SIST EN ISO 14644-15:2018

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)

This document provides requirements and guidelines for assessing the chemical airborne cleanliness
of equipment and materials which are foreseen to be used in cleanrooms and associated controlled
environments which are linked to the ISO standard for cleanliness classes by chemical concentration
(see ISO 14644-8).
The following are outside the scope of this document:
— health and safety requirements;
— compatibility with cleaning agents and techniques;
— cleanability;
— biocontamination;
— specific requirements of equipment and materials for processes and products;
— design details of equipment.

Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der Reinraumtauglichkeit von Geräten und Materialien anhand der chemischen Luft- und Oberflächenkonzentration (ISO 14644-15:2017)

Diese Norm bietet Anforderungen und Anleitung für die Prüfung der luftgetragenen Reinheit von Ausrüstung und Werkstoffen, die für den Einsatz in Reinräumen und damit verbundenen kontrollierten Umgebungen vorgesehen sind, verknüpft mit der ISO-Norm für Reinheitsklassen durch chemische Konzentration (ISO 14644-8).
Gesundheits- und Sicherheitsanforderungen werden von diesem Dokument nicht abgedeckt und können durch andere rechtliche Dokumente des jeweiligen Landes abgedeckt werden.
Folgende Probleme sind ausgeschlossen:
   Vereinbarkeit mit Reinigungsmitteln und -techniken;
   Reinigungsfähigkeit;
   Biokontaminierung;
   Spezielle Anforderungen von Ausrüstung und Werkstoffen für Verfahren und Produkte;
   Design-Details der Ausrüstung.

Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de l'aptitude à l'emploi des équipements et des matériaux par la détermination de la concentration chimique aéroportée (ISO 14644-15:2017)

L'ISO 146444-15 :2017 fournit des exigences et des lignes directrices relatives à l'évaluation de la propreté chimique de l'air d'équipements et de matériaux destinés à être utilisés dans des salles propres et des environnements maîtrisés apparentés. Ces exigences et lignes directrices sont liées à la norme ISO relative aux classes de propreté chimique (voir l'ISO 14644‑8).
Les aspects suivants ne font pas partie du domaine d'application:
-      exigences de santé et de sécurité;
-      compatibilité avec les agents et les techniques de nettoyage;
-      nettoyabilité;
-      biocontamination;
-      exigences spécifiques applicables aux équipements et matériaux en ce qui concerne des procédés et des produits;
-      détails de la conception des équipements.

Čiste sobe in podobna nadzorovana okolja - 15. del: Ocena ustreznosti uporabe opreme in materialov na osnovi koncentracije onesnaževal v zraku (ISO 14644-15:2017)

Ta dokument določa zahteve in smernice za ocenjevanje čistoče
opreme in materialov na osnovi koncentracije onesnaževal v zraku za uporabo v čistih sobah in podobnih nadzorovanih
okoljih, ki so povezani s standardom ISO za razrede čistosti zraka na osnovi koncentracije onesnaževal v zraku
(glej ISO 14644-8).
Naslednje ne spada na področje uporabe tega dokumenta:
– zdravstvene in varnostne zahteve;
– združljivost s čistilnimi sredstvi in tehnikami;
– možnost čiščenja;
– biokontaminacija;
– posebne zahteve za opremo in materiale za postopke in proizvode;
– zasnovne podrobnosti opreme.

General Information

• Status: Published
• Public Enquiry End Date: 29-Jun-2016
• Publication Date: 03-Jan-2018
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Dec-2017
• Due Date: 23-Feb-2018
• Completion Date: 04-Jan-2018
• Ref Project: EN ISO 14644-15:2017 - Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-15:2018
01-februar-2018
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQDXVWUH]QRVWLXSRUDEH
RSUHPHLQPDWHULDORYQDRVQRYLNRQFHQWUDFLMHRQHVQDåHYDOY]UDNX,62

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability
for use of equipment and materials by airborne chemical concentration (ISO 14644-
15:2017)
Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der
Reinraumtauglichkeit von Geräten und Materialien anhand der chemischen Luft- und
Oberflächenkonzentration (ISO 14644-15:2017)
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de
l'aptitude à l'emploi des équipements et des matériaux par la détermination de la
concentration chimique aéroportée (ISO 14644-15:2017)
Ta slovenski standard je istoveten z: EN ISO 14644-15:2017
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-15:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-15:2018

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SIST EN ISO 14644-15:2018


EN ISO 14644-15
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2017
EUROPÄISCHE NORM
ICS 13.040.35
English Version

Cleanrooms and associated controlled environments - Part
15: Assessment of suitability for use of equipment and
materials by airborne chemical concentration (ISO 14644-
15:2017)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 15: Évaluation de l'aptitude à l'emploi des 15: Bewertung der Reinraumtauglichkeit von Geräten
équipements et des matériaux par la détermination de und Materialien anhand der chemischen Luft- und
la concentration chimique aéroportée (ISO 14644- Oberflächenkonzentration (ISO 14644-15:2017)
15:2017)
This European Standard was approved by CEN on 27 October 2017.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-15:2017 E
worldwide for CEN national Members.

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SIST EN ISO 14644-15:2018
EN ISO 14644-15:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 14644-15:2018
EN ISO 14644-15:2017 (E)
European foreword
This document (EN ISO 14644-15:2017) 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 2018 and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-15:2017 has been approved by CEN as EN ISO 14644-15:2017 without any
modification.
3

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SIST EN ISO 14644-15:2018

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SIST EN ISO 14644-15:2018
INTERNATIONAL ISO
STANDARD 14644-15
First edition
2017-10
Cleanrooms and associated controlled
environments —
Part 15:
Assessment of suitability for use of
equipment and materials by airborne
chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de l'aptitude à l'emploi des équipements et
des matériaux par la détermination de la concentration chimique
aéroportée
Reference number
ISO 14644-15:2017(E)
©
ISO 2017

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 4
5 Test setup . 5
5.1 General . 5
5.2 Closed design . 5
5.3 Closed design special application . 6
5.4 Open design . 7
6 Representative mode . 7
6.1 Equipment . 7
6.2 Material . 7
7 Visual inspection . 8
7.1 General . 8
7.2 Equipment . 8
7.3 Material . 8
8 Test description . 9
9 Calculation of the measured concentrations . 9
10 Calculation of specific emission rate .10
10.1 Calculation of specific emission rate — Closed design .10
10.2 Calculation of specific emission rate — Open design .11
11 Assessment .11
11.1 General .11
11.2 Required input data .12
11.3 Calculation to determine the effect on a cleanroom or controlled zone .12
11.4 Assessment of the suitability of material(s) or equipment for an existing
cleanroom or controlled zone .13
12 Documentation .13
12.1 General .13
12.2 Common documentation requirements .13
12.3 Test documentation .14
12.4 Visual inspection .14
12.4.1 Equipment .14
12.4.2 Materials .14
Annex A (informative) Example calculation for suitability assessment of one equipment
(existing installation) .15
Annex B (informative) Example calculation for suitability assessment of wall material
(existing cleanroom/clean zone installation) .17
Annex C (informative) Suitability assessment of a combination of equipment and floor
material in a cleanroom to be designed .19
Bibliography .21
© ISO 2017 – All rights reserved iii

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(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 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 in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all parts in the ISO 14644 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare).
This document addresses the cleanroom classification of air cleanliness by chemical concentration to
the suitability of equipment for use in cleanrooms and associated controlled environments.
Examples and suitability assessments are given in Annexes A, B and C.
© ISO 2017 – All rights reserved v

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SIST EN ISO 14644-15:2018

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SIST EN ISO 14644-15:2018
INTERNATIONAL STANDARD ISO 14644-15:2017(E)
Cleanrooms and associated controlled environments —
Part 15:
Assessment of suitability for use of equipment and
materials by airborne chemical concentration
1 Scope
This document provides requirements and guidelines for assessing the chemical airborne cleanliness
of equipment and materials which are foreseen to be used in cleanrooms and associated controlled
environments which are linked to the ISO standard for cleanliness classes by chemical concentration
(see ISO 14644-8).
The following are outside the scope of this document:
— health and safety requirements;
— compatibility with cleaning agents and techniques;
— cleanability;
— biocontamination;
— specific requirements of equipment and materials for processes and products;
— design details of equipment.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 14644-8:2013, Cleanrooms and associated controlled environments — Part 8: Classification of air
cleanliness by chemical concentration (ACC)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
air chemical contamination
any non-particulate chemical specie(s) in the air that can, by its chemical nature, adversely affect the
product, process or equipment
[SOURCE: ISO 14644-8:2013, 3.1.3, modified — “substance” has been replaced by “non-particulate
chemical specie(s)”.]
© ISO 2017 – All rights reserved 1

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

3.2
air cleanliness by chemical concentration
ACC
level of air cleanliness (3.5) 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.
[SOURCE: ISO 14644-8:2013, 3.1.2]
3.3
breakthrough volume
maximum purge gas (3.14) volume that can be drawn through a trapping system without loss of analyte
at a specific temperature
3.4
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2013, 3.1.1]
3.5
cleanliness
condition not exceeding a specified level of contamination
3.6
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.
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 may also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.7
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone (3.8) when used as
intended
Note 1 to entry: For the purposes of this document, the assessment is based on air chemical concentration.
Note 2 to entry: The definition refers to the use of equipment and materials.
[SOURCE: ISO 14644-14:2016, 3.3, modified — Note 2 has been added.]
3.8
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.
2 © ISO 2017 – All rights reserved

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(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 may also be
specified and controlled.
Note 3 to entry: A clean zone(s) may be a defined space within a cleanroom or may be achieved by a separative
device. Such a device may be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.9
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical,
biocontamination) in air and/or on surfaces is controlled and specified and which is constructed and
used in a manner to minimize the introduction and impact of contamination
Note 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or
cleanliness in terms of particle, chemical and viable concentrations on surfaces may be specified by class(es).
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e.g. temperature, humidity and
pressure, vibration and electrostatic.
Note 3 to entry: A controlled zone can be a defined space within a cleanroom or may be achieved by a separative
device. Such a device may be located inside or outside a cleanroom.
3.10
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889:2010, 3.30]
Note 1 to entry: For the purposes of this document, only chemical emission is considered.
3.11
emission rate
rate describing the mass of one or more volatile chemical(s) emitted from the equipment or material
per time unit
3.12
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE Testing and manufacturing equipment and machinery; equipment for transport and handling;
storage units; tools; furniture; doors; ceilings; IT hardware; handling robots.
[SOURCE: ISO 14644-14:2017, 3.6]
3.13
material
single substance or composite
Note 1 to entry: It might be necessary to provide material in a representative form to enable testing.
3.14
purge gas
gas or gas mixture to carry contaminant to a defined outlet
Note 1 to entry: In a controlled or clean zone (3.8) or a cleanroom (3.6), filtered air might be used as purge gas.
Note 2 to entry: A test environment (3.18) might be purged with air or other gases or gas mixtures to carry the
contaminant to a trapping system or measurement device.
© ISO 2017 – All rights reserved 3

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

3.15
representative form
material sample produced to represent the intrinsic physical and chemical properties of an object
3.16
representative mode
mode of operation that reflects the intended use of the equipment
3.17
specific emission rate
normalized mass flow of chemical contaminants emitted from a test object
Note 1 to entry: Material-specific emission rate (3.11) is based on surface area.
Note 2 to entry: Equipment-specific emission rate is based on one single unit of equipment.
3.18
test environment
space in which the test is carried out, described by a set of parameters
[SOURCE: ISO 14644-14:2017, 3.7]
4 Symbols
Symbol Meaning Unit
3
p Background concentration in the test environment without the g/m
b
test object
3
p Concentration in the test environment with the test object g/m
o
3
p Chemical mass concentration in the cleanroom/controlled zone g/m
c
3
p Chemical mass concentration of the make up air g/m
m
3
F Sampling flow rate background measurement m /s
b
3
F Sampling flow rate object measurement m /s
o
m Total sampled mass emitted from the test environment with g
o
test object
m Total sampled mass emitted from the test environment without g
b
test object
t Sampling duration object measurement s
o
t Sampling duration background measurement s
b
2
x Specific metric related to the test object m for materials
“unit” for equipment
2
x Quantity related to the assessed object m for materials
“unit” for equipment
2
q Specific emission rate of the test object g/(m s) or g/(unit · s)
o
n Air change rate through the test environment 1/s
t
n Make up air change rate 1/s
m
n Recirculated air change rate 1/s
r
3
V Volume of air in the cleanroom/ controlled zone m
c
3
V Volume of the test environment m
t
α Specified efficiency of the chemical filtration system —
4 © ISO 2017 – All rights reserved

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

5 Test setup
5.1 General
The test setup shall be designed for collecting representative samples of contaminants within the test
environment in order to assess specific emission rates from equipment and/or materials. It can be
designed as closed (see Figure 1), closed special application (see Figure 2) or open (see Figure 3).
Closed design is used for low specific emission rates and is the preferred method. Larger test objects
and equipment in operation may require the use of an open design test setup (see 5.4).
The tolerance of the temperature sensor shall be ±2 °C.
The tolerance of the flow meter shall be ±5 %.
The humidity of the purge gas shall be specified and controlled.
The sampling of ACC-emissions is performed by purging a defined gas volume onto a suitable
trapping system, e.g. an adsorber. Multiple trapping systems can be used to collect different species of
contaminants.
ISO 14644-8:2013, Annex C gives an overview regarding trapping and measuring techniques.
NOTE For considerations regarding VOC-sampling, see ISO 16000-6 and ISO 16017-1.
5.2 Closed design
Key
1 purge gas source 7 trapping system(s)
2 valve for purge gas supply 8 flow meter(s)
3 connection to chamber 9 valve(s) for flow control
4 test chamber 10 pump (option)
5 temperature sensor 11 mixing device (option)
6 material sample or equipment
NOTE Depending on the size of the test environment, a mixing device can be installed to enable
homogeneous mixing.
Figure 1 — Closed design
Using a closed design requires a flow-controlled purge gas supply and a flow meter installed after the
trapping system. The purge gas flow shall be controlled by a valve. In addition, a pump may be used
downstream of the flow meter.
© ISO 2017 – All rights reserved 5

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SIST EN ISO 14644-15:2018
ISO 14644-15:2017(E)

5.3 Closed design special application
Key
1 purge gas source 7 trapping system(s)
2 valve for purge gas supply 8 flow meter(s)
3 connection to chamber 9 valve(s) for flow control
4 test chamber 10 pump (option)
5 temperature sensor 11 mixing device (option)
6 material sample
Figure 2 — Closed design special application
This setup is used for material samples with even surfaces. Both the enclosure and the material sample
surface shall form a gastight test environment.
To obtain a background analysis, substitute test material with glass or stainless steel pla
...

SLOVENSKI STANDARD
oSIST prEN ISO 14644-15:2016
01-junij-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQDXVWUH]QRVWLXSRUDEH
RSUHPHLQPDWHULDORYQDRVQRYLNRQFHQWUDFLMHRQHVQDåHYDOY]UDNX,62',6

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability
for use of equipment and materials by airborne chemical concentration (ISO/DIS 14644-
15:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der
Reinraumtauglichkeit von Geräten und Materialien anhand der chemischen Luft- und
Oberflächenkonzentration (ISO/DIS 14644-15:2016)
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de
l'aptitude à l'emploi des équipements et des matériaux par la détermination de la
concentration chimique aéroportée (ISO/DIS 14644-15:2016)
Ta slovenski standard je istoveten z: prEN ISO 14644-15
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-15:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 14644-15:2016

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oSIST prEN ISO 14644-15:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-15
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-04-07 2016-07-06
Cleanrooms and associated controlled environments —
Part 15:
Assessment of suitability for use of equipment and
materials by airborne chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de la compatibilité des équipements à l’emploi en salle propre en termes de propreté
chimique de l’air et des surfaces
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 three month enquiry.
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.
To expedite distribution, this document is circulated as received from the
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Contents Page
Foreword .v
Introduction .vi
1 Scope.1
2 Normative references .1
3 Terms and definitions.1
4 Symbols and abbreviations .4
5 Test setup .5
5.1 General .5
5.2 Closed design .5
5.3 Closed design special application .6
5.4 Open design .7
6 Representative mode.7
6.1 Equipment .7
6.2 Material .7
7 Visual inspection .8
7.1 General .8
7.2 Equipment .8
7.3 Material .8
8 Test Description.8
9 Calculation of the measured concentrations .9
10 Calculation of specific emission rate . 10
10.1 Calculation of specific emission rate – closed design. 10
10.2 Calculation of specific emission rate – open design . 10
11 Assessment. 11
11.1 General . 11
11.2 Required input data . 11
11.3 Calculation to determine the effect on a controlled zone or cleanroom . 12
11.4 Assessment of the suitability of material(s) or equipment for an existing cleanroom/
controlled zone . 12
12 Documentation . 13
12.1 General . 13
12.2 Common documentation requirements. 13
12.3 Test documentation . 13
12.4 Visual inspection . 14
12.4.1 Equipment . 14
12.4.2 Materials. 14
Annex A (informative) Example calculation for suitability assessment of one equipment (existing
installation). 15
Annex B (informative) Example calculation for suitability assessment of wall material (existing
cleanroom/clean zone installation) . 17
Annex C (informative) Suitability assessment of a combination of equipment and floor material
in a cleanroom to be designed . 19
Bibliography . 21
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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 14644-15 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, and by Technical Committee CEN/TC 243, Cleanroom technology in collaboration.
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
 Part 12: Classification of air cleanliness by nanoscale particle concentration
 Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical
classifications
 Part 14: Assessment of suitability for use of equipment by airborne particle concentration
 Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration
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Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-
contamination control:
 Part 1: General principles and methods
 Part 2: Evaluation and interpretation of biocontamination data
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the
control of contamination include those in such industries as aerospace, microelectronics, optics, nuclear, and
life sciences (pharmaceuticals, medical devices, food, healthcare).
This document addresses the cleanroom classification of air cleanliness by chemical concentration to the
suitability of equipment for use in cleanrooms and associated controlled environments.
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1 Scope
This standard provides requirements and guidance for assessing the chemical airborne cleanliness of
equipment and materials which are foreseen to be used in cleanrooms and associated controlled
environments which are linked to the ISO standard for cleanliness classes by chemical concentration
(ISO 14644-8).
Health and safety requirements are not covered by this document and may be covered by legal documents of
the specific country.
The following issues are excluded:
 compatibility with cleaning agents and techniques;
 cleanability;
 biocontamination;
 specific requirements of equipment and materials for processes and products;
 design details of equipment.
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 14644-8:2013, Cleanroom and associated controlled environments — Part 8: Classification of air
cleanliness by chemical concentration.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
air chemical contamination
any substance in the air that can, by its chemical nature, adversely affect the product, process or equipment
[ISO 14644-8:2013]
3.2
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 meter
Note 1 to entry: This definition does not include macromolecules of biological origin, w hich are judged to be particles.
[SOURCE: ISO 14644-8:2013, 3.1.2]
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3.3
breakthrough volume
maximum purge gas volume that can be drawn through an adsorber without loss of analyte at a specific
temperature
3.4
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2013, 3.1.1]
3.5
Cleanliness
Condition not exceeding a specified level of contamination
3.6
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.
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.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.7
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone when used as intended
Note 1 to entry: For the purposes of this standard, the assessment is based on airborne particle concentration.
[SOURCE: ISO/FDIS 14644-14:2015, 3.3]
3.8
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 conc entrations might also be specified
and controlled.
Note 3 to entry: A clean zone(s) can be a defined space w ithin 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.
[SOURCE: ISO 14644-1:2015, 3.1.2]
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3.9
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical-,
biocontamination) in air and/or on surfaces is controlled and specified and which is constructed and used in a
manner to minimize the introduction and impact of contamination
Note 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or cleanliness in
terms of particle, chemical and viable concentrations on surfaces should be specified by class(es).
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e. g. temperature, humidity and
pressure, vibration and electrostatic.
Note 3 to entry: A controlled zone can be a defined space w ithin a cleanroom or may be achieved by a separate
device. Such a device can be located inside or outside a cleanroom.
3.10
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889:2010, 3.30]
Note 1 to entry: For the purposes of this standard only chemical emission is considered.
3.11
emission rate
rate describing the mass of one or more volatile chemical(s) emitted from equipment or material per time unit
3.12
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE testing and manufacturing equipment and machinery; equipment for transport and handling; storage
units; tools; furniture; doors; ceilings; IT hardw are; handling robots
[SOURCE: ISO/FDIS 14644-14:2015, 3.6]
3.13
material
single substance or composite
Note 1 to entry: It may be necessary to provide material in a representative form to enable testing.
3.14
purge gas
gas or gas mixture to carry contaminant to a defined outlet
Note 1 to entry: In a controlled or clean zone or a cleanroom, filtered air can be used as purge gas.
Note 2 to entry: A test environment may be purged w ith air or other gases or gas mixtures to carry the contaminant to
an adsorber or measurement device.
3.15
representative form
material sample produced to represent the intrinsic physical and chemical properties of an object
3.16
representative mode
mode of operation that reflects the intended use of the equipment
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3.17
specific emission rate
normalized mass flow of chemical contaminants emitted from a test object
Note 1 to entry: Material specific emission rate is based on surface area.
Note 2 to entry: Equipment specific emission rate is based on one single unit of equipment.
3.18
test environment
space in which the test is carried out, described by a set of parameters
[SOURCE: ISO/FDIS 14644-14:2015, 3.7]
4 Symbols and abbreviations
The following symbols and abbreviations are used in this part of ISO 14644:
Symbol Meaning Unit
p g/m³
b background concentration in the test environment without the test
object
po concentration in the test environment with the test object g/m³
3
p Chemical mass concentration in the cleanroom/controlled zone g/m
c
3
pm chemical mass concentration of the make-up air g/m
F Sampling flow rate background measurement ?
b
F Sampling flow rate object measurement ?
o
m g
o total sampled mass emitted from the test environment with test
object
m g
b total sampled mass emitted from the test environment without
test object
t sampling duration object measurement s
o
t sampling duration background measurment s
b
2
x Specific metric related to the test object m for materials

“unit” for equipment
2
x Quantity related to the assessed object m for materials
“unit” for equipment
2
q Specific emission rate of the test object g/(m s) or g/(s·unit)
o
nt Air change rate through the test environment 1/s
n Make-up air change rate 1/s
m
n recirculated air change rate 1/s
r
3
V Volume of air in the cleanroom/ controlled zone m
c
3
V Volume of the test environment m
t
α efficiency of the chemical filtration system -

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5 Test setup
5.1 General
The test setup shall be designed for collecting representative samples of contaminants within the test
environment in order to assess specific emission rates from equipment and/or materials. It can be designed as
closed (see Figure 1), closed special application (see Figure 2) or open (see Figure 3).
Closed design is used for low specific emission rates and is the preferred method. Larger test objects and
equipment in operation may require the use of an open design test setup (see 5.4).
The tolerance of the temperature sensor shall be ± 2 °C.
The tolerance of the flow meter shall be ± 5 %
The sampling of ACC-emissions is performed by purging a defined gas volume onto a suitable trapping
adsorbent. Multiple adsorber systems can be used to collect different species of contaminants.
ISO 14644-8:2013, Annex C gives an overview regarding trapping and measuring techniques.
NOTE For considerations regarding VOC-sampling see ISO 16000-6 and ISO 16017-1.
5.2 Closed design

NOTE Depending on the size of the test environment, a mixing device may be installed to enable homogeneous
mixing.
Key
1 purge gas source   6 material sample or equipment 11 mixing device (option)
2 valve for purge gas supply  7 adsorber(s)
3 connection to chamber  8 flow meter(s)
4 test chamber   9 valve(s) for flow control
5 temperature sensor  10 pump (option)
Figure 1 — Closed design
Using a closed design requires a flow controlled purge gas supply and a flow meter installed after the
adsorber. The purge gas flow shall be controlled by a valve. In addition a pump may be used downstream of
the flow meter.
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5.3 Closed design special application

1 purge gas source   6 material sample 11 mixing device (option)
2 valve for purge gas supply  7 adsorber(s)
3 connection to chamber  8 flow meter(s)
4 test chamber   9 valve(s) for flow control
5 temperature sensor  10 pump (option)
Figure 2 — Closed design special application
This setup is used for material samples with even surfaces. Both, the enclosure and the material sample
surface, shall form a gastight test environment.
NOTE To obtain a background analysis substitute test material w ith glass or stainless steel plate that can be
chemically cleaned to the same extent as the chamber w alls.
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5.4 Open design

Key
1 make up air      7 adsorber(s)
2 exhaust air      8 flow meter(s)
3 optional air recirculation (without chemical filtration) 9 valve(s) for flow control
4 test chamber      10 pump (option)
5 temperature sensor     11 mixing device (option)
6 material sample or equipment
Figure 3 — Open design
This setup is intended for larger equipment and equipment in operation. It typically represents a cleanroom or
controlled zone; therefore air is used as purge gas. Chemical filtration, make up air and background emission
can influence the capability of this test setup. The sampled amount of gas is a defined portion of the purge gas
going through the test environment. The remaining excess purge gas is released by the exhaust air (leakage
of the test environment and exhaust air passing the HVAC-system)
6 Representative mode
6.1 Equipment
The representative mode of operation has to reflect the intended use of the equipment. Representative
equipment parameters of operation shall be defined and agreed before testing.
6.2 Material
Materials shall be assessed in a form directly related to its intended use (including the material characteristics
as layers, composite, thickness, porosity and surface texture) by considering following parameters:
 Age of material: 28±2 days;
 Physical state: solid or liquid;
 Surface area of the sample, derived from measurement or from projection (for porous and granular
materials).
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If such a material sample cannot be obtained the proxy sample shall be manufactured with the same chemical
composition and shall have undergone a similar forming process as the finished component.
Material of different age can be assessed, but this deviation shall be clearly high-lighted. A comparison of
materials can only be performed based on using the same material age.
7 Visual inspection
7.1 General
Visual surface cleanliness shall be qualitatively assessed, before and after any quantitative assessment, such
that the quantitative tests shall not be compromised. The visual inspection should focus on chemical sources
that may have been inadvertently introduced during manufacture, packaging, shipment or in the case of
equipment, installation.
The results from visual inspection should be documented and be available for comparison with any post -test
visual inspection results. The outcome of a visual inspection may be used as basis to direct a repeat or
improved decontamination process for equipment, or the submission of a replacement material sample.
It is not intended that this inspection provides a measurement of sample cleanliness.
7.2 Equipment
The visual inspection shall ensure that all packaging has been removed, the equipment is undamaged, is
correctly assembled and appropriately connected to its required utilities.
Inspection should identify contamination, such as particles and films that may have originated from
manufacturing, packaging, transportation or initial assembly, which has withstood any prior decontamination
process.
Detection efficiency of visible contamination for equipment will depend upon the following factors:
 The accessibility and orientation of the surface to be inspected;
 Materials used for equipment construction, their surface condition and treatment;
 Viewing parameters (e. g. illumination type, field of view, vision magnification, viewing distance).
7.3 Material
This visual inspection should focus on chemical sources that may have been inadvertently introduced during
manufacture, shipment, re-sizing or other preparation actions undergone by the material.
Therefore the objectives of this inspection are to:
 Identify visual characteristics of the material that could influence subsequent testing. These
characteristics could include sample homogeneity, surface roughness, texture and porosity. Following
quantifiable testing the inspection should assess samples for any degradation due to test environment
factors such as temperature.
 Visual inspection parameters such as viewing distance and illumination type can be more consistent than
those for equipment due to smaller sample size. Again, inspection parameters, along with the results of
inspection shall be documented.
8 Test Description
The following outline describes the necessary sampling and analysis steps.
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1) Select test environment with regards to sample size, the geometry and mode of operation
2) Select suitable adsorber (type and capacity), purge gas and analysi
...