SIST EN ISO 14644-13:2017

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)

This part of ISO 14644 addresses the cleaning (removal of contaminants) to a specified degree on cleanroom surfaces, surfaces of equipment in the cleanroom and surfaces of materials in the cleanroom.
The following are excluded from this document:
• product and process cleaning;
• cleaning of microbiological contamination;
• detailed cleaning methods and procedures.
This part of ISO 14644 provides guidance about different cleaning techniques, classified, e.g. as wet/dry and physical/chemical.
This part of ISO 14644 provides guidance on which methods should be used for achieving required Surface cleanliness by particle concentration (SCP) and Surface cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve these specified levels.
The efficacy of cleaning techniques makes reference to the cleanliness classes and associated test methods found in ISO 14644-8, -9 and -10.
The following matters of general guidance are provided:
• assessment of adverse effects such as health and safety considerations,
surface/material properties;
• compatability of surfaces with the cleaning technique,
• surface attributes such as morphology;
• configurations such as crevices, holes and cracks,
• waste and effluent
• suitability of cleaning agents and materials (e.g. purity, cleanliness, properties)

Reinräume und zugehörige Reinraumbereiche - Teil 13: Reinigung von Oberflächen zur Erreichung definierter Reinheitsgrade hinsichtlich Partikel- und Chemikalienklassifikationen (ISO 14644-13:2017)

Die Norm behandelt die Reinigung von Reinraumoberflächen, Oberflächen der Ausrüstung in einem Rein-raum und Oberflächen von Materialien in einem Reinraum bis zu einem festgelegten Grad. Sie gibt Anleitungen zur Bewertung von Reinigungsverfahren zum Erreichen der geforderten Klassen der partiku-lären Oberflächenreinheit (SCP, en: surface cleanliness by particle concentration) und der chemischen Oberflächenreinheit (SCC, en: surface cleanliness by chemical concentration) und in Bezug darauf, welche Techniken zum Erreichen dieser festgelegten Grade berücksichtigt werden sollten.
Die Wirksamkeit von Reinigungstechniken wird auf die Reinheitsklassen und die damit verbundenen Prüfverfahren aus ISO 14644 9:2012 und ISO 14644 10:2013 verweisen.
Die folgenden Aspekte der allgemeinen Anleitung werden vorausgesetzt:
   die erwarteten Oberflächenreinheitsgrade;
   die Eignung der Reinigungsverfahren;
   die Kompatibilität von Oberflächen mit der Reinigungstechnik;
   die Bewertung der Reinigungswirksamkeit.
Das Folgende wird in dieser Norm nicht berücksichtigt:
   die Klassifizierung von Reinigungsverfahren;
   das innerhalb eines Reinraum hergestellte Produkt;
   die spezifische Oberfläche in Bezug auf die Reinigungsverfahren;
   die detaillierte Beschreibung von Reinigungsmechanismen, -verfahren sowie Verfahrensweisen von verschiedenen Reinigungsverfahren;
   die detaillierten Materialkenngrößen;
   die Beschreibung von Mechanismen hinsichtlich von Schäden durch die Reinigungsprozesse und zeitabhängige Auswirkungen;
   Verweisungen auf interaktive Bindungskräfte zwischen den Kontaminanten und Oberflächen oder Generierungsprozesse, die üblicherweise zeit- und prozessabhängig sind;
   weitere Kenngrößen von Partikeln, beispielsweise elektrostatische Ladung, Ionenladungen usw.;
   die chemischen Reaktionen zwischen molekularen Kontaminanten und Oberflächen;
   die mikrobiologischen Aspekte der Oberflächenreinheit;
   die radioaktiven Aspekte der Kontamination;
   die Aspekte des Gesundheitsschutzes und der Arbeitssicherheit;
   die Umweltaspekte, beispielsweise Abfallentsorgung, Emissionen usw.;
   die Auswahl und Anwendung von statistischen Verfahren.

Salles propres et environnements maîtrisés apparentés - Partie 13: Nettoyage des surfaces afin d'obtenir des niveaux de propreté par rapport aux classifications particulaire et chimique (ISO 14644-13:2017)

ISO 14644-13:2017 donne des lignes directrices concernant le nettoyage, jusqu'à atteindre un degré de nettoyage spécifié, des surfaces d'une salle propre ainsi que des surfaces des équipements et des matériaux contenus dans une salle propre. Toutes les surfaces d'intérêt (internes ou externes) sont concernées par le présent document. Il fournit des préconisations concernant l'évaluation des méthodes de nettoyage en vue d'obtenir les classes exigées de propreté particulaire des surfaces (SCP) et de propreté chimique des surfaces (SCC) ainsi que les techniques qu'il convient d'utiliser pour atteindre ces niveaux spécifiés.
L'adéquation des techniques de nettoyage fera référence aux classes de propreté et aux méthodes d'essai associées disponibles dans l'ISO 14644‑9 et l'ISO 14644‑10.
Les préconisations générales porteront sur les questions suivantes:
-      niveaux de propreté des surfaces souhaités;
-      pertinence des méthodes de nettoyage;
-      compatibilité des surfaces avec la technique de nettoyage;
-      évaluation de l'adéquation du nettoyage.
Les points suivants ne seront pas traités dans le présent document:
-      classification des méthodes de nettoyage;
-      produits fabriqués dans une salle propre;
-      méthodes de nettoyage spécifiques en lien avec une surface;
-      description détaillée des mécanismes de nettoyage, méthodes et modes opératoires de diverses méthodes de nettoyage;
-      caractéristiques détaillées des matériaux;
-      description des mécanismes de détérioration dus aux procédés de nettoyage et effets dans le temps;
-      références aux forces de liaison entre les contaminants et les surfaces, ou aux processus de génération qui dépendent généralement du temps et du procédé;
-      autres caractéristiques des particules, telles que la charge électrostatique, les charges ioniques, etc.;
-      réactions chimiques entre les contaminants moléculaires et les surfaces;
-      aspects microbiologiques de la propreté des surfaces;
-      aspects radioactifs de la contamination;
-      considérations relatives à la santé et la sécurité;
-      aspects environnementaux tels que l'élimination des déchets, les émissions, etc.;
-      sélection et utilisation de méthodes statistiques.

Čiste sobe in podobna nadzorovana okolja - 13. del: Čiščenje površin za doseganje določenih ravni čistoče po klasifikaciji delcev in kemikalij (ISO 14644-13:2017)

Ta del standarda ISO 14644 obravnava čiščenje (odstranjevanje kontaminantov) v določeni meri na površinah čistih prostorov, površinah opreme v čistih prostorih in površinah materialov v čistih prostorih.
Iz tega dokumenta so izključeni:
• čiščenje izdelkov in postopkov;
• čiščenje mikrobiološke kontaminacije;
• podrobne metode in postopki čiščenja.
V tem delu standarda ISO 14644 so podane smernice o različnih metodah čiščenja, ki so razvrščene, npr. mokro/suho in fizično/kemično.
V tem delu standarda ISO 14644 so podane smernice o metodah, ki naj bi se jih uporabilo za doseganje zahtevane čistosti površine s koncentracijo delcev (SCP) in čistočo površine s kemičnimi koncentracijami (SCC) in katere tehnike naj bi se upoštevalo, da te ravni dosežejo.
Učinkovitost tehnik čiščenja se nanaša na razrede čistoče in s tem povezane preskusne metode, ki jih najdemo v standardu ISO 14644-8, -9 in -10.
Zagotavlja naslednje splošne smernice:
• oceno škodljivih učinkov, kot so zdravstveni in varnostni vidiki,
lastnosti površine/materiala;
• združljivost površin s čistilno tehniko,
• površinske lastnosti, kot je morfologija;
• konfiguracije, kot so špranje, luknje in razpoke,
• odpadki in odplake
• primernost čistilnih sredstev in materialov (npr. čistost, snažnost, lastnosti)

General Information

• Status: Published
• Public Enquiry End Date: 09-May-2016
• Publication Date: 22-Aug-2017
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 17-Aug-2017
• Due Date: 22-Oct-2017
• Completion Date: 23-Aug-2017
• Ref Project: EN ISO 14644-13:2017 - Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications (ISO 14644-13:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-13:2017
01-oktober-2017
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHOýLãþHQMHSRYUãLQ]D
GRVHJDQMHGRORþHQLKUDYQLþLVWRþHSRNODVLILNDFLMLGHOFHYLQNHPLNDOLM,62

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to
achieve defined levels of cleanliness in terms of particle and chemical classifications
(ISO 14644-13:2017)
Reinräume und zugehörige Reinraumbereiche - Teil 13: Reinigung von Oberflächen zur
Erreichung definierter Reinheitsgrade hinsichtlich Partikel- und
Chemikalienklassifikationen (ISO 14644-13:2017)
Salles propres et environnements maîtrisés apparentés - Partie 13: Nettoyage des
surfaces afin d'obtenir des niveaux de propreté par rapport aux classifications
particulaire et chimique (ISO 14644-13:2017)
Ta slovenski standard je istoveten z: EN ISO 14644-13:2017
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
SIST EN ISO 14644-13:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-13:2017

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SIST EN ISO 14644-13:2017


EN ISO 14644-13
EUROPEAN STANDARD

NORME EUROPÉENNE

August 2017
EUROPÄISCHE NORM
ICS 13.040.35
English Version

Cleanrooms and associated controlled environments - Part
13: Cleaning of surfaces to achieve defined levels of
cleanliness in terms of particle and chemical classifications
(ISO 14644-13:2017)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 13: Nettoyage des surfaces afin d'obtenir des 13: Reinigung von Oberflächen zur Erreichung
niveaux de propreté par rapport aux classifications definierter Reinheitsgrade hinsichtlich Partikel- und
particulaire et chimique (ISO 14644-13:2017) Chemikalienklassifikationen (ISO 14644-13:2017)
This European Standard was approved by CEN on 26 May 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-13:2017 E
worldwide for CEN national Members.

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SIST EN ISO 14644-13:2017
EN ISO 14644-13:2017 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 14644-13:2017
EN ISO 14644-13:2017 (E)
European foreword
This document (EN ISO 14644-13:2017) 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 February 2018 and conflicting national standards shall
be withdrawn at the latest by February 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 14644-13:2017 has been approved by CEN as EN ISO 14644-13:2017 without any
modification.
3

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SIST EN ISO 14644-13:2017
INTERNATIONAL ISO
STANDARD 14644-13
First edition
2017-06
Cleanrooms and associated controlled
environments —
Part 13:
Cleaning of surfaces to achieve defined
levels of cleanliness in terms of
particle and chemical classifications
Salles propres et environnements maîtrisés apparentés —
Partie 13: Nettoyage des surfaces afin d’obtenir des niveaux de
propreté par rapport aux classifications particulaire et chimique
Reference number
ISO 14644-13:2017(E)
©
ISO 2017

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ISO 14644-13:2017(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 14644-13:2017
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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General methodology . 3
4.1 Overview . 3
4.2 Methodology . 4
5 Object description . 6
6 Cleanliness specifications . 7
7 Determination of initial contamination level . 7
7.1 General . 7
7.2 Determination of initial contamination level with respect to particle concentration . 7
7.3 Determination of initial contamination level with respect to chemical concentration. 7
8 Other requirements . 8
9 Selection of a cleaning methodology . 8
9.1 Selection procedure . 8
9.2 Cleaning methodologies . 8
9.2.1 Cleaning method . 8
9.2.2 Categories of cleaning techniques . 8
9.3 Cleaning process . 9
10 Material compatibility check . 9
11 Cleaning validation .10
11.1 General .10
11.2 Cleaning efficiency .11
11.2.1 Evaluation .11
11.2.2 Cleaning efficiency with respect to particle concentration .11
11.2.3 Cleaning efficiency with respect to chemical contamination .12
11.3 Cleaning appropriateness .13
11.3.1 Assessment .13
11.3.2 Cleaning appropriateness with respect to particle concentration .13
11.3.3 Cleaning appropriateness with respect to chemical concentration .14
12 Measurement methods .15
12.1 General .15
12.2 Direct measurement methods .15
12.2.1 General.15
12.2.2 Direct measurement methods with respect to SCP .16
12.2.3 Direct measurement methods with respect to SCC .16
12.3 Indirect measurement methods .16
12.3.1 General.16
12.3.2 Indirect measurement methods with respect to SCP .16
12.3.3 Indirect measurement methods with respect to SCC .17
13 Documentation .17
Annex A (informative) Aspects of cleaning .18
Annex B (informative) Cleaning methods .19
Annex C (informative) Material compatibility with cleaning agents .27
Annex D (informative) Cleanliness measurement .29
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Bibliography .34
iv © ISO 2017 – All rights reserved

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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.
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: w w w . i s o .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.
© ISO 2017 – All rights reserved v

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Introduction
The term surface refers to the interface between two phases. For the purpose of this document, the
surface is a solid. A “clean surface” is where one or more of the contamination categories (particles,
chemical) are under control due to cleaning/decontamination. The degree of cleanliness is specified
in the corresponding surface cleanliness classifications (see ISO 14644-9 and ISO 14644-10). Different
cleaning methods are necessary depending on the degree of cleanliness (cleanliness class) required.
This document gives guidance on the selection of cleaning methods to achieve specified cleanliness
levels. For the selection procedure, the aspects of surface description, cleanliness specifications, types
of contamination, cleaning techniques, material compatibility, and assessment methodology are taken
into consideration. Most of the methods are suitable for removal of more than one contamination
category at the same time; therefore, a common standard for the selection of a cleaning method for both
particles, as well as chemical contamination, is needed.
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SIST EN ISO 14644-13:2017
INTERNATIONAL STANDARD ISO 14644-13:2017(E)
Cleanrooms and associated controlled environments —
Part 13:
Cleaning of surfaces to achieve defined levels of cleanliness
in terms of particle and chemical classifications
1 Scope
This document gives guidelines for cleaning to a specified degree on cleanroom surfaces, surfaces of
equipment in a cleanroom and surfaces of materials in a cleanroom. Under consideration are all surfaces
(external or internal) that are of interest. It provides guidance on the assessment of cleaning methods
for achieving the required surface cleanliness by particle concentration (SCP) and surface cleanliness
by chemical concentration (SCC) classes and which techniques should be considered to achieve these
specified levels.
The appropriateness of cleaning techniques will make reference to the cleanliness classes and
associated test methods found in ISO 14644-9 and ISO 14644-10.
The following matters of general guidance will be provided:
— expected surface cleanliness levels;
— suitability of cleaning methods;
— compatibility of surfaces with the cleaning technique;
— assessment of cleaning appropriateness.
The following will be excluded from this document:
— classification of cleaning methods;
— product produced within a cleanroom;
— specific surface-related cleaning methods;
— detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
— detailed material characteristics;
— description of damage mechanisms by cleaning processes and time-dependent effects;
— references to interactive bonding forces between contaminants and surfaces or generation processes
that are usually time-dependent and process-dependent;
— other characteristics of particles such as electrostatic charge, ionic charges, etc.;
— chemical reactions between molecular contaminants and surfaces;
— microbiological aspects of surface cleanliness;
— radioactive aspects of contamination;
— health and safety considerations;
— environmental aspects such as waste disposal, emissions, etc.;
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— selection and use of statistical methods.
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, Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness
by chemical concentration (ACC)
ISO 14644-9, Cleanrooms and associated controlled environments — Part 9: Classification of surface
cleanliness by particle concentration
ISO 14644-10, Cleanrooms and associated controlled environments — Part 10: Classification of surface
cleanliness by chemical concentration
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14644-9, ISO 14644-10 and
the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
cleanliness
condition of a solid surface where the amount of contamination (3.4) (particle,
chemical) is controlled to a specific level
3.2
cleaning appropriateness
relation between the required cleanliness (3.1) and the accomplished cleanliness under controlled
conditions
Note 1 to entry: In some languages, the term cleaning efficacy is used to indicate cleaning appropriateness.
Note 2 to entry: In case of real operational conditions or monitoring, the term cleaning effectiveness is used.
3.3
cleaning efficiency
fraction of specific contaminants removed from a surface by a cleaning process
Note 1 to entry: The fraction is determined by the accomplished surface cleanliness in respect to the initial
surface cleanliness.
3.4
contamination
unwanted matter in an undesirable location
3.5
particle
minute piece of matter with defined physical boundaries
[SOURCE: ISO 14644-1:2015, 3.2.1]
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3.6
particle contamination
particles (3.5) having the potential to affect the process, the product, the personnel or the facilities
3.7
particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent
to the response produced by the particle (3.5) being measured
4 General methodology
4.1 Overview
Multiple aspects need to be considered for cleaning. Figure 1 provides an overview of the factors that
contribute to the suitability of cleaning methods to achieve a defined level of surface cleanliness. For
more details, see Annex A.
Key
+ more details in Figure A.1
Figure 1 — Overview of cleaning aspects (non-exhaustive)
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4.2 Methodology
Appropriateness of a cleaning technique for an application depends on many factors. For complex
objects, it is advised to follow the sequence described in this clause and in the decision tree (see
Figure 2). By using this procedure, it can be assured that all important issues are covered. For simple
objects or surfaces, deviations from the sequence are allowable, as long as the critical information is
documented.
The approach starts with describing the object that has to be cleaned. The description should cover,
among others, composition of materials, chemical characteristics, surface finish and shape factors like
geometrical complexity and size (step 1). In the second step, the objective of the cleaning procedure
is to be specified in terms of the desired cleanliness of the object. To have a starting point, the initial
contamination level should be assessed (step 3) and other requirements shall be listed (step 4). Based
on type of contaminants and the required removal efficiency, a cleaning technique or a combination of
techniques can be selected (step 5). The cleaning methodology shall be checked against the materials
from the first step in order to avoid material compatibility issues (step 6). At the last step, a validation
method shall be carried out (step 7). The validation shall at least comprise methods for determination of
the cleaning performance and material compatibility. The performance of the cleaning shall be checked
against the specification.
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Figure 2 — Decision tree
© ISO 2017 – All rights reserved 5

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5 Object description
In the object description, the following aspects shall be considered.
Physical properties of the object:
— physical dimensions;
— form/shape/complexity of the object;
— critical surfaces.
A general description of the object shall be given. Size, shape, complexity and identification of the
critical surfaces set many boundary conditions for a cleaning method.
Surface(s):
— material composition of the object surface(s);
— complexity;
— materials/critical materials (sensitive to cleaning agents);
— thin/atomic surface layers (e.g. protective layers);
— other physical properties (e.g. electrostatic).
The composition of the object could be simple (one or more similar material(s)) or a system consisting
of a range of different materials (e.g. metal/plastic/glass composition). Each individual material
should be taken into account when choosing a cleaning method. Some combinations of materials can
be very difficult to clean as one cleaning method may be suitable for one material but not the other.
The selection of the cleaning method shall be the best compromise between minimal damage of the
materials at maximum cleaning efficiency.
Chemical properties of the surface(s):
— chemical composition;
— state of the surface (hydrophobic, hydrophilic, lypophobic, lipophilic, etc.);
— energetic state of the surface (zeta potential).
Physical and chemical properties of a surface have a large influence on the choice of a cleaning method.
Choice of a method shall take into account all involved materials/chemical composition of the surface(s)
and the combination of materials undergoing cleaning.
The activity of the surface is determined by the chemical configuration of the final atomic layer. This is
an important parameter in determining the choice of method. These layers may be hydrophilic (water
wettable-lipophobic) or hydrophobic (water repellent but oil-wettable-lipophilic). The cleaning method
used can influence the surface activity. The surface activity also influences the electrostatic properties
of a material — a hydrophilic surface will have fewer tendencies to electrically charge.
Morphology:
Cleaning is influenced by the morphological aspects of a surface such as shape, size, structure, surface
roughness or porosity. Morphological aspects may further complicate cleaning due to the accessibility
of the surfaces to be cleaned and to the retention of cleaning agents and materials used for cleaning.
Object specific requirements:
— intended use of the object;
6 © ISO 2017 – All rights reserved

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SIST EN ISO 14644-13:2017
ISO 14644-13:2017(E)

— environmental conditions, both pre- and post-cleaning;
— critical surfaces — surfaces with either high importance in the application or sensitive to cleaning.
6 Cleanliness specifications
The rationale of determining appropriateness of the cleaning method should include the contaminants
of concern, as well as acceptable levels of contamination for the application.
The required cleanliness shall be specified in terms of particle concentration according to ISO 14644-9
and/or in terms of the concentration of a specific group of chemicals according to ISO 14644-10.
The specification of the targeted cleanliness class can be determined in various ways:
— cleanliness class required by customer;
— common cleanliness class required for similar objects;
— by performing an analysis on the impact of contamination of the surfa
...

SLOVENSKI STANDARD
oSIST prEN ISO 14644-13:2016
01-maj-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHOýLãþHQMHSRYUãLQ]D
GRVHJDQMHGRORþHQLKUDYQLþLVWRþHSRNODVLILNDFLMLGHOFHYLQNHPLNDOLM,62',6

Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to
achieve defined levels of cleanliness in terms of particle and chemical classifications
(ISO/DIS 14644-13:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 13: Reinigung von Oberflächen zur
Erreichung definierter Reinheitsgrade hinsichtlich Partikel- und
Chemikalienklassifikationen (ISO/DIS 14644-13:2016)
Salles propres et environnements maîtrisés apparentés - Partie 13: Nettoyage des
surfaces afin d'obtenir des niveaux de propreté par rapport aux classifications
particulaire et chimique (ISO/DIS 14644-13:2016)
Ta slovenski standard je istoveten z: prEN ISO 14644-13
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-13:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14644-13:2016

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oSIST prEN ISO 14644-13:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-13
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-02-11 2016-05-11
Cleanrooms and associated controlled environments —
Part 13:
Cleaning of surfaces to achieve defined levels of cleanliness
in terms of particle and chemical classifications
Salles propres et environnements maîtrisés apparentés —
Partie 13: Nettoyage des surfaces afin d’obtenir des niveaux de propreté par rapport aux classifications
particulaire et chimique
ICS: 13.040.35
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
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
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-13:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
Contents Page
Foreword . v
Introduction . vii
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General methodology . 5
4.1 Overview . 5
4.2 Methodology . 5
5 Object description . 7
6 Cleanliness specifications. 8
7 Determination of initial contamination level . 8
7.1 General . 8
7.2 Determination of initial contamination level with respect to particle concentration . 8
7.3 Determination of initial contamination level with respect to chemical concentration . 9
8 Other requirements . 9
9 Selection of a cleaning methodology . 9
9.1 Selection procedure . 9
9.2 Cleaning methodologies . 9
9.2.1 Cleaning method . 9
9.2.2 Categories of cleaning techniques . 10
9.3 Cleaning process . 10
10 Material compatibility check . 10
11 Cleaning validation . 11
11.1 General . 11
11.3 Cleaning efficacy . 14
11.3.1 Assessment . 14
11.3.2 Cleaning efficacy with respect to particle concentration . 14
11.3.3 Cleaning efficacy with respect to chemical concentration . 15
12 Measurement methods . 16
12.1 General . 16
12.2 Direct measurement methods . 16
12.2.1 Direct measurement methods with respect to SCP . 16
12.2.2 Direct measurement methods with respect to SCC . 16
12.3 Indirect measurement methods . 16
12.3.1 Indirect measurement methods with respect to SCP . 17
12.3.2 Indirect measurement methods with respect to SCC . 17
13 Documentation . 17
Annex A (informative) Aspects of cleaning . 19
Annex B (informative) Cleaning methods . 20
B.1 General . 20
B.2 Mechanical cleaning . 20
B.2.1 Wiping . 20
B.2.2 Brushing/Sweeping . 20
B.2.3 Scraping/Abrading . 21
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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
B.2.4 Grinding . 21
B.3 Fluidic cleaning . 21
B.3.1 Washing/Rinsing/Drying . 21
B.3.2 Compressed gas cleaning . 21
B.3.3 Vacuum cleaning . 21
B.3.4 Sonic cleaning . 22
B.3.5 Spray cleaning . 22
B.4 Blasting cleaning techniques . 22
B.4.1 General . 22
B.4.2 Gas blasting . 22
B.4.3 Liquid blasting . 23
B.5 Chemical cleaning . 24
B.5.1 General . 24
B.5.2 Etching . 24
B.5.3 Chemical reaction . 24
B.5.4 Vapour cleaning . 24
B.5.5 Plasma cleaning . 25
B.5.6 Ozone cleaning . 25
B.6 Working ranges of described cleaning techniques . 25
Annex C (informative) Material compatibility with cleaning agents . 28
Annex D (informative) Cleanliness measurement . 30
D.1 General . 30
D.2 Visual inspection . 30
D.3 Direct surface cleanliness measurement . 30
D.4 Indirect surface cleanliness measurement by extraction. 30
D.4.1 Extraction techniques . 31
D.4.2 Extraction from the object . 31
D.4.3 Extraction from the wipe . 31
D.5 Measurement methods . 31
D.5.1 Introduction . 31
D.5.2 Measurement methods for particles . 31
D.5.3 Measurement methods for chemical contamination . 33
Bibliography . 35

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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
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 14644-13 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, and by Technical Committee 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
classification
 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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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments –
Biocontamination control:
 Part [1]: General principles and methods
 Part [2]: Evaluation and interpretation of biocontamination data

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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
Introduction
‘Surface’ refers to the interface between two phases. For the purpose of this document, the surface is a solid.
“Clean surface” is where one or more of the contamination categories (particles, chemical) are under control
due to cleaning / decontamination. The degree of cleanliness is specified in the corresponding surface
cleanliness classifications (ISO 14644-9:2012 Surface cleanliness by particle concentration SCP; ISO 14644-
10:2013 Surface cleanliness by chemical concentration SCC). Different cleaning methods are necessary
depending on the degree of cleanliness (cleanliness class) required. This standard gives guidance on the
selection of cleaning methods to achieve specified cleanliness levels. For the selection procedure, the aspects
of surface description, cleanliness specifications, types of contamination, cleaning techniques, material
compatibility, and assessment methodology are taken into consideration. Most of the methods are suitable for
removal of more than one contamination category at the same time therefore a common standard for the
selection of a cleaning method for both particles as well as chemical contamination is needed.

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oSIST prEN ISO 14644-13:2016
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-13.7

Cleanrooms and associated controlled environments — Part 13:
Cleaning of surfaces to achieve defined levels of cleanliness in
terms of particle and chemical classification
1 Scope
The standard addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a
cleanroom and surfaces of materials in a cleanroom. It provides guidance on the assessment of cleaning
methods for achieving the required surface cleanliness by particle concentration (SCP) and surface
cleanliness by chemical concentration (SCC) classes and which techniques should be considered to achieve
these specified levels.
The efficacy of cleaning techniques will make reference to the cleanliness classes and associated test
methods found in ISO 14644-9:2012 and ISO 14644-10:2013.
The following matters of general guidance will be provided:
 expected surface cleanliness levels;
 suitability of cleaning methods;
 compatibility of surfaces with the cleaning technique;
 assessment of cleaning efficacy.
The following will be excluded from the standard:
 classification of cleaning methods
 product produced within a cleanroom;
 specific surface related cleaning methods;
 detailed description of cleaning mechanisms, methods and procedures of various cleaning methods;
 detailed material characteristics;
 description of damage mechanisms by cleaning processes and time-dependent effects;
 references to interactive bonding forces between contaminants and surfaces or generation processes that
are usually time-dependent and process-dependent;
 other characteristics of particles such as electrostatic charge, ionic charges etc.;
 chemical reactions between molecular contaminants and surfaces;
 microbiological aspects of surface cleanliness;
 radioactive aspects of contamination;
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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
 health and safety considerations;
 environmental aspects such as waste disposal, emissions etc.;
 selection and use of statistical methods.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 14644-8:2013, Cleanrooms and associated controlled environments — Part 8: Classification of air
cleanliness by chemical concentration (ACC)
ISO 14644-9:2012, Cleanrooms and associated controlled environments — Part 9: Classification of surface
cleanliness by particle concentration
ISO 14644-10:2013, Cleanrooms and associated controlled environments — Part 10: Classification of surface
cleanliness by chemical concentration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. Where a term has been defined
in all parts of ISO 14644 and the following apply:
3.1
cleanliness (of a solid surface)
condition of a solid surface where the amount of contamination (particle, chemical or viable) is controlled to a
specific level.
3.2
cleaning efficacy
the relation between the required cleanliness and the accomplished cleanliness under controlled conditions
Note to entry: In case of real operational conditions or monitoring, the term cleaning effectiveness is used.
3.3
cleaning efficiency
the fraction of specific contaminants removed from a surface by a cleaning process. The fraction is
determined by the accomplished surface cleanliness in respect to the initial surface cleanliness.
3.4
contamination
unwanted matter in an undesirable location.
3.5
chemical contamination
chemical (non-particulate) substances that can have a deleterious effect on the product, process or equipment
3.6
descriptor for specific particle size ranges
differential descriptor that expresses SCP level within specific particle size ranges
Note to entry: The descriptor may be applied to particle size ranges of special interest or those particle size ranges that
are outside the range of the classification system, and specified independently or as a supplement to the SCP classes.
2 © ISO 2015 – All rights reserved

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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
3.7
direct measurement method
assessment of the contamination without any intermediate steps
3.8
indirect measurement method
assessment of the contamination with intermediate steps
3.9
particle
minute piece of matter with defined physical boundaries
3.10
particle contamination
particles having the potential to affect the process, the product, the personnel or the facilities
3.11
particle size
length dimension describing the size of a three-dimensional particle

Note to entry 1: The particle size depends on the measurement method.
Note to entry 2: Different methods can be used to determine the particle size, e. g. the largest dimension, equivalent
diameter, smallest enclosed box.
3.12
particle size distribution
cumulative distribution of particle concentration as a function of particle size
[ISO 14644-9:2012]
3.13
solid surface
boundary between the solid and a second phase
3.14
surface
boundary between two phases; one of them is normally a solid phase and the other a gas, a liquid or another
solid
3.15
surface particle
solid and/or liquid matters adhered and discretely distributed on a surface of interest, excluding film-like
matters that cover the whole surface. They are adhered via chemical and/or physical interactions
3.16
surface cleanliness by particle concentration classification (SCP)
level (or the process of specifying or determining the level) that represents maximum allowable surface
concentrations, in particles per square metre, for considered sizes of particles, expressed in terms of an ISO
SCP Class N [ISO 14644-9:2012].
3.17
surface cleanliness by particle concentration class (SCP class)
grading number stating the maximum allowable surface concentration, in particles per square metre, for a
considered size of particles (SCP Classes 1 to 8)
3.18
surface particle concentration
number of individual particles per unit of area of surface under consideration
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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
3.19
surface cleanliness by chemical concentration class (SCC)
common logarithm (to the base of 10) of the chemical concentration on a surface in grams per square metre
2
(g/m ) [ISO 14644-10:2013]
The SCC class statement shall always be specified as to chemical substance or group of substances (x).
Note to entry: The format of SCC is SCC Class N (x).
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4 General methodology
4.1 Overview
Multiple aspects need to be considered for cleaning. Figure 1 provides an overview of the factors that
contribute to the suitability of cleaning methods to achieve a defined level of surface cleanliness. For more
details see Annex A.


Figure 1 — Overview of cleaning aspects
4.2 Methodology
Efficacy of a cleaning technique for an application depends on many factors. For complex objects it is advised
to follow the sequence described below and in the decision tree (Figure 2). By using this procedure it can be
assured that all important issues are covered. For simple objects and surfaces, deviations from the sequence
are allowable, as long as the critical information is documented.
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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7
The approach starts with describing the object that has to be cleaned. The description should cover, among
others, materials and surface finish and shape factors like geometrical complexity and size (step 1). In the
second step, the objective of the cleaning procedure is to be specified in terms of the desired cleanliness of
the object. To have a starting point, the initial contamination level should be assessed (step 3) and other
requirements shall be listed (step 4). Based on type of contaminants and the required removal efficiency, a
cleaning technique or a combination of techniques can be selected (step 5). The cleaning methodology shall
be checked against the materials from the first step in order to avoid material compatibility issues (step 6). At
the last step, a validation method shall be carried out (step 7). The validation shall at least comprise methods
for determination of the cleaning performance and material compatibility. The performance of the cleaning
shall be checked against the specification.


Figure 2 — Decision tree
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oSIST prEN ISO 14644-13:2016
ISO/DIS 14644-13.7

5 Object description
In the object description, the following aspects shall be considered:
Physical properties of the object:
 physical dimensions;
 form / shape / complexity of the object;
 critical surfaces.
A general description of the object shall be given. Size, shape, complexity, and identifi
...