particules présentant une distribution cumulée dont le seuil inférieur de sensibilité se situe dans l'étendue granulométrique de 0,1 µm à 5 µm. La présente partie de l'ISO 14644 ne donne pas la classification des populations de particules sortant de l'étendue granulométrique de référence de 0,1 µm à 5 µm. Les concentrations de particules ultrafines (plus petites que 0,1 µm) et de macroparticules (plus grandes que 5 µm) peuvent être utilisées pour quantifier ces populations en terme de descripteurs U et M. La présente partie de l'ISO 14644 n'est pas applicable pour caractériser la nature physique, chimique, radiologique ou viable des particules en suspension dans l'air.
NOTE La distribution granulométrique réelle de particules par taille à l'intérieur de l'étendue de référence n'est pas habituellement prévisible et est typiquement variable avec le temps.
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2000
Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness (ISO 14644-1:1999)
Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness (ISO 14644-1:1999)
Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit
(ISO 14644-1:1999)
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la
propreté de l'air (ISO 14644-1:1999)
Ta slovenski standard je istoveten z: EN ISO 14644-1:1999
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL ISO
STANDARD 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
A
Reference number
ISO 14644-1:1999(E)
ISO 14644-1:1999(E) © ISO
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
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 14644-1:1999(E)
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.
iv
INTERNATIONAL STANDARD © ISO ISO 14644-1:1999(E)
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness
1 Scope cles inside the room, and in which other relevant parameters,
e.g. temperature, humidity, and pressure, are controlled as
This part of ISO 14644 covers the classification of air cleanli-
necessary
ness in cleanrooms and associated controlled environments
exclusively in terms of concentration of airborne particles. 2.1.2
Only particle populations having cumulative distributions based
clean zone
on threshold (lower limit) sizes ranging from 0,1 μm to 5 μm are
dedicated space in which the concentration of airborne parti-
considered for classification purposes.
cles is controlled, and which is constructed and used in a
manner to minimize the introduction, generation, and retention
This part of ISO 14644 does not provide for classification of
of particles inside the zone, and in which other relevant
particle populations that are outside of the specified particle
parameters, e.g. temperature, humidity, and pressure, are
size range, 0,1 μm to 5 μm. Concentrations of ultrafine particles
controlled as necessary
(particles smaller than 0,1 μm) and macroparticles (particles
larger than 5 μm) may be used to quantify these populations in
NOTE This zone may be open or enclosed and may or may not be
terms of U descriptors and M descriptors, respectively.
located within a cleanroom.
This part of ISO 14644 cannot be used to characterize the
2.1.3
physical, chemical, radiological, or viable nature of airborne
installation
particles.
cleanroom or one or more clean zones, together with all
NOTE The actual distribution of particle concentrations within incre-
associated structures, air-treatment systems, services, and
mental size ranges normally is not predictable and typically is variable
utilities
over time.
2.1.4
classification
level (or the process of specifying or determining the level) of
2 Definitions
airborne particulate cleanliness applicable to a cleanroom or
For the purposes of this part of ISO 14644, the following
clean zone, expressed in terms of an ISO Class N, which
definitions apply. 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)
2.1 General
in 3.2.
2.1.1
NOTE 2 Classification in accordance with this International Stan-
cleanroom
dard is limited to the range extending from ISO Class 1 through ISO
room in which the concentration of airborne particles is con-
Class 9.
trolled, and which is constructed and used in a manner to
NOTE 3 The considered particle sizes (lower threshold values)
minimize the introduction, generation, and retention of parti-
applicable for classification in accordance with this International
ISO 14644-1:1999(E) © ISO
Standard are limited to the range from 0,1 μm through 5 μm. Air 2.3 Descriptors
cleanliness may be described and specified (but not classified) in
2.3.1
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
U descriptor
covered by classification.
measured or specified concentration, of particles per cubic
metre of air, including the ultrafine particles
NOTE 4 Intermediate ISO classification numbers may be speci-
fied, with 0,1 the smallest permitted increment; i.e., the range of
NOTE The U descriptor may be regarded as an upper limit for the
intermediate ISO classes extends from ISO Class 1,1 through ISO
averages at sampling locations (or as an upper confidence limit,
Class 8,9.
depending upon the number of sampling locations used to character-
ize the cleanroom or clean zone). U descriptors cannot be used to
NOTE 5 Classification may be specified or accomplished in any of
define airborne particulate cleanliness classes, but they may be
three occupancy states (see 2.4).
quoted independently or in conjunction with airborne particulate
cleanliness classes.
2.2 Airborne particles
2.3.2
2.2.1
M descriptor
particle
measured or specified concentration of macroparticles per
solid or liquid object which, for purposes of classification of air
cubic metre of air, expressed in terms of the equivalent
cleanliness, falls within a cumulative distribution that is based
diameter that is characteristic of the measurement method
upon a threshold (lower limit) size in the range from 0,1 μm to
used
5 μm
NOTE The M descriptor may be regarded as an upper limit for the
2.2.2 averages at sampling locations (or as an upper confidence limit,
depending upon the number of sampling locations used to character-
particle size
ize the cleanroom or clean zone). M descriptors cannot be used to
diameter of a sphere that produces a response, by a given
define airborne particulate cleanliness classes, but they may be
particle-sizing instrument, that is equivalent to the response
quoted independently or in conjunction with airborne particulate
produced by the particle being measured
cleanliness classes.
NOTE For discrete-particle-counting, light-scattering instruments,
the equivalent optical diameter is used.
2.4 Occupancy states
2.2.3
2.4.1
particle concentration
as-built
number of individual particles per unit volume of air
condition where the installation is complete with all services
connected and functioning but with no production equipment,
2.2.4
materials, or personnel present
particle size distribution
cumulative distribution of particle concentration as a function of
2.4.2
particle size
at-rest
condition where the installation is complete with equipment
2.2.5
installed and operating in a manner agreed upon by the
ultrafine particle
customer and supplier, but with no personnel present
particle with an equivalent diameter less than 0,1 μm
2.4.3
2.2.6
operational
macroparticle
condition where the installation is functioning in the specified
particle with an equivalent diameter greater than 5 μm
manner, with the specified number of personnel present and
working in the manner agreed upon
2.2.7
fibre
particle having an aspect (length-to-width) ratio of 10 or more
© ISO ISO 14644-1:1999(E)
Table 1 — Selected airborne particulate cleanliness classes for cleanrooms and clean zones
Maximum concentration limits (particles/m of air) for particles equal to and larger
ISO
than the considered sizes shown below (concentration limits are calculated in
classification
accordance with equation (1) in 3.2)
number (N)
0,1 μm20, μm30, μm50, μm1 μm5 μm
I0SO Class 1 12
I0SO Class 2 140 2014
I0SO Class 3 1700 223 150 38
I0SO Class 4100 00 2037 1202 335 8
I0SO Class 51000 00203 70100 20 3252 893 2
I0SO Class 610000 002037 001002 00305 20 8332 29
I0SO Class 7 3052 00803 20 2 93
I0SO Class 8 30520 008032 00 29 30
I0SO Class 9 305 200 0080320 00 293 00
NOTE Uncertainties related to the measurement process require that concentration data with no more
than three significant figures be used in determining the classification level
2.5 Roles 3.2 Classification number
Airborne particulate cleanliness shall be designated by a
2.5.1
classification number, N. The maximum permitted concentra-
customer
tion of particles, C , for each considered particle size, D, is
n
organization, or the agent thereof, responsible for specifying
determined from the equation:
the requirements of a cleanroom or clean zone
20, 8
01,
2.5.2 N
C=×10
(1)
n
D
supplier
organization engaged to satisfy the specified requirements of
where
a cleanroom or clean zone
C is the maximum permitted concentration (in parti-
n
cles per cubic metre of air) of airborne particles that
are equal to or larger than the considered particle
size. C is rounded to the nearest whole number,
n
3 Classification
using no more than three significant figures.
N is the ISO classification number, which shall not
3.1 Occupancy state(s)
exceed a value of 9. Intermediate ISO classification
numbers may be specified, with 0,1 the smallest
The particulate cleanliness of air in a cleanroom or clean zone
N.
permitted increment of
shall be defined in one or more of three occupancy states, viz.
“as-built”, “at-rest”, or “operational” (see 2.4).
D is the considered particle size, in micrometres.
NOTE It should be recognized that the “as-built” state is applicable
0,1 is a constant, with a dimension of micrometres.
to newly completed or newly modified cleanrooms or clean zones.
Table 1 presents selected airborne particulate cleanliness
Once testing in the “as-built” state is completed, further testing for
classes and the corresponding parti
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