Spanish Standard

UNE UNE-EN ISO 14644-8

Spanish February 2023
standardizatio
n

Clean rooms and controlled annexes

Part 8: Air cleanliness assessment by chemical
concentration
(ISO 14644-8:2022)

This standard has been developed by the technical committee

CTN-UNE 100 Air Conditioning, whose secretariat is held by AFEC.

Spanish Association for Standardization 915 294 900

Genoa Street, 6 28004 Madrid. Spain o@une.org – www.une.org

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 UNE-EN ISO 14644-
8
Clean rooms and controlled annexes
Part 8: Air cleanliness assessment by chemical concentration
(ISO 14644-8:2022)
Cleanrooms and associated controlled environments. Part 8: Assessment of air cleanliness by chemical
concentration (ACC) (ISO 14644-8:2022).

Salles propres et environnements maîtrisés apparentés. Partie 8: Evaluation of air chemical properties (ISO
14644-8:2022).

This standard is the official version, in Spanish, of the European Standard EN ISO 14644-8:2022,
which in turn adopts the International Standard ISO 14644-8:2022.

This standard cancels and replaces Standard UNE-EN ISO 14644-8:2014.

Comments on this document should be directed to:

Spanish Association for Standardization

Genoa, 6
28004 MADRID-Spain
Tel.: 915 294 900
info@une.org
www.une.org

© UNE 2023
Reproduction prohibited without consent of UNE.
All intellectual property rights of this standard are owned by UNE.

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UNE
EUROPEAN STANDARD
EUROPEAN STANDARD
EN ISO 14644-8
NORME EUROPÉENNE
EUROPÄISCHE NORM July 2022

ICS 13.040.35 Replaces EN ISO 14644-8:2013

Spanish version

Clean rooms and controlled annexes

Part 8: Evaluation of air cleanliness by chemical
concentration(ISO 14644-8:2022)

Cleanrooms and associated controlled Salles propres et environnements Reinräume und zugehörige
environments. Part 8: Assessment of air maîtrisés apparentés. Partie 8: Reinraumbereiche. Teil 8:
cleanliness by chemical concentration Evaluation of air chemical Klassifizierung der Luftreinheit anhand
(ACC) (ISO 14644-8:2022). properties (ISO 14644-8:2022). der Chemikalienkonzentration (ACC)
(ISO 14644-8:2022).
This European standard was approved by CEN on 2022-06-04.

CEN members are subject to the CEN/CENELEC Internal Regulations which define the conditions under
which the European standard must be adopted without modification as a national standard. The
corresponding updated lists and bibliographical references relating to these national standards can be
obtained from the CEN/CENELEC Management Centre, or from its members.

This European standard exists in three official versions (German, French and English). A version in
another language produced under the responsibility of a CEN member in its national language and
notified to the CEN/CENELEC Management Centre has the same status as the former.

CEN members are the national standards bodies of the following countries: 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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION

European Committee for StandardizationComité
Européen de NormalisationEuropäisches
Komitee für Normung
MANAGEMENT CENTRE: Rue de la Science, 23, B-1040 Brussels, Belgium

© 2022 CEN. Reproduction rights reserved to CEN Members.

Index

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 UNE-EN ISO 14644-
8
Spanish Standard...................................................................................................................................1
UNE-EN ISO 14644-8...........................................................................................................................1
0 Introduction.........................................................................................................................................6
1 Object and field of application.......................................................................................................7
2 Rules for consultation.....................................................................................................................7
3 Terms and definitions.....................................................................................................................7
3.1 Generalities.............................................................................................................................7
3.2 Categories of pollutants..........................................................................................................8
4 Testing and control using classification levels...............................................................................9
4.1 Generalities.............................................................................................................................9
4.2 ISO-ACC descriptor format....................................................................................................9
5 Demonstration of conformity with an ISO-ACC level.....................................................................12
5.1 Principle................................................................................................................................12
5.2 Rehearsal...............................................................................................................................12
5.3 Essay report...........................................................................................................................13

European Prologue

The text of EN ISO 14644-8:2022 has been prepared by Technical Committee ISO/TC 209 Cleanrooms
and associated controlled environments in collaboration with Technical Committee CEN/TC 243
Cleanroom technology, of which BSI acts as Secretariat.

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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN is not responsible for identifying any such patent rights.

This standard cancels and replaces EN ISO 14644-8:2013.

Any comments or questions regarding this document should be directed to the user's national
standards body. A complete list of these organisations can be found on the CEN website.

According to the Internal Regulations of CEN/CENELEC, the standards organisations of the following
countries are required to adopt this European Standard: 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, Republic of North
Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

Statement

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The text of ISO 14644-8:2022 has been approved by CEN as EN ISO 14644-8:2022 without any
modification.

Prologue

ISO (International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of developing 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, both governmental and non-governmental, linked to ISO are also involved 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 planned for its subsequent maintenance are
described in Part 1 of the ISO/IEC Directives. In particular, note should be taken of the different
approval criteria required for different types of ISO documents. This document has been prepared in
accordance with the editorial rules of Part 2 of the ISO/IEC Directives (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 this document will be set out in the Introduction
and/or in the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information provided for convenience and does not constitute
a recommendation.

For an explanation of the voluntary nature of standards, the meaning of ISO-specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles regarding Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.

This document has been prepared by Technical Committee ISO/TC 209, Cleanrooms and associated
controlled environments, in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 243, Cleanroom technology, under the technical cooperation agreement
between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 14644-8:2013) which has been
technically revised. The main changes compared to the previous edition are as follows:

– the term class (classification, classified) has been changed to grade or evaluation as appropriate;
– the definition in section 3.1.2 has been revised;
– the Bibliography has been updated;
– minor editorial changes have been made.

A listing of all parts of the ISO 14644 series of standards can be found on the ISO website.

Any comments or questions regarding this document should be directed to the user's national
standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

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 UNE-EN ISO 14644-
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0 Introduction
Clean rooms and controlled annexes allow for the control of contamination by suspended particles at
levels of cleanliness suitable for carrying out all activities sensitive to a range of contaminants. Products
and processes that benefit from airborne particulate contamination control include, but are not limited
to, aerospace, microelectronics, pharmaceuticals, medical devices, agri-food, healthcare, optics,
instrumentation, vacuum technology, coatings, photovoltaics, displays, LEDs, automotive and surface
analysis.

In some of these industries, the product or process may be sensitive to, or may be destroyed by,
chemical contamination resulting from chemicals present due to external processes or generated by
other sources.

Within this document, the presence of chemicals is expressed as airborne chemical contamination
(ACC). This chemical contamination occurs in three phases. The first phase is the generation due to
external sources, such as a process leak, outgassing of construction material or human emanation. The
second phase is transport as chemical pollution in the air. The third phase is the absorption on the
sensitive surface, which can be quantified in the form of surface chemical contamination.

The generating materials and the surfaces on which absorption occurs will have a major influence on
the generation and absorption phases as well as the actual air pollution. For these two phases, it is
necessary to define not only the contaminants but also the volume and surfaces concerned. In order to
develop a standard that can be applied in a general way to all types of cleanrooms or controlled
annexes, Air Chemical Cleanliness (ACC) has been chosen for the level assessment.

This document designates the ISO classification levels to be used to specify the level of ACC in a
cleanroom and an attached controlled room, when the product or process is considered to be a risk for
chemical contamination of the air.

For the purposes of assessment, this document provides guidance for a range of ACC levels and
provides standardized protocols for specifying these concentrations with respect to chemical
constituents, test and analysis methods, and time weighting factors.

Annexes A to D include the following information:

– the parameters to be taken into account: Annex A;

– typical chemical substances and pollutants: Annex B;

– typical measurement and analysis methods: Annex C;

– considerations of specific requirements for separation devices: Annex D.

This document is part of a series of standards relating to cleanrooms and contamination control. Many
factors along with ACC need to be considered in the design, specification, operation and control of
cleanrooms and other controlled environments. These features are identified in this document and are
covered in more detail in other parts of international standards developed by Technical Committee
ISO/TC 209, including the ISO 14698 series of standards. In some situations, regulatory bodies may
impose additional policies or restrictions. In such situations, appropriate adaptations of this document
may be necessary.

NOTE When chemical air cleanliness (CAC) assessment at critical control points is used as additional cleanliness attributes to
the particulate air cleanliness classification in accordance with ISO 14644-1, the space may be described as a
cleanroom or clean zone. If only ACC is used, the space must be described as a controlled zone.

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1 Object and field of application
This document establishes the typical evaluation processes to determine the levels of chemical air
cleanliness (ACC) classification in cleanrooms and controlled surrounding areas, in terms of suspended
concentrations of specific chemical substances (individual, group, or category) and provides a protocol
that allows the integration of test methods, analysis and time-weighting factors for their determination.
This document currently only considers concentrations of chemical contaminants in air between 100
g/m3 and 10-12 g/m3 under cleanroom operating conditions.

This document is not relevant for application in industries, production processes, where the presence
of suspended chemicals is not considered a risk to the product or process.

It is not the intention of this document to describe the nature of chemical air pollutants.

This document does not provide a classification of surface chemical contamination.

2 Rules for consultation

There are no rules for consultation in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply:

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

– ISO online search platform: available at http://www.iso.org/obp

– IEC Electropedia: available at http://www.electropedia.org/

3.1 Generalities

3.1.1 chemical contamination:

Non-particulate substances that may have a detrimental effect on the product, process or equipment.

3.1.2 air cleaning by chemical concentration, ACC:

Quantity of chemicals detected in the air, expressed in terms of an ISO-ACC N level, which represents
the maximum permissible concentration of a given chemical species or group of chemical species,
expressed in grams per cubic meter.

NOTE 1 This definition does not include macromolecules of biological origin, which are considered as particles.

3.1.3 chemical air pollution:

Any substance in the air that can, by its chemical nature, adversely affect the product, process or
equipment.

3.1.4 surface cleaning by chemical concentration, SCC:

Surface cleanliness condition based on its chemical concentration.

3.1.5 surface chemical contamination:

Any substance on the surface that may, by its chemical nature, adversely affect the product, process or
equipment.

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 UNE-EN ISO 14644-
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3.1.6 pollutant category:
Common name for a group of components with a specific and similar harmful effect when deposited on
the surface of interest.

3.1.7 degassing:
Release of chemicals from the material, in a gaseous or vapor state.

3.1.8 air cleanliness level by chemical concentration class:

Classification number indicating the maximum permissible concentration of a given chemical species or
group of chemical species, expressed in grams per cubic meter.

NOTE 1 The concentration range is defined in Table 1 or determined by the formula for N in section 4.2.

NOTE 2 Testing and control in accordance with this document is limited to the range from 0 (the degree with minimum
cleanliness) to -12 (the level of maximum cleanliness).

NOTE 3 The ACC classification number is valid only in relation to the ACC descriptor that specifies which chemical species or
group of chemical species it refers to.

NOTE 4 The negative sign for chemical air cleaning levels (-1 to -12) is an integral part of the ACC level N number and must
always be used.

NOTE 5 Intermediate ISO grade numbers may be specified, with 0.1 being the minimum possible increment.

3.2 Categories of pollutants

3.2.1 acid:
A substance whose chemical reaction characteristic is to establish new bonds by accepting electron
pairs.

3.2.2 base:
A substance whose chemical reaction characteristic is to establish new bonds by donating electron
pairs.

3.2.3 biotoxic:
Contaminating substance that is repellent to the development and conservation of life of organisms,
microorganisms, tissues or individual cells.

3.2.4 condensable:
Substance capable of being deposited on a surface by condensation under the operating conditions of a
clean room.

3.2.5 corrosive:
Substance that causes destructive chemical changes on a surface.

3.2.6 doping:
Substance that, after absorption and/or diffusion, is incorporated into the volume of a product and is
capable of modifying the properties of materials, even in the trace state.

3.2.7 organic:
Species based on carbon-containing compounds.

NOTE 1 Inorganic compounds containing carbon are excluded.

3.2.8 oxidizing agent:

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Substance that, once deposited on the surface or product of interest, produces the formation of an oxide
(O2/O3) or participates in a redox reaction.

4 Testing and control using classification levels

4.1 Generalities
The test and control must be specified using a descriptor as described in section 4.2. This descriptor is
designated by "ISO-ACC" and indicates the maximum total maximum chemical concentration for a
contaminant category, an individual substance or a group of substances.

4.2 ISO-ACC descriptor format

An ACC classification number is valid only in connection with the ACC descriptor that specifies the
chemical substance or group of substances for which the tier number is valid. The ISO-ACC descriptor is
expressed in the format:

ISO-ACC Level N (X)

where

X is a chemical or group of chemicals including, but not limited to:

– acids (aq);

– bases (ba);

– biotoxic (bt);

– condensable (cd);

– corrosives (cr);

– doping agents (dp);

– total organic (or);

– oxidants (ox); or

– to a group of substances or an individual substance.

N is the ISO-ACC level, which is the logarithmic index of concentration, cX, expressed in grams per cubic
meter, within a limited range of 0 to -12. Intermediate concentrations can be specified, with 0.1
being the minimum possible increase in N;

N = log10 [cX].

EXAMPLE 1 With a sample of N-methylpyrrolidone (NMP), the measured value of air pollution was 8E-7 g/ m3; N =
–6,097. This value is within the level limit of 1E-6 g/ m3 for grade –6. The designation would be: "ISO–
ACC Level -6 (NMP)".

EXAMPLE 2 With a sample of organic compound the measured value was 6E-5 g/ m3 of total organic compounds
(TOC, Total Organic Compounds). This value is within the level limit of 1E-4 g/ m3 for grade –4. The
designation would be: "ISO–ACC Level –4 (TOC)".

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 UNE-EN ISO 14644-
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Table 1 and Figure 1 provide a complementary illustration of suggested ISO-ACC concentration levels
based on the contaminant concentration for the specified species.

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 - 11 - UNE-EN ISO 14644-8:2023

Table 1 – ISO-ACC Grades

ISO-ACC level Concentration g/m3 Concentration µg/m3 Concentration ng/m3

0 100 106 (1 000 000) 109 (1 000 000 000)

-1 10 -1 105 (100 000) 108 (100 000 000)
-2 10-2 104 (10 000) 107 (10 000 000)
-3 10 -3 103 (1 000) 106 (1 000 000)
-4 10-4 102 (100) 105 (100 000)
-5 10-5 101 (10) 104 (10 000)
-6 10 -6 100 (1) 103 (1 000)
-7 10-7 10-1 (0,1) 102 (100)
-8 10 -8 10-2 (0,01) 101 (10)
-9 10-9 10-3 (0,001) 100 (1)
-10 10-10 10-4 (0,000 1) 10-1 (0,1)
-11 10-11 10-5 (0,000 01) 10-2 (0,01)
-12 10-12 10-6 (0,000 001) 10-3 (0,001)

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UNE-EN ISO 14644-8:2023 - 12 -
ug/m3)
m3
X3 Suspended concentration (ng/ )

Legend
X1 Suspension concentration (g/m3)
X2 Suspension concentration (
AND ISO-ACC level

Figure 1 – ISO-ACC levels as a function of concentration

5 Demonstration of conformity with an ISO-ACC level

5.1 Principle
Compliance with a customer-specified ISO-ACC level requirement is verified by carrying out the tests
defined and agreed between the customer and supplier, providing the specified documentation relating
to the results and test conditions.

5.2 Rehearsal
Examples of test methods are given in Annex C. The list of typical methods described is not exhaustive.
Alternative methods with comparable accuracy may be specified by agreement.
NOTE 1 An analysis carried out by different methods, even correctly applied, may give different results of equivalent validity.

Tests performed to demonstrate conformity must be carried out using appropriate test methods and

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 - 13 - UNE-EN ISO 14644-8:2023

calibrated instruments.

The location of the samples must be agreed between the client and the supplier.

It is recommended that double sampling be carried out at the agreed points.

NOTE 2 In an analytical measurement, the contribution of particulate contamination cannot always be excluded.

NOTE 3 For trace analysis using capture sampling, the incorporation of an unused shipping sample, prepared and analyzed in
the same batch as the actual sample, is required to assess contamination of the overall process, excluding air
sampling.

The time periods elapsed must be agreed between the customer and the supplier. See section A.4.3.

5.3 Essay report

The results of testing for each cleanroom or associated controlled facility shall be recorded and
presented in a comprehensive report, with a statement of conformity or non-conformity with the
specified ISO-ACC levels.

The test report should include the following:

a) name of the operator, the name and address of the body carrying out the test and the date, time
and duration of sampling;

b) number and year of publication of this document, i.e. ISO Standard 14644-8:2022;

c) clear identification of the physical location of the cleanroom and controlled annex tested (including
reference to adjacent areas if necessary) and specific designation by coordinates of all locations of
our intakes;

d) specific designation criteria for the cleanroom or attached controlled facility, including occupancy
status, ISO-ACC levels, specified methods, and if applicable, the substances, group of substances or
categories, elapsed time period, and particle type designated;

e) details of the test procedure used, stating all available data describing the circumstances of the test
or deviations from the test method, and identification of the test instruments and up-to-date
calibration certificates;

f) test results, including airborne chemical concentration data, for all sampling locations.

Annex A (Informative)

Parameters to take into consideration

A.1 Principles
This annex is intended to provide guidance on parameters to be considered that affect or contribute to
ACC in a cleanroom or controlled annex. It is important to consider the development of these
parameters in the initial design and requirements control phases, with special consideration to those
related to operation and installation.

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UNE-EN ISO 14644-8:2023 - 14 -

A.2 Principles for establishing parameters

The following principles help to establish the parameters that affect or contribute to ACC and that
should be taken into account.

a) First, it is established whether the product or process is affected by chemical contamination,

because in many industries the consideration of chemical contamination is not a determining
factor.

b) The categories of contaminants that affect the product or process are established and whether any
substance or group of substances need special considerations.

c) The maximum concentrations of the categories of contaminants and/or substances or groups of

substances permitted for the product or process are established and the associated ISO-ACC
descriptor is designated, according to section 4.2.

d) Sources of chemical contamination and concentration levels that may come from:

1) outside air (new air arriving at the facility);

2) construction materials of the facility, especially those in contact with recirculation air flows
and air currents;

3) cross contamination that may occur in the facility;

4) operation and maintenance of the facility;

5) personnel, cleanroom equipment and auxiliary materials;

6) the means and tools used for the process;

Additional indications of these phenomena are given in chapters A.3 to A.8.

e) Design requirements are established in order to avoid or reduce the chemical contamination
generated according to point d) of chapter A.2, in order to obtain the ISO-ACC level for the product
or process.

A.3 Outside air

A.3.1 When outside air is supplied to the facility as fresh air to which the product or process is exposed,
the quality of the outside air should be determined, as well as any temporal variations in relation to the
concentration of components or substances that affect the product or process. Additionally, the
materials of heating, ventilation or air conditioning installations, including wiring, should be taken into
account.

A.3.2 Concentration analysis should be carried out for a period sufficient to assess its variability,
taking into account any future developments that may affect outdoor air quality.

A.3.3 In some cases, due to, for example, prevailing winds or proximity of sources of contamination,
etc., concentrations of chemical contamination can be minimised by selective positioning of the fresh
air inlet(s) to the facility.

A.3.4 The levels of outdoor air pollution present in the air entering the building may include varying
levels of pollution from exhaust from the same building or from neighboring buildings or other sources

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of pollution including farms, sewage treatment plants, landfills, highways, airports, railway stations,
local industries and other sources. These levels can vary considerably with wind direction, wind speed,
time of day, precipitation, temperature, sunlight, or other factors. It is therefore important to perform
continuous monitoring where possible of the most important parameters or to perform periodic
sampling on different dates and over many hours or many days, so that a typical average or highest
level can be assessed rather than a single data point.

Long-term average data is useful for predicting chemical filter lifespans, and real-time data can be used
to assess the highest levels found as to whether they will affect the most sensitive products.

A.4 Construction materials

A.4.1 The construction materials of the facility may be sources of chemical contamination due to the
effect of degassing.

Examples of suitable materials for cleanroom construction are given in Annex E of ISO 14644-4:2001.

A.4.2 The degree of outgassing of materials may depend on the temperature, relative humidity and
pressure in the clean room or controlled area and these effects should be specifically established based
on the design of the facility.

A.4.3 In many cases, outgassing of construction materials can occur exponentially and asymptotically
over a period of time. Finer materials (e.g. coatings) and more volatile compounds (e.g. solvents) tend
to deteriorate more rapidly, but coarser materials (flooring, insulation materials, constituent
compounds in ULPA filters) and high-boiling point compounds (plasticizers, antioxidants,
organophosphate flame retardants, high molecular weight silicones) may deteriorate much more
slowly, possibly outgassing at significant levels for many years.

A.4.4 All materials comprising a building or facility where chemical air contamination is a concern
should be evaluated for their combined chemical characteristics and selected according to their
intended use. This analysis can be presented in table form.

A.5 Cross contamination

A.5.1 Chemical contamination can occur through migration between services, partial pressure
variation transfer systems, and processes within the facility.

A.5.2 The extent of this contamination should be assessed as part of the initial design concept.

A.5.3 In some cases, cross-contamination can be minimized or prevented by isolation, closure or

separation techniques in order to confine the service or process or to protect the product or process.
Examples of these concepts are given in ISO 14644-4:2001 and Annex A of ISO 14644-7.

A.5.4 Evacuation of facilities or outdoor operations can represent a significant source of cross-
contamination. Maintaining emissions below regulatory limits, for example, may not be adequate to
protect incoming air, especially on calm days, for those processes that are sensitive to chemical air
contamination at levels much lower than regulatory limits. Similarly, some compounds that are not
regulated can still be very harmful in sensitive processes.

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UNE-EN ISO 14644-8:2023 - 16 -

A.6 Operation and maintenance

Sources of chemical contamination from the operation and maintenance of the facility can be prevented
or reduced by a program of guidelines such as those listed in ISO 14644-5, which are generally:

– ventilated/filtering face masks/helmets worn during the work process;

– qualified chemical analysis of clothing, gloves and packaging materials;

– qualified chemical analysis of liquids and other cleaning products;

– qualified chemical analysis of all product packaging materials;

– operating disciplines to minimize chemical contamination from the use of portable equipment or
temporary materials;

– temporary isolation barriers for use during maintenance or repair of machines or services;

– operating protocols to minimize chemical contamination.

For areas most sensitive to the effects of airborne chemical contamination, positive pressurization or
very careful control of air flow is required. This includes ensuring that all evacuation lines are under
negative pressure relative to the room in order to prevent chemical contamination of the air from the
most contaminated areas – which may include plenums, pits, vents, cavity walls, tunnels and ducts –
from spreading into critical areas.

A.7 Staff
Sources of chemical contamination from personnel can be prevented or minimized by rules for the
control of:

– the use of cosmetics, deodorants, hand lotions, soaps, perfumes and hair products;

– tobacco use;

– the use of medicines;

– the consumption of certain foods and drugs;

– entry and exit procedures;

– personal use of cleaning and disinfection materials.

This list is not exhaustive.

NOTE The degree of control required depends on the process itself. Pay attention to the relevant chapters of ISO 14644-5.

A.8 Other sources

These may include

– the consumables;

– the equipment;

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– the chemicals;

– the by-products of reaction, especially chemical attack or chemical vapor deposition

(CVD, Chemical Vapor Deposition);

– heaters, insulation, computers, screens, printers, electronic equipment;

– chemical leaks, refrigerants, waste streams, sewer gases, antistatic treatments.

A.9 Air treatment process to reduce chemical air pollution

Some processes are available to control or reduce the concentration of specific categories of chemical
contamination. These include:

– absorption using suitable materials (e.g. activated carbon, treated activated carbon, ion exchange
resins or zeolites);

– photoelectric ionization and electrostatic ion removal;

– catalytic photo-oxidation.

– wet scrubbers or sprayers, air showers using water and/or chemicals.

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Annex B (Informative)

Typical contaminants

Classifying suspended chemical pollutants into categories is a complex task. Many compounds have
chemical properties that fall into multiple categories, and therefore the categories of contaminants
should be a function of the harmful chemical reaction of a given specific chemical compound with the
final product manufactured in the cleanroom. Table B.1 gives typical examples of chemical contaminants
and categories that may affect a product or process. Users are encouraged to categorize chemicals or
substances that are specific to the similarly applied application.

Table B.1 is provided for guidance purposes only and is neither exhaustive nor detailed.

Table B.1 – Typical examples of chemicals and categories with a

contaminating effect and that are likely to affect a product or process
Pollutant Category
Case No. Substance Chemical formula CD
ac ba or bt cr dp ox
H M L
7664–41–7 Ammonia NH3 x x x x
141–43–5 2-Aminoethanol H2NCH2CH2OH x x xx
78–91–1 2-Aminopropanol CH3(NH2)CHCH2OH x x x
7782–50–5 Chlorine Cl2 x x x
128–37–0 BHT:di(t-butyl)hydroxytoluene CH3C6H2(t-C4H9)2OH x x x
85–68–7 Butylbenzyl phthalate H9C4OCOC6H4COOCH2C6H5 x x
7637–07–2 Boron trifluoride BF3 x xx x
1303–86–2 Boron oxide B2O3 x x
108–91–8 Cyclohexylamine C6H11NH2 x x x
— Cyclic polydimethylsiloxanes (-Si(CH3)2O-)n x x x
106–46–7 p-Dichlorobenzene ClC6H4Cl x x x
100–37–8 Diethylaminoethanol (C2H5)2NCH2CH2OH x x x
117–84–0 Dioctyl phthalate C6H4(C = OOC8H17)2 x x
84–66–2 Diethyl phthalate C6H4(C = OOC2H5)2 x x
84–74–2 Dibutyl phthalate C6H4(C = OOC4H9)2 x x
117–81–7 Di(2-ethylhexyl) phthalate C6H4(C = x x
OOCH2CHC2H5C4H9)2
84–61–7 Dichlohexyl phthalate C6H4(C = OOC6H11)2 x x
103–23–1 Di(2-ethylhexyl) adipate C4H8(C = x x
OOCH2CHC2H5C4H9)2
84–76–4 Dinonyl phthalate C6H4(C = OOC9H19)2 x x
84–77–5 Didecyl phthalate C6H4(C = OOC10H21)2 x x
541–02–6 Decamethylcyclopentasiloxane (-Si(CH3)2O-)5 x x

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Pollutant Category
Case No. Substance Chemical formula CD
ac ba or bt cr dp ox
H ML
540–97–6 Dodecamethylcyclohexanesilox (-Si(CH3)2O-)6 x x
ane
104–76–7 2-Ethylhexanol CH3(CH2)3C2H5CHCH2OH x x
75–21–8 Ethylene oxide C2H4O x x
50–00–0 Formaldehyde HCHO x x x
142–82–5 Eptane C7H16 x x
66–25–1 Hexanal C6H12O x x x
7647–01–0 Hydrochloric acid HCl x x x x
766–39–3 Hydrofluoric acid HF x x x x
10035–10–6 Hydrogen bromide HBr x x x x
7783–06–4 Hydrogen sulfide H2S x x x x
999–97–3 Hexamethyldisilacene (CH3)3SiNHSi(CH3)3 x x x
541–05–9 Hexamethylcyclotrisiloxane (-Si(CH3)2O-)3 x x
67–63–0 Isopropyl alcohol (CH3)2CHOH x x x
10102–43–9 Nitrogen monoxide NO x x x x
10102–44–0 Nitrogen dioxide NO2 x x x x
872–50–4 N-Methylpyrrolidone -(NCH3)(C = O)(CH2)3- x x x
644–31–5 Ozone O3 x x x
556–67–2 Octamethylcyclotetrasiloxane (-Si(CH3)2O-)4 x x
7803–51–2 Phosphine PH3 x x x
7446–09–5 Sulfur dioxide SO2 x x x x
75–50–3 Trimethylamine (CH3)3N x x x
121–44–8 Triethylamine (C2H5)3N x x x x
45–40–0 Triethyl phosphate (C2H5O)3P = O x x x
Tris(2-chloro-1-propyl)
6145–73–9 (CH3ClCHCH2O)3P = O x x x x
phosphate
Tris(1-chloro-2-propyl)
13674–73–9 ((CH3)(ClCH2)CH-O-)3P = O x x x x
phosphate
78–30–8 Tricresyl phosphate (CH3C6H4O)3P = O x x x
126–73–8 Tri(n-butyl) phosphate (C4H9O)3P = O x x x
Tris(222 trichloroethyl)
20405–30–5 (Cl3CH2)3P = O x x x
phosphate
115–96–8 Tris(chloroethyl) phosphate (ClC2H4O)3P = O x x x x
Tetramethylammonium
75–59–2 (CH3)4N+OH- x x x
hydroxide
95–47–6 Sileno (CH3)2C6H4 x x x
57–13–6 Urea C = O(NH2)2 x
Total phthalates R1OCOC6H4COOR2 x x
Total phosphates (RO)3P = O x x x

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Pollutant Category
Case No. Substance Chemical formula CD
ac ba or bt cr dp ox
H ML
Total, linear and cyclic
x x x x
siloxanes

Total silicone compounds,

x x x x
organic + inorganic

Total sulfur x x x x x x x
Total cyclosiloxanes (-Si(CH3)2O-)n x x
CmHnOpXy (where X is another
Total hydrocarbon derivatives x x x x
chemical element)
Total hydrocarbon derivatives CmHnOpXy, minus CH4 (where
x x x x
other than methane X is another element)
Total unsaturated hydrocarbon CmHnOpXy (where X is another
x x x x
derivatives element, with n ≤ 2m and C = O)
Legend ac: acid
ba: base
bt: biotoxic
CD: condensable
cr: corrosive
dp: doping
or: organic;
ox: oxidant.
H: very condensable, boiling point > 200 °C;
M: moderately condensable, 200 °C > Tb > 100 °C;
L: slightly condensable, 100 °C > Tb (Tb is the boiling point).

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Annex C (Informative)

Typical measurement methods

C.1 Principle
C.1.1 This annex is intended to provide guidance on the various methods of measurement and analysis
of chemical contamination, depending on the components and the assumed component concentrations.

C.1.2 The instruments cited in this annex do not constitute an exhaustive or detailed list, they are
simply examples in relation to the parameters of the current technology listed in Table C.1.

C.2 Principle of the method

C.2.1 Methods can generally be divided into two categories.

– direct analysis methods, including on-line or continuous monitoring devices;

– methods for which sampling is different and often remote from sample analysis.

C.2.2 Direct analysis instruments offer the possibility of instantaneous relative measurement.
Sampling instruments necessarily offer integrated value over sample collection time.

C.2.3 Sampling instruments can be further subdivided into passive or active sampling instruments,
using a pumping system.

C.2.4 Passive diffusion sampling (DIFF) uses a specially prepared surface allowing selective sampling
of one or more gas components. This method requires long sampling times for low ACC concentration
levels.

C.2.5 Active sampling ensures collection of contaminants by means of an air flow determined by the
use of an absorbent medium. This technique allows the collection of low concentration levels of
chemical contamination in a short period of time. Active sample collection instruments may involve the
use of complicated apparatus which must be taken into consideration for response and handling
performances.

C.2.6 Typical sampling methods may include:

– Absorbent tube (SOR), using a steel or glass tube filled with a suitable absorbent, for example, Tenax l,
activated carbon or silicon gel.

– Impregnated coated filter, with a suitable chemical reagent that ensures a specific absorption of the
contaminant.

l Tenax is an example of a suitable product available on the market. This information is provided for the convenience of
users of this document and does not constitute an endorsement by ISO of any such product.

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– Impinger (IMP) consisting of one or a series of bottles filled with deionized water or a suitable liquid
reagent.

– Sampling bag (SB) for use with high concentrations of chemical contamination that can be collected
directly by the analysis equipment. SB does not normally employ an absorption medium. For bag
sampling, the following factors must be considered for analytical accuracy: sample stability in the
sampling bag in relation to factors including diffusion of analytes into or out of the bag, absorption
onto the bag, reactions between analytes, and carry-over from previous sampling. This method is
not useful for high boiling point compounds absorbed onto polymer bags.

– Canister (CAN) or sampling bottle, using either an evacuated canister that has a valve that opens at
the location to be sampled, and therefore does not require a pump, or a bottle that is purged using
valves at both ends for different volumes, before closing it to one atmosphere or at higher pressures
in the case of compressed air lines. Sampling vessel surfaces should be appropriately passivated to
prevent loss of analytes during the usual delay time between sampling and analysis at the
concentrations of interest.

C.3 Selection of sample collection devices and typical analysis methods

C.3.1 Typical collection methods

May include, but is not limited to:

– passive diffusion sampling (DIFF);

– collector filter (FC);

– series of impingers (IMP) filled with a suitable solvent, ultrapure water, or other capture fluids that
may also contain reagents;

– sampling bags (SB) drum or container (CAN) for direct air sampling;

– absorber tubes (SOR);

– support or witness plate used as a collection collector (WW);

– droplet scanning extraction (DSE);

– diffusion tube (DT).

C.3.2 Type analysis methods

C.3.2.1 Autonomous analysis methods

These may include, but are not limited to:

– atomic absorption spectroscope (AA-S);

– atomic absorption spectroscopy-graphite furnace (AA-GF);

– atomic emission spectroscopy (AES), or more broadly, optical emission spectrometry (OES);

– vapor phase decomposition – TXRF;

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– vapor phase decomposition – ICP-MS;

– droplet displacement extraction – ICP-MS;

– mass increment detection (MGD) with resonators including quartz crystal microbalances (QCM),
surface acoustic waves (SAW) and similar devices;

– chemical phosphorescence (CL);

– capillary electrophoresis (CZE);

– gas chromatography with flame ionization detector (GC-FID);

– gas chromatography-mass spectroscopy (GC-MS);

– ion chromatography (IC);

– inductively coupled plasma mass spectroscopy (ICP-MS);

– infrared (IR) spectroscope;

– mass spectroscope (MS);

– ultraviolet radiation spectroscope (UVS);

– Fourier transform infrared spectroscopy (FTIR);

– total reflection X-ray fluorescence spectroscopy (TXRF);

– vapor phase decomposition-total reflection X-ray fluorescence (VPD-TXRF);

– time-shift secondary ion mass spectroscopy (TOF-SIMS);

– atmospheric pressure ionization mass spectroscopy (API-MS).

C.3.2.2 Connected control devices

These may include, but are not limited to:

– colorimetric detection by analysis on reactive paper (CPR);

– ion mobility spectroscopy (IMS);

– mass gain detector (accumulation of condensed organic matter) using different types of piezoelectric
resonators (MGD);

– portable gas chromatography (PGC) equipment;

– electrochemical cell (ECS) type collectors;

– ion chromatography control system (ICS);

– chemical phosphorescence control system (CLS);

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– fluoride ion monitoring device (FIM);

– surface acoustic wave (SAW);

– quartz crystal microbalance (QCM);

– optical cavity spectrometer (CRDS).

The user should be aware of the detection limits and stay within them.

Table C.1 shows a selection matrix for examples of these measurement methods.

NOTE The applicable analysis method for a given contamination concentration depends on the rate and duration of
contamination.
sampling.

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Table C.1 – Selection matrix showing examples of measurement

methods based on the expected concentration of molecules contained in the air

ISO-ACC Category of pollutants

Level N 10n Doping
g/m3 Acids Bases Organic Biotoxics Condensable Corrosives
agents
0 IMP, IC, IMP, IC, UVS, DIFF, SOR, SB, SOR, GC-FID, GC- SOR, GC-
IMP, IC, UVS,
UVS, DIFF, DIFF, ECS GC-FID, GC- MS, IR IMP, IC, UVS, FID, GC-MS,
-1 SB, DIFF, SOR,
ECS MS, IR DIFF, SOR, GC- IR, IMP, IC,
GC-FID, GC-
-2 FID, GC-MS, IR, ICP-MS, GF-
MS, IR, CPR,
ECS AAS, UVS
-3 ECS

-4 IMP, IC, IMP, IC, UVS, IMP, IC, UVS,

IMP, IC, UVS, CLS, IR, CPR, CLS, IR, CPR,
UVS, CLS,
CLS, IR, CPR, DIFF DIFF
-5 IR, CPR,
DIFF
DIFF
-6 IMP, IC, IMP, IC, UVS, SOR, GC-FID, IMP, IC, UVS, SOR, GC-FID, GC- IC, SOR, GC-
UVS, IR, IR, CLS, CPR, GC-MS, IMS IR, CLS, CPR, MS, MGD IMP, IC, UVS, MS, IMP,
CLS, CPR, DIFF IR, CLS, CPR, ICP, MS
DIFF, SOR,
-7 DIFF DIFF, SOR, GC-
GC-MS, ICP-
FID, GC-MS
MS
IMP, IC IMP, IC, IMS IMP, IC, SOR, IMP, IC, SOR,
-8 GC-MS, ICP- GC-MS
MS
IMP, IC, SOR, GC-MS SOR, GC-MS IMP, IC, CZE,
CZE, IMS IMP, IC, CZE, IMS, SOR, GC-
-9 IMS, SOR, GC- MS
MS, ICP-MS

-10 IMP, CZE IMP, IC, CZE IMP, CZE, IMP, CZE, SOR,
SOR, GC-MS, GC-MS
-11 ICP-MS,
-12
NOTE The methods corresponding to these abbreviations are listed in chapter C.3.
Annex D (Informative)

Consideration of the specific requirements to be taken

into account for separation devices

D.1 Principle
D.1.1 This annex is intended to give guidance for separation devices which, by their nature and
application, require special design features that must be taken into account in establishing level
requirements for chemical contamination of the air. Details of the different types and applications of
such devices are given in ISO 14644-7.

D.1.2 Considerations should be given to the possibility of contamination from the device itself.

In some cases, when direct ACC measurements are not possible (e.g. in too small a volume), SCC

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measurements are the only possible method of characterizing the degree of cleanliness.

NOTE The relationship between SCC (expressed as concentration per unit surface area) and ACC (expressed as concentration
per unit volume of air) is generally not known. In cases where the relationship between the measured SCC and the ACC
has been obtained experimentally (or otherwise) and is known, the SCC result can be used to calculate ACC units to
establish levels for testing and monitoring.

D.2 Particular considerations

D.2.1 The design of the separation technique used may limit selection in the sampling method and ACC
analysis. The optimum test method should be established and agreed between customer and supplier
as well as the necessary provisions regarding the design of the device with regard to the use of
connections or fixings necessary for the tests.

D.2.2 The materials used in the construction of the device should be considered in conjunction with
Annex A of this document. Many of these devices use flexible connections or barriers in conjunction
with flexible gloves, bags, or handling devices. These materials and their potential sources of chemical
contamination should be considered.

D.2.3 Modifications or additions to the materials or extensions of the device and their potential
sources of chemical contamination should be considered.

D.2.4 When the product is particularly sensitive, it may be decided to verify the performance of the
device by a process of measurement and SCC analysis of the product (see D.1.2).

When verification is performed by SCC, the period of time during which the product remains in the
device may have a major influencing factor and should be considered.

D.2.5 Pump sampling of small enclosures using a feed gas to compensate for the sampled gas can
significantly dilute the concentration of airborne chemical contaminants at the start of sampling,
especially if the sampling volume is much larger than the enclosure. This may lead to artificially low
values for the calculated concentration based on the sampling volume relative to the actual
concentration before sampling.

D.2.6 While the ACC tests in this part of ISO 14644 are for air in cleanrooms, similar principles can be
applied to other devices, enclosures and potentially to gas purged environments including clean dry air,
nitrogen, inert gases or gas mixtures. Similar concepts may also apply to pressure sampling locations,
but are not covered in this document.

D.2.7 Specific industries may have specific recommended test methods or specifications or guidelines
for the control of chemical air pollution. See Bibliography.

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Literature

[1] ISO 14644-4:2001, Cleanrooms and associated controlled environments. Part 4: Design,
construction and start-up.

[2] ISO 14644-5, Cleanrooms and associated controlled environments. Part 5: Operations.

[3] ISO 14644-7, Cleanrooms and associated controlled environments. Part 7: Separative devices (clean
air hoods, gloveboxes, isolators and mini-environments).

[4] ISO 14698 (all parts), Cleanrooms and associated controlled environments. Biocontamination
control.

[5] SEMI F21-1102, Classification of Airborne Molecular Contaminant Levels in Clean Environments.

[6] IEST-G-CC035.1, Design Considerations for AMC Filtration Systems in Cleanrooms.

[7] ASTM D5127-99, Standard Guide for Ultra Pure Water Used in the Electronics and Semiconductor
Industry.

[8] No JACA 34-:2000, Standard for Evaluation of Airborne Molecular Contaminants Emitted from
Construction/Composition Materials for Clean Room.

[9] No JACA 35A-2003, Standard for Classification of Air Cleanliness for Airborne Molecular
Contaminant (AMC) Level in Cleanrooms and Associated Controlled Environments and its
Evaluation Methods.

[10] No JACA 43-2006, Standard for Evaluation Methods on Substrate Surface Contamination in
Cleanrooms and Associated Controlled Environments.

[11] SEMI E108-0307, Test Method for the Assessment of Outgassing Organic Contamination from
Minienvironments using Gas Chromatography/Mass Spectrometry.

[12] IEST-RP-CC031.2, Method for Characterizing Outgassed Compounds from Cleanroom Materials and
Components.

[13] IDEMA Standard M11-99, General Outgas Test Procedure by Dynamic Headspace Analysis.

[14] JIS B9917-8:2010, Standard for Classification of Air Cleanliness for Airborne Molecular
Contaminants (AMC) Level in Cleanrooms and Associated Controlled Environments and its
Evaluation Methods.

[15] Fujimoto, T., Takeda, K. and Nonaka, T. 'Airborne Molecular Contamination: Contamination on
Substrates and the Environment in Semiconductors and Other Industries', in Developments in
Surface Contamination and Cleaning. William Andrew Publishing, 2008.

[16] SEMI E45-1101, Test Method for the Determination of Inorganic Contamination from
Minienvironments Using Vapor Phase Decomposition-Total Reflection X-Ray Spectroscopy (VPD-
TXRF), VPD-Atomic Absorption Spectroscopy (VPD-AAS), or VPD/Inductively Coupled Plasma- Mass

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UNE-EN ISO 14644-8:2023 - 28 -

Spectrometry (VPD/ICP-MS).

[17] SEMI E460307, Test Method for the Determination of Organic Contamination from
Minienvironments Using Ion Mobility Spectrometry (IMS).

[18] Takeda, K., Mochizuki, A., Nonaka, T., Matsumoto, I., Fujimoto, T. and Nakahara, T. Evaluation of
Outgassing Compounds from Cleanroom Construction Materials. J. IEST. 2001, 44(1), 28–32.

[19] H. Tamura, S. Fujii, K. Yuasa and N. Kagi. Evaluation Method of VOC Emissions from Cleanroom
Materials using the Double Cylinder Chamber. Journal of Architecture, Planning and
Environmental Engineering. 1999, 520, 55–59.

[20] Tamura, H., Fujii, S. and Kagi, N. Estimate of the Time Change of the Gas Emission Flux. Proceedings
of the 48th IEST Annual Technical Meeting and the 16th International Symposium on
Contamination Control, ESTECH 2002 Proceedings, pp 7-15, Anaheim, California US (2002),
BUEE 2001, Seoul, Korea (2001).

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