SIST EN ISO 14644-8:2014

SLOVENSKI STANDARD
SIST EN ISO 14644-8:2014
01-januar-2014
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Cleanrooms and associated controlled environments - Part 8: Classification of air
cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifizierung der Luftreinheit
anhand der Chemikalienkonzentration (ACC) (ISO 14644-8:2013)
Salles propres et environnements maîtrisés apparentés - Partie 8: Classification de la
propreté chimique de l'air (ISO 14644-8:2013)
Ta slovenski standard je istoveten z: EN ISO 14644-8:2013
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-8:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-8:2014

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SIST EN ISO 14644-8:2014


EUROPEAN STANDARD
EN ISO 14644-8

NORME EUROPÉENNE

EUROPÄISCHE NORM
February 2013
ICS 13.040.35 Supersedes EN ISO 14644-8:2006
English Version
Cleanrooms and associated controlled environments - Part 8:
Classification of air cleanliness by chemical concentration (ACC)
(ISO 14644-8:2013)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 8:
Partie 8: Classification de la propreté chimique de l'air (ISO Klassifizierung der Luftreinheit anhand der
14644-8:2013) Chemikalienkonzentration (ACC) (ISO 14644-8:2013)
This European Standard was approved by CEN on 9 February 2013.

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

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-8:2013: E
worldwide for CEN national Members.

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SIST EN ISO 14644-8:2014
EN ISO 14644-8:2013 (E)
Contents Page
Foreword . 3
2

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SIST EN ISO 14644-8:2014
EN ISO 14644-8:2013 (E)
Foreword
This document (EN ISO 14644-8:2013) 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
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 14644-8:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, 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 14644-8:2013 has been approved by CEN as EN ISO 14644-8:2013 without any modification.

3

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SIST EN ISO 14644-8:2014

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SIST EN ISO 14644-8:2014
INTERNATIONAL ISO
STANDARD 14644-8
Second edition
2013-02-15
Cleanrooms and associated controlled
environments —
Part 8:
Classification of air cleanliness by
chemical concentration (ACC)
Salles propres et environnements maîtrisés apparentés —
Partie 8: Classification de la propreté chimique de l’air
Reference number
ISO 14644-8:2013(E)
©
ISO 2013

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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
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
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
Published in Switzerland
ii © ISO 2013 – All rights reserved

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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(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 Contaminant categories . 2
4 Classification . 3
4.1 General . 3
4.2 ISO-ACC descriptor format . 3
5 Demonstration of compliance . 5
5.1 Principle . 5
5.2 Testing . 5
5.3 Test report . 6
Annex A (informative) Parameters for consideration . 7
Annex B (informative) Typical contaminants .11
Annex C (informative) Typical methods of measurement .15
Annex D (informative) Consideration of specific requirements for separative devices .19
Bibliography .21
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(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 14644-8 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: Test methods
— Part 4: Design, construction and start‑up
— Part 5: Operations
— Part 6: Vocabulary
— Part 7: Separative devices (clean air hoods, gloveboxes, isolators, 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
This second edition cancels and replaces the first edition (ISO 14644-8:2006), which has been
technically revised.
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(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, healthcare, optics, instrumentation,
vacuum technology, coatings, photovoltaics, displays, LEDs, coatings, automotive and surface analysis.
In some of these industries, the product or process can be sensitive to, or can be destroyed by, chemical
contamination resulting from chemicals that are present due to external, process, or otherwise
generated sources.
Within this part of ISO 14644, the presence of chemicals is expressed as air chemical contamination.
Chemical contamination is a three-step event. The first step is generation due to external sources such
as process leakage or construction material or personnel or material outgassing. The second step is
transport as airborne chemical contamination. The third step is sorption on the sensitive surface, which
can be quantified as a surface chemical contamination.
The generating materials and the surfaces where sorption takes place will have a large influence on
the steps of generation and sorption in addition to the actual air contamination. Thus, for these two
steps, not only the contaminants but also the involved bulk and surfaces need to be defined. In order to
make a standard generally applicable to any type of cleanroom or associated controlled environment,
air chemical cleanliness (ACC) has been chosen for the classification.
This part of ISO 14644 assigns ISO classification levels to be used to specify the level of ACC within a
cleanroom and associated controlled environment, where the product or process is deemed to be at risk
from air chemical contamination.
For classification purposes, this part of ISO 14644 is limited to a designated range of ACC and provides
standard protocols for specifying such levels with regard to chemical compounds, methods of test and
analysis, and time weighted factors.
Informative annexes are contained in this part of ISO 14644 covering:
— parameters for consideration: Annex A;
— typical contaminating chemicals and substances: Annex B;
— typical methods of measurement and analysis: Annex C;
— considerations of specific requirements for separative devices: Annex D.
This part of ISO 14644 is one of a series of standards concerned with cleanrooms and contamination
control. Many factors besides ACC need to be considered in the design, specification, operation and
control of cleanrooms and other controlled environments. These are covered in some detail in other
[4]
parts of the International Standards prepared by ISO/TC 209, including ISO 14698 (all parts). In some
circumstances, relevant regulatory agencies can impose supplementary policies or restrictions. In such
situations, appropriate adaptations of this part of ISO 14644 can be required.
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SIST EN ISO 14644-8:2014
INTERNATIONAL STANDARD ISO 14644-8:2013(E)
Cleanrooms and associated controlled environments —
Part 8:
Classification of air cleanliness by chemical
concentration (ACC)
1 Scope
This part of ISO 14644 establishes the classification of air chemical cleanliness (ACC) in cleanrooms
and associated controlled environments, in terms of airborne concentrations of specific chemical
substances (individual, group or category) and provides a protocol to include test methods, analysis and
time-weighted factors within the specification for classification.
This part of ISO 14644 currently considers only concentrations of air chemical contaminants between
0 −12 3
10 and 10 g/m under cleanroom operational conditions.
This part of ISO 14644 is not relevant for application in those industries, processes or productions where
the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of this part of ISO 14644 to describe the nature of air chemical contaminants.
This part of ISO 14644 does not give a classification of surface chemical contamination.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 14644-6, Cleanrooms and associated controlled environments — Part 6: Vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14644-6 and the following apply.
3.1 General
3.1.1
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
3.1.2
air cleanliness by chemical concentration
ACC
level of air cleanliness by chemical concentration, expressed in terms of an ISO-ACC Class N, which
represents the maximum allowable concentration of a given chemical species or a group of chemical
species, expressed in grams per cubic metre
Note 1 to entry: This definition does not include macromolecules of biological origin, which are judged to be particles.
3.1.3
air chemical contamination
any substance in the air that can, by its chemical nature, adversely affect the product, process or equipment
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(E)

3.1.4
surface cleanliness by chemical concentration
SCC
condition of the surface cleanliness with respect to its chemical concentration
3.1.5
surface chemical contamination
any substance on the surface that can, by its chemical nature, adversely affect the product, process or
equipment
3.1.6
contaminant category
common name for a group of compounds with a specific and similar deleterious effect when deposited
on the surface of interest
3.1.7
outgassing
release of chemical substances in the gaseous or vapour state from a material
3.1.8
air cleanliness by chemical concentration (ACC) class
grading number stating the maximum allowable concentration of a given chemical species or a group of
chemical species in grams per cubic metre
Note 1 to entry: The maximum allowable concentrations are defined in Table 1 or determined by the equation
for N in 4.2.
Note 2 to entry: Classification in accordance with this part of ISO 14644 is limited to the range from 0 (the class
with the lowest allowable cleanliness) to –12 (the cleanest specified class).
Note 3 to entry: The ACC class number is only valid in connection with the ACC descriptor that specifies to which
chemical species or group of chemical species it is related.
Note 4 to entry: The negative sign of the air chemical cleanliness classes (–1 to –12) is an integral part of the ACC
class number N and must always be given. An air chemical cleanliness class without the negative sign (with the
exception of the class 0) is not allowed.
Note 5 to entry: Intermediate ISO classification numbers may be specified, with 0,1 being the smallest
permitted increment.
3.2 Contaminant categories
3.2.1
acid
substance whose chemical reaction characteristic is to establish new bonds by the acceptance of
electron pairs
3.2.2
base
substance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs
3.2.3
biotoxic
contaminant substance that is obnoxious to the development and preservation of the life of organisms,
microorganisms, tissues or individual cells
3.2.4
condensable
substance capable of depositing on a surface by condensation under cleanroom operating conditions
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ISO 14644-8:2013(E)

3.2.5
corrosive
substance that causes destructive chemical change of a surface
3.2.6
dopant
substance that, after sorption and/or diffusion, is incorporated in the bulk of a product and is capable of
changing the properties of materials, even in trace amounts
3.2.7
organic
species based on carbon-containing compounds
Note 1 to entry: Inorganic carbon-containing compounds are excluded.
3.2.8
oxidant
substance that, upon deposition onto a surface or product of interest, results in the formation of an oxide
or participates in a redox reaction
4 Classification
4.1 General
Classification shall be specified by use of a classification descriptor as described in 4.2. This descriptor
is designated “ISO-ACC” and specifies the maximum total chemical concentration permitted for a
contaminant category, an individual substance or a group of substances.
4.2 ISO-ACC descriptor format
An ACC class number is only valid in connection with the ACC descriptor that specifies the chemical
substance or group of substances for which this class number is valid. The ISO–ACC descriptor is
expressed in the format:
ISO-ACC Class N (X)
where:
X is a chemical substance or a group of chemical substances which includes, but is not limited to:
acid (ac),
base (ba),
biotoxic (bt),
condensable (cd),
corrosive (cr),
dopant (dp),
organic, total (or),
oxidant (ox),
or a group of substances or an individual substance;
N is the ISO-ACC class, which is the logarithmic index of concentration, c , expressed in grams
x
per cubic metre, and falls within a limiting range of 0 to −12. Intermediate concentrations may be
specified, with 0,1 being the smallest permitted increment of N;
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ISO 14644-8:2013(E)

N = log [c ].
10 x
EXAMPLE 1 With an N-Methyl Pyrrolidone (NMP) sample, the measured value of air contamination was
3 3
8E-7 g/m ; N = -6,097. This is within the class limit of 1E-6 g/m for Class −6. The designation would be:
“ISO-ACC Class −6 (NMP)”.
3
EXAMPLE 2 With an organic compound sample, the measured value was 6E-5 g/m of total organic compounds
3
(TOC). This is within the class limit of 1E-4 g/m for Class −4. The designation would be: “ISO-ACC Class −4 (TOC).”
Table 1 and Figure 1 further illustrate the ISO-ACC classification as a function of contaminant
concentration.
Table 1 — ISO-ACC classes
Concentration Concentration Concentration
ISO-ACC class
3 3 3
g/m µg/m ng/m
0 6 9
0 10 10 (1 000 000) 10 (1 000 000 000)
−1 5 8
−1 10 10 (100 000) 10 (100 000 000)
−2 4 7
−2 10 10 (10 000) 10 (10 000 000)
−3 3 6
−3 10 10 (1 000) 10 (1 000 000)
−4 2 5
−4 10 10 (100) 10 (100 000)
−5 1 4
−5 10 10 (10) 10 (10 000)
−6 0 3
−6 10 10 (1) 10 (1 000)
−7 −1 2
−7 10 10 (0,1) 10 (100)
−8 −2 1
−8 10 10 (0,01) 10 (10)
−9 −3 0
−9 10 10 (0,001) 10 (1)
−10 −4 −1
−10 10 10 (0,000 1) 10 (0,1)
−11 −5 −2
−11 10 10 (0,000 01) 10 (0,01)
−12 −6 −3
−12 10 10 (0,000 001) 10 (0,001)
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(E)

Y
X
1
X
2
X
3
Key
3
X airborne concentration (g/m )
1
3
X airborne concentration (µg/m )
2
3
X airborne concentration (ng/m )
3
Y ISO-ACC class
Figure 1 — ISO-ACC classes as a function of concentration
5 Demonstration of compliance
5.1 Principle
Compliance with classification (ISO-ACC class) requirements specified by the customer is verified by
performing specified testing procedures agreed between the customer and supplier and by providing
specified documentation of the results and conditions of testing.
5.2 Testing
Example test methods are given in Annex C. The list of typical methods described is not exhaustive.
Alternative methods of comparable accuracy may be specified by agreement.
NOTE 1 Analysis by different methods, even when correctly applied, can produce different results of equal validity.
Tests performed to demonstrate compliance shall be conducted using suitable test methods and
calibrated instruments.
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(E)

Sampling locations shall be determined by agreement between the customer and supplier.
It is recommended to carry out replicate sampling at the locations agreed.
NOTE 2 In analytical measurement, the contribution of particulate contamination cannot always be excluded.
NOTE 3 For trace analysis using grab sampling, the incorporation of a shipping blank sample, prepared and
analysed in the same batch as the actual sample, is required to assess contamination from the overall process,
except the air sampling.
The elapsed time period shall be agreed between the customer and supplier. See A.4.3.
5.3 Test report
The results from testing each cleanroom or associated controlled environment shall be recorded and
submitted as a comprehensive report, along with a statement of compliance or non-compliance with the
specified ISO-ACC class(es).
The test report shall include the following:
a) name of the test operator, the name and address of the testing organization, and the date, time and
duration of sampling;
b) number and year of publication of this part of ISO 14644, i.e. ISO 14644-8:2013;
c) clear identification of the physical location of the cleanroom or controlled environment tested
(including reference to adjacent areas if necessary) and specific designations for coordinates of all
sampling locations;
d) specified designation criteria for the cleanroom or controlled environment, including the occupancy
state, the ISO-ACC class or classes, the specified test method(s) and, where applicable, the substances,
substance group or category(ies), the elapsed time period and the designated particulate class;
e) details of the test procedure used, with any available data describing the test circumstances
or departures from the test method, and identification of the test instrument(s) and its current
calibration certificate(s);
f) test results, including air chemical concentration(s) data, for all sampling locations.
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SIST EN ISO 14644-8:2014
ISO 14644-8:2013(E)

Annex A
(informative)

Parameters for consideration
A.1 Principles
This annex is intended to give guidance to consideration of parameters affecting or contributing to ACC
within a cleanroom or associated controlled environment. It is important to consider the development
of such parameters at the initial stages of design and control requirements, along with any special
considerations for operation of the facility.
A.2 Concepts for establishing parameters
The following principles permit the establishment of the parameters which influence the ACC or which
contribute to it and which should be taken into account.
a) First, establish if the product or process is affected by chemical contamination, as in many industries
consideration of chemical contamination is not a governing factor.
b) Establish the contaminant categories that affect the product or process and if any particular
substances or substance groups require special consideration.
c) Establish the maximum concentrations of contaminant categories and/or substances or substance
groups permitted for the product or process and designate the associated ISO-ACC descriptor in
accordance with 4.2.
d) Establish sources of chemical contamination and concentration levels that can occur from
1) outdoor air (providing fresh air to the facility);
2) construction materials in the facility, especially those in contact with recirculating and make-
up air streams;
3) cross-contamination that can occur within the facility;
4) operation and maintenance of the facility;
5) personnel, cleanroom apparel and auxiliary materials;
6) process media and tooling.
Further guidance on these occurrences is given in A.3 to A.8.
e) Establish the design requirements to avoid or reduce chemical contamination generated as per
A.2 d) to achieve the ISO-ACC class for the product or process.
A.3 Outdoor air
A.3.1 Where outdoor air is provided as fresh air to the facility to which the product or process is exposed,
the outdoor air quality and any seasonal variation should be established with regard to the concentration
of compounds or substances affecting the product or process. In addition, the construction materials of
heating, ventilation or air conditioning equipment, including cabling, should be taken into account.
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A.3.2 The analysis of the concentration should be conducted over a period of time sufficient to evaluate
its variability, along with consideration of any future developments that can affect the outdoor air quality.
A.3.3 In some cases, due to prevailing winds, proximity of contaminating sources, etc., chemical contamination
concentrations can be minimized by selective positioning of the fresh-air intake(
...