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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
09-Aug-2017
Completion Date
09-Aug-2017

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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

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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.
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SIST EN ISO 14644-13:2017
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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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SIST EN ISO 14644-13:2017
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 14644-13:2017
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 2017 – All rights reserved iii
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ISO 14644-13:2017(E)

Bibliography .............................................................................................................................................................................................................................34

iv © ISO 2017 – All rights reserved
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SIST EN ISO 14644-13:2017
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 2017 – All rights reserved v
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SIST EN ISO 14644-13:2017
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
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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.;
© ISO 2017 – All rights reserved 1
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SIST EN ISO 14644-13:2017
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
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SIST EN ISO 14644-13:2017
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 2017 – All rights reserved 3
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SIST EN ISO 14644-13:2017
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
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SIST EN ISO 14644-13:2017
ISO 14644-13:2017(E)
Figure 2 — Decision tree
© ISO 2017 – All rights reserved 5
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SIST EN ISO 14644-13:2017
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
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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
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