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)

ISO 14644-13:2017 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.;
-      selection and use of statistical methods.

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
• Publication Date: 08-Aug-2017
• Withdrawal Date: 27-Feb-2018
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 09-Aug-2017
• Completion Date: 09-Aug-2017
• Ref Project: 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)

Relations

• Revised: prEN ISO 14644-13 - Cleanrooms and associated controlled environments - Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical concentration (ISO/FDIS 14644-13:2025)
• Effective Date: 17-Mar-2025

Overview

EN ISO 14644-13:2017 - Cleanrooms and associated controlled environments - Part 13 - provides guidance for cleaning of surfaces in cleanrooms and controlled environments to achieve defined levels of surface cleanliness. The standard focuses on achieving specified cleanliness in terms of surface cleanliness by particle concentration (SCP) and surface cleanliness by chemical concentration (SCC). It guides the assessment and selection of cleaning techniques for all surfaces (external and internal) of interest in cleanroom systems and equipment.

Key topics and requirements

• Scope and purpose: Guidelines for cleaning to a specified degree on cleanroom surfaces, equipment surfaces and materials in cleanrooms.
• Cleanliness classifications: Uses surface cleanliness classes (SCP, SCC) as the target criteria for cleaning outcomes.
• General methodology: Steps for describing objects/surfaces, defining cleanliness specifications, determining initial contamination levels, and selecting cleaning approaches.
• Selection of cleaning methodology: Guidance on choosing cleaning methods and techniques based on required cleanliness class, contamination type, and surface compatibility.
• Material compatibility checks: Considerations to verify that cleaning agents and methods are compatible with surface materials.
• Cleaning validation and appropriateness: Methods to evaluate cleaning efficiency and demonstrate that chosen procedures achieve SCP and SCC targets.
• Measurement methods: Direct and indirect measurement approaches for assessing particle and chemical surface contamination.
• Documentation: Recording requirements for cleaning procedures, validation results and assessments.
• Exclusions: The standard explicitly excludes classification of cleaning methods, microbiological aspects, health & safety, detailed cleaning mechanisms, environmental disposal requirements and statistical methods.

Applications and who uses it

EN ISO 14644-13:2017 is practical for organizations that operate controlled environments and need documented evidence that surface-cleaning achieves quantitative cleanliness targets:

• Cleanroom managers and facility engineers
• Validation and quality assurance teams
• Pharmaceutical, biotechnology and medical device manufacturers
• Semiconductor and microelectronics fabs
• Aerospace component manufacturers
• Suppliers of cleanroom cleaning materials and equipment

Use cases include selecting appropriate cleaning procedures for sensitive equipment, validating cleaning effectiveness against SCP/SCC classes, and documenting cleaning strategies for audits and regulatory compliance.

Related standards

• ISO 14644-9 - Surface cleanliness: particle concentration (referenced for SCP)
• ISO 14644-10 - Surface cleanliness: chemical concentration (referenced for SCC)
• Other parts of the ISO 14644 series for broader cleanroom design, testing and classification

EN ISO 14644-13:2017 helps link cleaning practice to measurable surface cleanliness outcomes, enabling repeatable, auditable cleaning programs in controlled environments.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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
ISO 14644-13:2017(E)
© 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

ISO 14644-13:2017(E)
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
ISO 14644-13:2017(E)
Bibliography .34
iv © ISO 2017 – All rights reserved

ISO 14644-13:2017(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: 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 14644-13:2017(E)
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.
vi © ISO 2017 – All rights reserved

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.;
ISO 14644-13:2017(E)
— 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]
2 © ISO 2017 – All rights reserved

ISO 14644-13:2017(E)
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)
ISO 14644-13:2017(E)
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.
4 © ISO 2017 – All rights reserved

ISO 14644-13:2017(E)
Figure 2 — Decision tree
ISO 14644-13:2017(E)
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

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 surface in the (future) function of
a product or process where the cleaned surface will be used;
— by performing tests or simulations with various cleanliness classes of the considered surface and/or;
— by performing an analysis of the contamination that caused failure or quality loss.
7 Determination of initial contamination level
7.1 General
To select the cleaning procedure for achieving a required surface cleanliness level, the initial surface
cleanliness shall be established. The initial surface cleanliness by chemical and/or particle concentration
shall be determined for the surfaces of interest. This can be determined qualitatively or quantitatively.
Qualitative evaluation is a non-numerical assessment (e.g. a visual inspection).
Where the quantitative surface cleanliness is determined, it can be related to the efficiency of the
cleaning procedure in respect to the required surface cleanliness by particle concentration and/or
chemical concentration. The quantified contamination (particle and/or chemical) shall be related to the
area of the representative surface. This evaluation allows determination of the initial cleanliness class.
7.2 Determination of initial contamination level with respect to particle concentration
The initial surface cleanliness by particle concentration shall be determined for the different surfaces.
Depending on the required cleanliness class, a qualitative assessment of the initial cleanliness level
may be sufficient. For quantitative assessment, the number and size of particles shall be characterized
by a measurement method as described in Clause 12. The surface cleanliness classification as outlined
in ISO 14644-9 shall be applied.
The quantified particle concentration shall be related to the area of the representative surface. This
evaluation allows determination of the initial cleanliness class.
7.3 Determination of initial contamination level with respect to chemical concentration
The initial surface cleanliness by chemical concentration shall be determined for the different surfaces.
Depending on the specific application, a qualitative assessment (e.g. water break test) of the initial
cleanliness level might be sufficient. For quantitative assessment of the mass and nature of the chemical
contaminants, a measurement technique according to Clause 12 and ISO 14644-10 shall be applicable.
ISO 14644-13:2017(E)
The quantified chemical contamination shall be related to the area of the representative surface. This
evaluation allows determination of the initial cleanliness class.
8 Other requirements
In addition to requirements for cleaning appropriateness and product integrity, many other elements
influence the applicability of the cleaning method. In step 5 of the decision tree (see Figure 2), these
other aspects shall be listed and requirements shall be defined. The contents of these requirements are
strongly related to the object or surface and its application.
Typical examples for other requirements are time available for cleaning, number of items that
will be cleaned, available footprint, waste, investment and labour costs, level of operator skill and
environmental aspects.
9 Selection of a cleaning methodology
9.1 Selection procedure
Requirements for cleaning are defined in Clause 5 to Clause 8. These requirements shall be considered
during the selection process for the cleaning methodology to ensure the greatest uniformity between
the requirements and the method.
The final decision of the choice of cleaning methodology shall be based on a combination of all aspects to
find the technically and financially optimal, most efficient solution. The customer, the clean technology
supplier and the process owner of the surface/object/component to be cleaned should be involved in
this selection process. The decision optimizes the various parameters and shall assure specified surface
quality. Table B.1 and Table B.2 can aid the selection process.
9.2 Cleaning methodologies
9.2.1 Cleaning method
A cleaning methodology consists of a cleaning technique (e.g. wiping, plasma cleaning and ultrasonic
cleaning) and a cleaning process. The cleaning process is linked to the cleaning techniques and involves
the amount of mechanical energy, chemical energy, temperature and process time. By using a balanced
combination of these four process parameters, the optimum cleaning result can be achieved. Final
cleanliness can be limited by substrate damage and/or selection criteria defined in Clause 8.
The required cleanliness level and the initial cleanliness level in particle and/or chemical concentration
lead to a selection of cleaning methods. In case the initial cleanliness class is high and the required
cleanliness class is low, a combination of methods may be required.
9.2.2 Categories of cleaning techniques
The cleaning techniques can be divided depending on the major cleaning mechanism into physical and
chemical cleaning which additionally could be divided into wet and dry cleaning techniques. Whether
a process is categorized as physical/chemical or as wet/dry depends on the dominant mechanism used
for the cleaning. A non-exhaustive list of physical cleaning techniques can be found in B.2 (mechanical
cleaning), B.3 (fluidic cleaning), and B.4 (blasting cleaning techniques). A list of chemical cleaning
techniques can be found in B.5 (chemical cleaning). References to the categories of cleaning techniques
are given in Table 1.
8 © ISO 2017 – All rights reserved

ISO 14644-13:2017(E)
Table 1 — Categorization of cleaning techniques as described in Annex B
Cleaning technique Physical Chemical
Dry B.2, B.4 dry B.5 dry
Wet B.3, B.4 wet B.5 wet
The numbers refer to subclauses within Annex B that provide a brief description of the major cleaning
techniques.
Table B.1 and Table B.2 support the choice of an appropriate cleaning technique (physical/chemical)
that fulfils the cleanliness specifications. With the help of feasibility tests on material compatibility (see
Clause 10) and empirical values/evaluation, the best suitable technique shall be chosen for validation
(see Clause 11).
9.3 Cleaning process
In Table B.1 and Table B.2, an overview is given on the working ranges for different cleaning
techniques. In these ranges, optimum process conditions are assumed. Since material properties and
other requirements might force use of less than optimal conditions, the actual cleaning efficiency
and appropriateness might be lower. The process settings shall be defined either by an experimental
investigation or from experience.
10 Material compatibility check
The compatibility of materials with cleaning agents shall be considered. These cleaning agents (e.g.
chemicals, solvents, high pressure gas or liquid) shall be selected with respect to their compatibility with
the materials or items to be cleaned and their efficiency in removing different kinds of contaminants:
particle or chemical contaminants.
Detrimental effects on surfaces can be caused by the cleaning agents and/or the cleaning technique.
The chemical nature of the materials of the surface — individually or in combination depending on the
composition of the surface — should be evaluated technically.
The following describes such direct, indirect and long duration effects.
— Direct effects are changes of intrinsic material properties (physical and/or chemical) as a
consequence of the interaction with a process parameter from the cleaning technique: chemical
nature of a solvent, time of exposure and temperature.
EXAMPLE 1 The change of the chemical surface structure may strongly change the physical
behaviour. Change of the hydrophilic character of the last atomic layer to hydrophobic through the cleaning
process may change the physical behaviour of the cleaned surface, i.e. wettability and electrostatic charge.
Hydrophobic surface is not wettable and is easily charged which may attract particles.
EXAMPLE 2 Change in surface roughness.
— Indirect effects can be caused by different physical-chemical mechanisms as a consequence of
secondary interactions (e.g. chemical reactions with specific compounds of the substrate) or as an
interaction with a non-process parameter (post-degradation or oxidation by O of air, deposits of
residues as a new contamination).
NOTE An indirect effect might not be observed immediately.
— Long duration effects result from a slow process (e.g. induced corrosion from chemical conversion
after chemical cleaning, ageing and weakening).
Annex C gives an overview of compatibility with chemical solvents; it is a non-exhaustive list. In the
case of a lack of information for a specific cleaning solvent, the chemical resistance of the material shall
be assessed through an appropriate test.
ISO 14644-13:2017(E)
11 Cleaning validation
11.1 General
To assess the suitability of a selected cleaning procedure, the cleaning efficiency and the cleaning
appropriateness should be considered.
For the validation of a cleaning process to reach the required surface cleanliness with respect to
particle concentration and/or chemical concentration, the achieved surface cleanliness SCP and/or SCC
levels should be determined.
Other performance-related aspects, such as repeatability, reproducibility and operator influences,
shall also be considered. In Clause 8, a set of requirements are defined that are not related to cleaning
performance. Although these requirements are taken into account during the selection of the cleaning
method, the validation process shall verify that these requirements are fulfilled.
Figure 3 and Figure 4 are depictions of the terms cleaning efficiency and cleaning appropriateness.
Cleaning efficiency = 1 − final cleanliness level/initial cleanliness level (expressed as a percentage)
Cleaning appropriateness = required cleanliness level/final cleanliness level
Figure 3 — Example for a method with low cleaning efficiency leading to unsuitable cleaning
appropriateness
Figure 4 — Example for a method with high cleaning efficiency leading to suitable cleaning
appropriateness
10 © ISO 2017 – All rights reserved

ISO 14644-13:2017(E)
11.2 Cleaning efficiency
11.2.1 Evaluation
For evaluation of the cleaning efficiency, the initial surface cleanliness level and final cleanliness level
shall be determined.
11.2.2 Cleaning efficiency with respect to particle concentration
The cleaning efficiency is calculated by Formula (1):
fin
C
SCP;D
C =−1 (1)
eff
ini
C
SCP;D
where
D is the particle size, in micrometres (µm);
is the initial surface concentration, in particles per square metre of surface, of particles that
ini
C
SCP;D
are equal to or larger than the considered particle size D in µm;
is the final surface concentration, in particles per square metre of surface, of particles that
fin
C
SCP;D
are equal to or larger than the considered particle size D in µm.
In accordance with ISO 14644-9, the relation with the surface cleanliness class is given by Formula (2):
SCP;N
Ck= (2)
SCP;D
D
where
C is the maximum permitted total surface concentration, in particles per square metre of
SCP;D
surface, of particles that are equal to or larger than the considered particle size;
SCP;N is the SCP classification number;
D is the considered particle size, in micrometres;
k is the constant 1, in micrometres.
Combining Formula (1) and Formula (2) gives the cleaning efficiency in terms of SCP, in Formula (3):
SCP;N
fin
k
SCP;N
fin
SCP;NN− SCP;
()
D
finini
C =−1 = 1− = 11− 0 (3)
eff
SCP;N SCP;N
ini ini
k
D
where
D is the particle size, in micrometres;
SCP;N is the SCP classification number;
SCP;N is the SCP classification number of the final surface cleanliness of particles;
fin
SCP;N is the SCP classification number of the initial surface cleanliness of particles.
ini
NOTE The cleaning efficiency can also be expressed as a percentage (%).
ISO 14644-13:2017(E)
EXAMPLE In this example, the smallest particle size that could be measured with the applied measurement
method is 5 µm. Therefore, the concentration of the number of particles ≥5 µm is used.
ini
The initial concentration of particles ≥5 µm per m C is 600 000. Therefore, the SCP;N = lg (600 000 × 5) = 6,5.
ini
SCP;5
The initial surface cleanliness class number SCP;N = 6,5 for particles equal to or larger than 5 µm.
ini
fin
After cleaning, the final concentration of particles ≥5 µm per m C is 1 000. Therefore, the
SCP;5
SCP;N = lg (1 000 × 5) = 3,7.
fin
The final surface cleanliness class number SCP;N = 3,7 for particles equal to or larger than 5 µm.
fin
The cleaning efficiency in terms of particle concentration = 1 − (1 000)/(600 000) = 1 − 1/600 = 0,998 or 99,8 %
for particles ≥5 µm.
(3,7 − 6,5) -2,8
Similarly, the cleaning efficiency in respect to the SCP class numbers = 1 − 10 = 1 – 10 = 0,998 4 or
99,8 % for particles ≥5 µm.
11.2.3 Cleaning efficiency with respect to chemical contamination
The cleaning efficiency is calculated by Formula (4):
fin
C
SCC
C =−1 (4)
eff
ini
C
SCC
where
is the initial concentration of the considered chemical (g/m );
ini
C
SCC
is the final concentration of the considered chemical (g/m ).
fin
C
SCC
According to ISO 14644-10, the relation with the surface cleanliness class by chemical concentration
(SCC) is given by Formula (5):
SCC;N
C = 10 (5)
SCC
where
SCC;N is the surface cleanliness of chemical concentration by classification number.
Combining Formula (4) and Formula (5) gives the cleaning efficiency in terms of SCC, in Formula (6):
SCC;N
fin
()SCC;NN−SCC;
finini
C =−1 = 11− 0 (6)
eff
SCC;N
ini
12 © ISO 2017 – All rights reserved

ISO 14644-13:2017(E)
NOTE The cleaning efficiency can also be expressed as a percentage (%).
EXAMPLE The initial concentration of the hydrocarbons is 50 mg per m for hydrocarbons.
Therefore, the
−3
SCC;N =×lg 50 10 =−13,
( )
ini
for hydrocarbons.
The final concentration of the hydrocarbons is 10 µg per m .
Therefore, the
−6
SCC;N =×��lg 10 10 =−� 50, .
( )
fin
The cleaning efficiency in terms of chemical concentration =
−6 −6
1 − 10 × 10 /50 × 1 000 × 10 = 1 − 10/50 000 = 0,999 8 or 99,98 % for hydrocarbons.
(−5,0 + 1,3) −3,7
Similarly, the cleaning efficiency in respect to the SCC classes = 1 − 10 = 1 − 10 = 0,999 8 or 99,98 %
for hydrocarbons.
11.3 Cleaning appropriateness
11.3.1 Assessment
For evalua
...