SIST EN ISO 14644-1:2016
(Main)Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
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 anhand der Partikelkonzentration (ISO 14644-1:2015)
Dieser Teil der ISO 14644 enthält die Klassifizierung der Luftreinheit in Reinräumen und zugehörigen
Reinraumbereichen und bezieht sich ausschließlich auf die Konzentration luftgetragener Partikel. Des
Weiteren werden für Klassifizierungszwecke nur Partikelgruppen in Betracht gezogen, deren Summenhäufigkeitsverteilung
zwischen den kritischen Partikelgrößen (untere Grenze) 0,1 μm und 5 μm beruht.
Die Verwendung von Geräten zu Bestimmung von Anzahl und Größe einzelner Luftpartikel ist die Grundlage
für die Bestimmung der Konzentration luftgetragener Partikel gleich und größer dem festgelegten Größenbereich
an gekennzeichneten Probenahmeorten.
Dieser Teil der ISO 14644 trifft nicht auf die Klassifizierung von Partikelgruppen zu, die außerhalb des
festgelegten Größenbereichs 0,1 μm bis 5 μm liegen. Konzentrationen von ultrafeinen Partikel (Partikel
< 0,1 μm) und von Makropartikel (Partikel > 5 μm) können zur Quantifizierung dieser Partikelgruppen durch
die Verwendung von U-Deskriptoren bzw. M-Deskriptoren (siehe 3.3.1 and 3.3.2) bestimmt werden.
Dieser Teil der ISO 14664 eignet sich nicht zur Klassifizierung der physischen, chemischen, radiologischen
oder lebensfähigen Beschaffenheit von luftgetragenen Partikeln.
ANMERKUNG Die eigentliche Verteilung von Partikelkonzentrationen innerhalb zunehmender Größenbereiche ist
üblicherweise nicht vorhersehbar und variiert üblicherweise im Laufe der Zeit.
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la propreté particulaire de l'air (ISO 14644-1:2015)
La présente partie de cette norme européenne définit la classification de la propreté particulaire des salles propres et des espaces à empoussièrement contrôlé, pour trois états d'occupation possibles, selon la concentration des particules en suspension dans l'air.
Čiste sobe in podobna nadzorovana okolja - 1. del: Klasifikacija čistosti zraka na osnovi koncentracije delcev (ISO 14644-1:2015)
Ta del evropskega standarda določa klasifikacijo čistosti na osnovi koncentracije delcev v čistih sobah in prostorih z nadzorom čistega zraka v treh možnih stanjih glede na količino delcev, prisotnih v zraku.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14644-1:2016
01-marec-2016
1DGRPHãþD
SIST EN ISO 14644-1:2000
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO .ODVLILNDFLMDþLVWRVWL]UDNDQD
RVQRYLNRQFHQWUDFLMHGHOFHY ,62
Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness by particle concentration (ISO 14644-1:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit
anhand der Partikelkonzentration (ISO 14644-1:2015)
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la
propreté particulaire de l'air (ISO 14644-1:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-1:2015
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-1:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14644-1:2016
---------------------- Page: 2 ----------------------
SIST EN ISO 14644-1:2016
EN ISO 14644-1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-1:1999
English Version
Cleanrooms and associated controlled environments - Part
1: Classification of air cleanliness by particle concentration
(ISO 14644-1:2015)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 1:
- Partie 1: Classification de la propreté particulaire de Klassifizierung der Luftreinheit anhand der
l'air (ISO 14644-1:2015) Partikelkonzentration (ISO 14644-1:2015)
This European Standard was approved by CEN on 27 November 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-1:2015 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 14644-1:2016
EN ISO 14644-1:2015 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14644-1:2016
EN ISO 14644-1:2015 (E)
European foreword
This document (EN ISO 14644-1:2015) 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 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
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.
This document supersedes EN ISO 14644-1:1999.
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 14644-1:2015 has been approved by CEN as EN ISO 14644-1:2015 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 14644-1:2016
---------------------- Page: 6 ----------------------
SIST EN ISO 14644-1:2016
INTERNATIONAL ISO
STANDARD 14644-1
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 1:
Classification of air cleanliness by
particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 1: Classification de la propreté particulaire de l’air
Reference number
ISO 14644-1:2015(E)
©
ISO 2015
---------------------- Page: 7 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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 2015 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Airborne particles . 2
3.3 Occupancy states . 3
3.4 Testing instrumentation (see Annex F) . 3
3.5 Instrument specifications . 4
4 Classification . 4
4.1 Occupancy state(s) . 4
4.2 Particle size(s) . 4
4.3 ISO Class number . 4
4.4 Designation . 5
4.5 Intermediate decimal cleanliness classes and particle size thresholds . 5
5 Demonstration of compliance . 6
5.1 Principle . 6
5.2 Testing . 6
5.3 Airborne particle concentration evaluation . 6
5.4 Test report . 6
Annex A (normative) Reference method for classification of air cleanliness by
particle concentration . 8
Annex B (informative) Examples of classification calculations .13
Annex C (informative) Counting and sizing of airborne macroparticles .22
Annex D (informative) Sequential sampling procedure .27
Annex E (informative) Specification of intermediate decimal cleanliness classes and
particle size thresholds .34
Annex F (informative) Test instruments .36
Bibliography .37
© ISO 2015 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(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 WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces the first edition (ISO 14644-1:1999), which has been
technically revised throughout.
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
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments —
Biocontamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of biocontamination data
iv © ISO 2015 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination of air
and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities.
Contamination control can be beneficial for protection of product or process integrity in applications in
industries such as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food.
This part of ISO 14644 specifies classes of air cleanliness in terms of the number of particles expressed
as a concentration in air volume. It also specifies the standard method of testing to determine
cleanliness class, including selection of sampling locations.
This edition is the result of a response to an ISO Systematic Review and includes changes in response to
user and expert feedback validated by international enquiry. The title has been revised to “Classification
of air cleanliness by particle concentration” to be consistent with other parts of ISO 14644. The nine
ISO cleanliness classes are retained with minor revisions. Table 1 defines the particle concentration at
various particle sizes for the nine integer classes. Table E.1 defines the maximum particle concentration
at various particle sizes for intermediate classes. The use of these tables ensures better definition
of the appropriate particle-size ranges for the different classes. This part of ISO 14644 retains the
macroparticle descriptor concept; however, consideration of nano-scale particles (formerly defined as
ultrafine particles) will be addressed in a separate standard.
The most significant change is the adoption of a more consistent statistical approach to the selection and
the number of sampling locations; and the evaluation of the data collected. The statistical model is based
on adaptation of the hypergeometric sampling model technique, where samples are drawn randomly
without replacement from a finite population. The new approach allows each location to be treated
independently with at least a 95 % level of confidence that at least 90 % of the cleanroom or clean zone
areas will comply with the maximum particle concentration limit for the target class of air cleanliness.
No assumptions are made regarding the distribution of the actual particle counts over the area of the
cleanroom or clean zone; while in ISO 14644-1:1999 an underlying assumption was that the particle
counts follow the same normal distribution across the room, this assumption has now been discarded
to allow the sampling to be used in rooms where the particle counts vary in a more complex manner. In
the process of revision it has been recognized that the 95 % UCL was neither appropriate nor was applied
consistently in ISO 14644-1:1999. The minimum number of sampling locations required has been changed,
compared with ISO 14644-1:1999. A reference table, Table A.1, is provided to define the minimum number
of sampling locations required based on a practical adaptation of the sampling model technique. An
assumption is made that the area immediately surrounding each sampling location has a homogeneous
particle concentration. The cleanroom or clean zone area is divided up into a grid of sections of near equal
area, whose number is equal to the number of sampling locations derived from Table A.1. A sampling
location is placed within each grid section, so as to be representative of that grid section.
It is assumed for practical purposes that the locations are chosen representatively; a “representative”
location (see A.4.2) means that features such as cleanroom or clean zone layout, equipment disposition
and airflow systems should be considered when selecting sampling locations. Additional sampling
locations may be added to the minimum number of sampling locations.
Finally, the annexes have been reordered to improve the logic of this part of ISO 14644 and portions
of the content of certain annexes concerning testing and test instruments have been included from
ISO 14644-3:2005.
The revised version of this part of ISO 14644 addresses the ≥ 5 µm particle limits for ISO Class
5 in the sterile products annexes of the EU, PIC/S and WHO GMPs by way of an adaptation of the
macroparticle concept.
The revised version of this part of ISO 14644 now includes all matters related to classification of air
cleanliness by particle concentration. The revised version of ISO 14644-2:2015 now deals exclusively
with the monitoring of air cleanliness by particle concentration.
Cleanrooms may also be characterized by attributes in addition to the classification of air cleanliness by
particle concentration. Other attributes, such as air cleanliness in terms of chemical concentration, may
© ISO 2015 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
be monitored and the attribute’s grade or level may be designated along with the classification of the ISO
Class of cleanliness. These additional attributes do not suffice alone to classify a cleanroom or clean zone.
vi © ISO 2015 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 14644-1:2016
INTERNATIONAL STANDARD ISO 14644-1:2015(E)
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness by particle concentration
1 Scope
This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne
particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle
sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination
of the concentration of airborne particles, equal to and greater than the specified sizes, at designated
sampling locations.
This part of ISO 14644 does not provide for classification of particle populations that are outside the
specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles
(particles smaller than 0,1 µm) will be addressed in a separate standard to specify air cleanliness
by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of
macroparticles (particles larger than 5 µm).
This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, viable or
other nature of airborne particles.
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 14644-2:2015, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide
evidence of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-7, Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air
hoods, gloveboxes, isolators and mini-environments)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
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.
© ISO 2015 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
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.
3.1.2
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.
3.1.3
installation
cleanroom or one or more clean zones, together with all associated structures, air-treatment systems,
services and utilities
3.1.4
classification
method of assessing level of cleanliness against a specification for a cleanroom or clean zone
Note 1 to entry: Levels should be expressed in terms of an ISO Class, which represents maximum allowable
concentrations of particles in a unit volume of air.
3.2 Airborne particles
3.2.1
particle
minute piece of matter with defined physical boundaries
3.2.2
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 1 to entry: For discrete-particle light-scattering instruments, the equivalent optical diameter is used.
3.2.3
particle concentration
number of individual particles per unit volume of air
3.2.4
particle size distribution
cumulative distribution of particle concentration as a function of particle size
3.2.5
macroparticle
particle with an equivalent diameter greater than 5 µm
2 © ISO 2015 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
3.2.6
M descriptor
designation for 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 1 to entry: The M descriptor can be regarded as an upper limit for the averages at sampling locations.
M descriptors cannot be used to define ISO Classes, but the M descriptor may be quoted independently or in
conjunction with ISO Classes.
3.2.7
unidirectional airflow
controlled airflow through the entire cross-section of a cleanroom or a clean zone with a steady velocity
and airstreams that are considered to be parallel
3.2.8
non-undirectional airflow
air distribution where the supply air entering the cleanroom or clean zone mixes with the internal air
by means of induction
3.3 Occupancy states
3.3.1
as-built
condition where the cleanroom or clean zone is complete with all services connected and functioning
but with no equipment, furniture, materials or personnel present
3.3.2
at-rest
condition where the cleanroom or clean zone is complete with equipment installed and operating in a
manner agreed upon, but with no personnel present
3.3.3
operational
agreed condition where the cleanroom or clean zone is functioning in the specified manner, with
equipment operating and with the specified number of personnel present
3.4 Testing instrumentation (see Annex F)
3.4.1
resolution
smallest change in a quantity being measured that causes a perceptible change in the corresponding
indication
Note 1 to entry: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend
on the value of a quantity being measured.
[SOURCE: ISO/IEC Guide 99:2007, 4.14]
3.4.2
maximum permissible measurement error
extreme value of measurement error, with respect to a known reference quantity value, permitted by
specifications or regulations for a given measurement, measuring instrument, or measuring system
Note 1 to entry: Usually, the term “maximum permissible errors” or “limits of error” is used where there are two
extreme values.
Note 2 to entry: The term “tolerance” should not be used to designate “maximum permissible error”.
[SOURCE: ISO/IEC Guide 99:2007, 4.26]
© ISO 2015 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 14644-1:2016
ISO 14644-1:2015(E)
3.5 Instrument specifications
3.5.1
LSAPC
light scattering airborne particle counter
light scattering discrete airborne particle counter
instrument capable of counting and sizing single airborne particles and reporting size data in terms of
equivalent optical diameter
Note 1 to entry: The specifications for the LSAPC are given in ISO 21501-4:2007.
3.5.2
discrete-macroparticle counter
instrument capable of counting and sizing single airborne macroparticles
Note 1 to entry: See Table F.1 for specifications.
3.5.3
time-of-flight particle sizing apparatus
discrete-particle counting and sizing apparatus that defines the aerodynamic diameter of particles by
measuring the time for a particle to accommodate to a change in air velocity
Note 1 to entry: This is usually done by measuring the particle transit time optically after a fluid stream
velocity change.
Note 2 to entry: See Table F.2 for specifications.
4 Classification
4.1 Occupancy state(s)
The air cleanliness class by particle concentration 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 3.3).
4.2 Particle size(s)
One, or more than one, threshold (lower limit) particle sizes situated within the range from ≥0,1 µm to
≥5 µm are to be used to determine air cleanliness particle concentration for classification.
4.3 ISO Class number
Air cleanliness class by particle concentration shall be designated by an ISO Class number, N. The maximum
permitted concentration of particles for each considered particle size is determined from Table 1.
Particle number concentrations for different threshold sizes in Table 1 do not reflect actual
...
SLOVENSKI STANDARD
oSIST prEN ISO 14644-1:2011
01-april-2011
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO .ODVLILNDFLMDþLVWRVWL]UDNDV
SRPRþMRNRQFHQWUDFLMHGHOFHY ,62',6
Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness by particle concentration (ISO/DIS 14644-1:2010)
Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit
anhand der Partikelkonzentration (ISO/DIS 14644-1:2010)
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la
propreté particulaire de l'air (ISO/DIS 14644-1:2010)
Ta slovenski standard je istoveten z: prEN ISO 14644-1
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-1:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 14644-1:2011
---------------------- Page: 2 ----------------------
oSIST prEN ISO 14644-1:2011
EUROPEAN STANDARD
DRAFT
prEN ISO 14644-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2010
ICS 13.040.35 Will supersede EN ISO 14644-1:1999
English Version
Cleanrooms and associated controlled environments - Part 1:
Classification of air cleanliness by particle concentration
(ISO/DIS 14644-1:2010)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 1:
Partie 1: Classification de la propreté particulaire de l'air Klassifizierung der Luftreinheit anhand der
(ISO/DIS 14644-1:2010) Partikelkonzentration (ISO/DIS 14644-1:2010)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 243.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 14644-1:2010: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
oSIST prEN ISO 14644-1:2011
prEN ISO 14644-1:2010 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14644-1:2011
prEN ISO 14644-1:2010 (E)
Foreword
This document (prEN ISO 14644-1:2010) 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 document is currently submitted to the parallel Enquiry.
This document will supersede EN ISO 14644-1:1999.
Endorsement notice
The text of ISO/DIS 14644-1:2010 has been approved by CEN as a prEN ISO 14644-1:2010 without any
modification.
3
---------------------- Page: 5 ----------------------
oSIST prEN ISO 14644-1:2011
---------------------- Page: 6 ----------------------
oSIST prEN ISO 14644-1:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-1
ISO/TC 209 Secretariat: ANSI
Voting begins on Voting terminates on
2010-12-02 2011-05-02
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness by particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 1: Classification de la propreté particulaire de l'air
[Revision of first edition (ISO 14644-1:1999)]
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 formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, 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 NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2010
---------------------- Page: 7 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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
Case postale 56 • CH-1211 Geneva 20
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 2010 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
Contents Page
1 Scope.1
2 Normative reference.1
3 Definitions .1
4 Classification .4
5 Demonstration of compliance.5
Annex A (normative) Reference method for determination of air cleanliness classification by
particle concentration.8
Annex B (informative) Worked examples of classification calculations.14
Annex C (informative) Considerations for counting and sizing of particles outside the size range
applicable for classification .23
Annex D (informative) Sequential sampling procedure .26
Annex E (informative) Illustration of the ISO cleanliness classes.35
Bibliography.37
© ISO 2010 – All rights reserved iii
---------------------- Page: 9 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
Foreword
This edition is the result of a systematic review and includes changes in response to user and expert feedback
validated by international enquiry. The title has been revised to “Classification of air cleanliness by particle
concentration” to be consistent with other parts of the standard. The nine ISO cleanliness classes are retained
unchanged, but Table 1 defines the particle concentration at various particle sizes for the nine integer classes.
The use of Table 1 ensures better definition of the appropriate particle-size ranges for the different classes. A
formula is retained to allow definition of intermediate decimal classes. The standard retains the concept of
ultrafine and macroparticle descriptors for particle sizes outside the range appropriate for measurement using
airborne particle counters.
The most significant change is the adoption of a more consistent statistical approach to the selection of
number of sample locations and the evaluation of the data collected. The number of sample locations
compared with the 1999 version of the standard have been changed. The approach allows each location to be
treated independently with a 95 % level of confidence that at least 90 % of the cleanroom or clean zone will
comply with the maximum particle concentration limit for the target class of air cleanliness. A reference table is
provided to define the number of sample locations required. Because a degree of randomness is required, the
cleanroom or clean zone is then divided into equal sectors and the sample location placed randomly within
each sector.
Finally, the annexes have been reordered to improve the logic of the standard.
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 14644-1 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces in whole the first edition (ISO 14644-1:1999), which has been
technically revised.
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: Specifications for monitoring and periodic testing to prove continued compliance with ISO
14644-1:XXXX
Part 3: Test methods
iv © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Vocabulary
Part 7: Separative devices (clean air hoods, gloveboxes, isolators, and mini-environments)
Part 8: Classification of airborne molecular contamination
Part 9: Classification of surface cleanliness by particle concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments —
Biocontamination control:
Part 1: General principles and methods
Part 2: Evaluation and interpretation of biocontamination data
© ISO 2010 – All rights reserved v
---------------------- Page: 11 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination of air or surfaces
to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be
beneficial for protection of product or process integrity in applications such as aerospace, microelectronics,
pharmaceuticals, medical devices and healthcare.
This part of ISO 14644 specifies ISO classes of air cleanliness in terms of particle concentration in air volume.
It also specifies the standard method of testing to determine classification, including selection of sampling
locations, and evaluation of class from the data collected.
vi © ISO 2010 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 14644-1:2011
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-1
Cleanrooms and associated controlled environments —
Part 1:
Classification of air cleanliness by particle concentration
1 Scope
This part of ISO 14644 covers the classification of air cleanliness 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) particle sizes ranging from 0,1 µm to 5 µm are
considered for classification purposes.
The use of discrete-particle airborne counting and sizing instruments is the basis for determination of the
concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling
locations.
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 (see 3.3.1 and 3.3.2), respectively.
This part of ISO 14644 cannot be used to characterise the physical, chemical, radiological or viable nature of
airborne particles.
NOTE The actual distribution of particle concentrations within incremental size ranges is normally not predictable and
is typically variable over time.
2 Normative reference
The following normative document contains provisions, which, through reference in this text, constitute
provisions of this part of ISO 14644. Subsequent amendments to or revisions of this publication do not apply.
However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility
of applying the most recent editions of the normative document indicated below.
ISO 21501-4:2007, Determination of particle size distribution — Single particle light interaction methods —
Part 4: Light scattering airborne particle counter for clean spaces
3 Definitions
For the purposes of this part of ISO 14644, the following 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 minimise 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 2010 – All rights reserved 1
---------------------- Page: 13 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
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 minimise 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.
3.1.3
classification
level of air cleanliness by particle concentration applicable to a cleanroom or clean zone, expressed in terms
of an ISO Class N, which represents maximum allowable concentrations expressed as particles per cubic
metre, for particles equal to and greater than the considered sizes
NOTE 1 The maximum allowable concentrations are defined in Table 1 in 4.2 or determined by Equation (1) in 4.2 if
specifying an intermediate decimal class.
NOTE 2 Classification in accordance with this International Standard is limited to the range extending from ISO Class 1
through ISO Class 9.
NOTE 3 The considered particle sizes applicable for classification in accordance with this International Standard are
limited to the range from ≥ 0,1 µm to 5 µm.
NOTE 4 Air cleanliness may be described and specified (but not classified) in terms of U descriptors or M descriptors
(see 3.3.1 or 3.3.2) for considered threshold particle sizes that are outside of the range covered by classification.
NOTE 5 intermediate decimal ISO classification numbers may be specified, with 0,1 being the smallest permitted
increment; i.e. the range of intermediate decimal ISO classes extends from ISO Class 1,1 through ISO Class 8,9.
NOTE 6 Classification may be specified or accomplished in any of three occupancy states (see 3.4).
3.2 Airborne particles
3.2.1
particle
minute piece of matter with defined physical boundaries
3.2.2
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 light-scattering instruments, the equivalent optical diameter is used.
3.2.3
particle concentration
number of individual particles per unit volume of air
3.2.4
particle size distribution
cumulative distribution of particle concentration as a function of particle size
3.2.5
ultrafine particle
particle with an equivalent diameter less than 0,1 µm
3.2.6
macroparticle
particle with an equivalent diameter greater than 5 µm
2 © ISO 2010 – All rights reserved
---------------------- Page: 14 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
3.2.7
unidirectional airflow
controlled airflow through the entire cross-section of a clean zone with a steady velocity and approximately
parallel airstreams
NOTE This type of airflow results in a directed transport of particles from the clean zone.
3.3 Descriptors
3.3.1
U descriptor
measured or specified concentration, in 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 characterise the cleanroom or clean zone). U
descriptors cannot be used to define air cleanliness classes by particle concentration, but they may be quoted
independently or in conjunction with air cleanliness classes by particle concentration.
3.3.2
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 characterise the cleanroom or clean zone). M
descriptors cannot be used to define air cleanliness classes by particle concentration, but they may be quoted
independently or in conjunction with air cleanliness classes by particle concentration.
3.4 Occupancy states
3.4.1
as-built
condition where the cleanroom or clean zone is complete with all services connected and functioning but with
no production equipment, materials or personnel present
3.4.2
at-rest
condition where the cleanroom or clean zone is complete with equipment installed and operating in a manner
agreed upon by the customer and supplier, but with no personnel present
3.4.3
operational
condition where the cleanroom or clean zone is functioning in the specified manner, with the specified number
of personnel present and working in the manner agreed upon
3.5 Roles
3.5.1
customer
organisation, or the agent thereof, responsible for specifying the requirements of a cleanroom or clean zone
3.5.2
supplier
organisation engaged to satisfy the specified requirements of a cleanroom or clean zone
© ISO 2010 – All rights reserved 3
---------------------- Page: 15 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
4 Classification
4.1 Occupancy state(s)
The air cleaniness class by particle concentration 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 3.4).
4.2 Classification number
Air cleanliness class by particle concentration shall be designated by a classification number, N. The
maximum permitted concentration of particles, C , for each considered particle size, D, is determined from
n
Table 1.
Table 1 — Air cleanliness classification table by particle concentration
3
ISO Maximum allowable concentrations (particles/m ) for particles equal to and
a
classification
greater than the considered sizes shown below
number (N)
0,1 µm 0,2 µm 0,3 µm 0,5 µm 1 µm 5 µm
b
d d d d e
ISO Class 1
10
b b
d d e
ISO Class 2 100
24 10
b
d e
ISO Class 3 1 000 237 102
35
b
e
ISO Class 4 10 000 2 370 1 020 352
83
e
ISO Class 5 100 000 23 700 10 200 3 520 832
ISO Class 6 1 000 000 237 000 102 000 35 200 8 320 293
c c c
ISO Class 7 352 000 83 200 2 930
c c c
ISO Class 8 3 520 000 832 000 29 300
c c c
ISO Class 9 35 200 000 8 320 000 293 000
a
All concentrations in the table are cumulative, e.g. for ISO Class 5, the 10 200 particles shown at 0,3 µm include
all particles equal to and greater than this size.
b
These concentrations will lead to large air sample volumes for classification. Sequential sampling procedure
may be applied; see Annex D.
c
Concentration limits are not applicable in this region of the table due to very high particle concentration.
d
Sampling and statistical limitations for particles in low concentrations make classification inappropriate.
e
Sample collection limitations for both particles in low concentrations and sizes greater than 1 μm make
classification inappropriate, due to potential particle losses in the sampling system.
A representation of the selected classes in graphical form is provided in Figure E.1 (see Annex E).
Equation (1), below, shall be used to determine the maximum particle concentration for intermediate decimal
classes at the considered particle size:
0,1
N 2,08
Cn = 10 ( ) (1)
D
where
C is the maximum permitted concentration (particles per cubic metre) of airborne particles that are
n
equal to and greater than the considered particle size. C is rounded to the nearest whole number, using no
n
more than three significant figures.
4 © ISO 2010 – All rights reserved
---------------------- Page: 16 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
N is the ISO classification number, which shall not exceed a value of 9 or be less than 1. Intermediate
decimal ISO classification numbers may be specified, with 0,1 being 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 E.1 (see Annex E) provides examples of intermediate decimal classes. The associated notes to Table
E.1 identify restrictions due to sampling and collection limitations.
4.3 Designation
The designation of airborne particle concentration for cleanrooms 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 class limit(s), as determined by the classification table
(Table 1) or Equation (1) where each considered lower threshold particle size is in the range from 0,1 µm
through 5 µm.
The considered particle size(s) for which the concentration(s) will be measured shall be agreed upon by the
customer 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), i.e. D2 ≥ 1,5 D1.
Example designations:
ISO Class 4; at rest; 0,2 µm 0,5 µm
ISO Class 7,5; in operation; 0.5 µm
5 Demonstration of compliance
5.1 Principle
Compliance with air cleanliness (ISO class) requirements specified by the customer is verified by performing
specified testing procedures and by providing documentation of the results and conditions of testing, as
agreed upon by the customer and the supplier.
5.2 Testing
The reference test method for demonstrating compliance is given in Annex A (normative). Alternative methods
or instrumentation (or both), having at least comparable performance, may be specified. If no alternative is
specified or agreed upon, the reference method shall be used.
Tests performed to demonstrate compliance shall be conducted using calibrated instruments.
5.3 Airborne particle concentration evaluation
Upon completion of testing in accordance with 5.2, the concentration of particles (expressed as number of
particles per cubic metre) in the single sample volume at each sample location shall not exceed the
concentration limit(s) given in Table 1 or derived from Equation (1) for intermediate decimal classes for the
considered size(s). If multiple single sample volumes are taken at a sample location, the concentration shall
© ISO 2010 – All rights reserved 5
---------------------- Page: 17 ----------------------
oSIST prEN ISO 14644-1:2011
ISO/DIS 14644-1
be averaged and the average concentration must not exceed the concentration limits given in Table 1 or
derived from Equation (1) for intermediate decimal classes.
Particle concentrations used for determination of conformance to classification limits shall be measured by the
same method for all considered particle sizes.
5.4 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 non-compliance with the specified designation of air
cleanliness class by particle concentration.
The test report shall include:
a) the name and address of the testing organisation, and the date on which the test was performed;
b) the number and year of publication of this part of ISO 14644, i.e. ISO 14644-1:date of current issue;
c) a clear identification of the physical location of the cleanroom or clean zo
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.