EN ISO 14644-10:2022

Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination (ISO 14644-10:2022)

This document establishes appropriate testing processes to determine the cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions, atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.
NOTE 1    For the purpose of this document, consideration is only given to the chemical characteristics of a particle. The physical properties of the particle are not considered and this document does not cover the interaction between the contamination and the surface.
NOTE 2    This document does not include the contamination generation process or any time-dependent influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.

Reinräume und zugehörige Reinraumbereiche - Teil 10: Bewertung der chemischen Oberflächenreinheit (ISO 14644‑10:2022)

Dieses Dokument legt geeignete Prüfverfahren zur Bestimmung der Oberflächenreinheit in Reinräumen hinsichtlich vorhandener chemischer Verbindungen oder Elemente (einschließlich Molekülen, Ionen, Atomen und Partikeln) fest. Dieses Dokument ist auf alle festen Oberflächen in Reinräumen und zugehörigen Reinraumbereichen anwendbar, wie z. B. Wände, Decken, Fußböden, Arbeitsflächen, Werkzeuge, Ausrüstungsgegenstände und Geräte.
ANMERKUNG 1   Für die Anwendung dieses Dokuments werden nur die chemischen Eigenschaften eines Partikels in Betracht gezogen. Die physikalischen Eigenschaften des Partikels werden nicht berücksichtigt, und dieses Dokument behandelt nicht die Wechselwirkung zwischen der Kontamination und der Oberfläche.
ANMERKUNG 2   Dieses Dokument behandelt weder den Entstehungsprozess der Kontamination noch zeitabhängige Einflüsse (z. B. Ablagerung, Sedimentation, Alterung) oder prozessabhängige Tätigkeiten wie z. B. Transport und Handhabung. Auch enthält es keine Leitlinien zu statistischen Qualitätskontrollverfahren zur Sicherstellung der Übereinstimmung.

Salles propres et environnements maîtrisés apparentés - Partie 10: Évaluation de la propreté chimique des surfaces (ISO 14644-10:2022)

Le présent document définit les procédés d’essai appropriés afin de déterminer la propreté des surfaces dans les salles propres en fonction de la présence de composés ou éléments chimiques (molécules, ions, atomes et particules). Il s’applique à toute surface solide dans une salle propre ou un environnement maîtrisé apparenté, telle que les murs, plafonds, sols, surfaces de travail, outils, équipements et dispositifs.
NOTE 1        Il n’est tenu compte que des caractéristiques chimiques des particules aux fins du présent document. Leurs propriétés physiques sont ignorées et le présent document ne traite pas non plus les interactions entre la contamination et la surface.
NOTE 2        Le présent document n’inclut pas la génération de contamination ni aucune influence dépendant du temps (dépôt, sédimentation, vieillissement, etc.) ni aucune activité dépendant des procédés telle que le transport et la manipulation. Il ne comporte pas non plus de recommandations relatives aux techniques statistiques de maîtrise de la qualité permettant d’assurer la conformité.

Čiste sobe in podobna nadzorovana okolja - 10. del: Ocenjevanje čistosti površine na osnovi koncentracije onesnaževal (ISO 14644-10:2022)

Ta dokument določa ustrezne preskusne postopke za določanje čistosti površin v čistih sobah glede na prisotnost kemičnih spojin ali elementov (vključno z molekulami, ioni, atomi in delci). Ta dokument se uporablja za vse trdne površine v čistih sobah in podobnih nadzorovanih okoljih, kot so zidovi, stropi, tla, delovne površine, orodja, oprema in naprave. OPOMBA 1: V tem dokumentu so obravnavane le kemijske lastnosti delcev. Fizikalne lastnosti delcev niso upoštevane in ta dokument ne zajema medsebojnega vpliva med onesnaženostjo in površino. OPOMBA 2: Ta dokument ne vključuje postopka nastajanja onesnaženosti in morebitnih časovno odvisnih vplivov (nalaganje, usedanje, staranje) ali od postopkov odvisnih dejavnosti, kot sta prevoz in ravnanje. Prav tako ne vključuje smernic glede statističnih tehnik nadzora kakovosti za zagotavljanje skladnosti.

General Information

• Status: Published
• Publication Date: 17-May-2022
• Withdrawal Date: 29-Nov-2022
• 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: 18-May-2022
• Completion Date: 18-May-2022
• Ref Project: SIST EN ISO 14644-10:2022 - Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination (ISO 14644-10:2022)

Relations

• Replaces: EN ISO 14644-10:2013 - Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration (ISO 14644-10:2013)
• Effective Date: 25-May-2022

Overview

EN ISO 14644-10:2022 - "Cleanrooms and associated controlled environments - Part 10: Assessment of surface cleanliness for chemical contamination" (CEN endorsement of ISO 14644-10:2022) defines standardized approaches to test and report the chemical cleanliness of solid surfaces in cleanrooms and controlled environments. It applies to all solid surfaces (walls, ceilings, floors, worksurfaces, tools, equipment and devices) and establishes how to measure, express and grade chemical contamination on surfaces. The standard supersedes the 2013 edition and is part of the ISO 14644 series for cleanroom technology.

Key topics and requirements

• Scope and exclusions: Focuses solely on the chemical characteristics of contamination (molecules, ions, atoms and particles). It does not cover physical particle properties, surface–contaminant interactions, contamination generation, time-dependent deposition/ageing, process handling, or statistical quality‑control techniques.
• ISO‑SCC descriptor: Introduces the ISO‑SCC (Surface Cleanliness by Chemical Concentration) descriptor - a logarithmic grade (N) based on chemical concentration expressed in g/m². Thirteen grading levels are defined (0 to −12), where level 0 is highest contamination; intermediate increments of 0.1 are permitted.
• Unit conversions and reporting: Provides guidance to convert between unit expressions (g/m², μg/m², ng/m²) and, when needed, into atomic concentration units. Measurement results must be reported together with the chemical descriptor and the tested substance or substance group.
• Testing principles and documentation: Specifies principles for selecting test methods, sample handling, measurement procedures and essential documentation/reporting practices to demonstrate compliance with a predetermined SCC grade.
• Informative annexes: Includes conversion examples, parameters that influence testing and interpretation, recommended test methods, and templates for test records.

Practical applications and users

EN ISO 14644-10:2022 is intended for organizations that require objective assessment of surface chemical contamination, including:

• Pharmaceutical and biotech manufacturers (drug product contact surfaces)
• Semiconductor and microelectronics fabs (surface residues affecting yields)
• Medical device manufacturers and sterile processing
• Aerospace and optics industries (surface-sensitive assemblies)
• Cleanroom managers, QA/QC teams, validation engineers and third‑party testing laboratories

Using the standard helps:

• Define acceptance criteria for surface contamination (ISO‑SCC grades)
• Select suitable analytical methods and sample reporting formats
• Demonstrate compliance during qualification, validation and audits

Related standards

• ISO 14644 series (cleanroom design, classification and monitoring) - EN ISO 14644-1 (cleanroom classification) is particularly relevant when integrating chemical surface requirements with air cleanliness and operational controls.

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 14644-10:2013
Čiste sobe in podobna nadzorovana okolja - 10. del: Ocenjevanje čistosti površine
na osnovi koncentracije onesnaževal (ISO 14644-10:2022)
Cleanrooms and associated controlled environments - Part 10: Assessment of surface
cleanliness for chemical contamination (ISO 14644-10:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 10: Bewertung der chemischen
Oberflächenreinheit (ISO 14644‑10:2022)
Salles propres et environnements maîtrisés apparentés - Partie 10: Évaluation de la
propreté chimique des surfaces (ISO 14644-10:2022)
Ta slovenski standard je istoveten z: EN ISO 14644-10:2022
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 14644-10
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-10:2013
English Version
Cleanrooms and associated controlled environments - Part
10: Assessment of surface cleanliness for chemical
contamination (ISO 14644-10:2022)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 10: Évaluation de la propreté chimique des 10: Bewertung der chemischen Oberflächenreinheit
surfaces (ISO 14644-10:2022) (ISO 14644-10:2022)
This European Standard was approved by CEN on 1 May 2022.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-10:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-10:2022) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” 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 November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
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.
This document supersedes EN ISO 14644-10:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14644-10:2022 has been approved by CEN as EN ISO 14644-10:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-10
Second edition
2022-05
Cleanrooms and associated controlled
environments —
Part 10:
Assessment of surface cleanliness for
chemical contamination
Salles propres et environnements maîtrisés apparentés —
Partie 10: Évaluation de la propreté chimique des surfaces
Reference number
ISO 14644-10:2022(E)
ISO 14644-10:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 14644-10:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Testing and grading surface chemical levels . 2
4.1 Principles for testing the surface chemical contamination levels of clean surfaces
in cleanrooms and controlled environments . 2
4.2 ISO SCC descriptor format . 2
4.3 ISO-SCC grade level . 4
4.4 Converter for substances into surface atomic concentration . 4
5 Measuring the cleanliness of surfaces for chemical contamination and
demonstration of grade level compliance . 5
5.1 Criteria for good cleanliness assessment . 5
5.2 Documentation and reporting . 6
5.2.1 Principle . 6
5.2.2 Testing . 6
5.2.3 Test report . 6
Annex A (informative) Conversion between different unit expressions of surface
concentration for chemical substances . 8
Annex B (informative) Parameters influencing testing and interpretation of results .15
Annex C (informative) Essential considerations for a good cleanliness assessment.16
Annex D (informative) Methods for testing surface cleanliness for chemical concentration .17
Annex E (informative) Test record documentation .29
Bibliography .30
iii
ISO 14644-10:2022(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 14644-10:2013), of which it constitutes a
minor revision. The changes are as follows:
— the term class (classification, classified) changed to grade or assessment where appropriate;
— ISO 14644-1 moved from Clause 2 to the Bibliography and ISO 14644-6 removed (document
withdrawn);
— minor editorial changes.
A list of all parts in the ISO 14644 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
INTERNATIONAL STANDARD ISO 14644-10:2022(E)
Cleanrooms and associated controlled environments —
Part 10:
Assessment of surface cleanliness for chemical
contamination
1 Scope
This document establishes appropriate testing processes to determine the cleanliness of surfaces in
cleanrooms with regard to the presence of chemical compounds or elements (including molecules, ions,
atoms and particles). This document is applicable to all solid surfaces in cleanrooms and associated
controlled environments such as walls, ceilings, floors, worksurfaces, tools, equipment and devices.
NOTE 1 For the purpose of this document, consideration is only given to the chemical characteristics of
a particle. The physical properties of the particle are not considered and this document does not cover the
interaction between the contamination and the surface.
NOTE 2 This document does not include the contamination generation process or any time-dependent
influences (e.g. deposition, sedimentation, ageing) or process-dependent activities such as transportation and
handling. Neither does it include guidance on statistical quality-control techniques to ensure compliance.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
air cleanliness by chemical concentration
ACC
level, expressed as an ISO grade level N, which represents the maximum allowable concentration of a
given chemical species or group of chemical species, expressed in grams per cubic metre (g/m )
Note 1 to entry: This definition does not include macromolecules of biological origin, which are judged to be
particles.
3.2
contaminant category
common name for a group of compounds with a specific and similar deleterious effect when deposited
on the surface of interest
3.3
chemical contamination
chemical (non-particulate) substances that can have a deleterious effect on the product, process or
equipment
ISO 14644-10:2022(E)
3.4
solid surface
boundary between the solid phase and a second phase
3.5
surface
boundary between two phases
Note 1 to entry: One of the phases is normally a solid phase and the other a gas, a liquid or another solid.
3.6
surface cleanliness by chemical concentration
SCC
condition of a surface with respect to its chemical concentration
3.7
surface cleanliness by chemical concentration
N
SCC
common logarithm (to the base of 10) of the chemical concentration on a surface in
grams per square metre (g/m )
4 Testing and grading surface chemical levels
4.1 Principles for testing the surface chemical contamination levels of clean surfaces in
cleanrooms and controlled environments
The testing and grading levels shall be determined by the use of a descriptor designated “ISO-SCC”. This
is used to indicate the amount of total chemical concentration measured on a surface for an individual
chemical substance or group of substances. The SCC level is based upon the concentration of chemicals
on a surface as calculated using Formula (1) (given in 4.2) and expressed in g/m . For this calculation
all other units shall be converted to g/m . In specific cases where low concentrations need to be
determined, the concentration level of chemical on a surface may be expressed in atoms per square
centimetre, ISO-SCC , using Formula (2) in 4.4.
_atomic
4.2 ISO SCC descriptor format
The SCC level shall be designated by a grading number N , where N is the common logarithm index
SCC SCC
of concentration C , expressed in g/m . The SCC grade level statement shall always be connected with
SCC
a chemical substance or group of substances to which it is related. Thirteen distinct grading levels are
used from 0 to −12, where level 0 is most contaminated. Intermediate concentrations may be specified,
with 0,1 being the smallest permitted increment of N . C is determined from Formula (1), in terms
SCC SCC
of N :
SCC
N
SCC
C =10 (1)
SCC
Therefore, NC=log .
SCCS10 CC
C , the concentration of the specified chemical substance or group of substances, is expressed in g/
SCC
m . The measured chemical concentration on a surface shall not exceed the level of SCC, C to satisfy
SCC
the predetermined SCC that is agreed between the customer and the supplier.
In all cases, N grade level numbers shall include the negative sign.
SCC
NOTE 1 An SCC grade level number is only valid in connection with a descriptor (see 4.3).
NOTE 2 For converting from gravimetric concentration (g/m ) to numeric concentration (number of atoms,
molecules or ions per unit area), see 4.4.
ISO 14644-10:2022(E)
Table 1 and Figure 1 further illustrate the ISO-SCC designation as a function of chemical concentration
on a surface.
Note also the parameters listed in Annex B that influence measured chemical levels.
Table 1 — ISO-SCC grading levels
ISO-SCC level Concentration Concentration Concentration
2 2 2
g/m μg/m ng/m
0 6 9
0 10 10 10
−1 5 8
−1 10 10 10
−2 4 7
−2 10 10 10
−3 3 6
−3 10 10 10
−4 2 5
−4 10 10 10
−5 1 4
−5 10 10 10
−6 0 3
−6 10 10 10
−7 −1 2
−7 10 10 10
−8 −2 1
−8 10 10 10
−9 −3 0
−9 10 10 10
−10 −4 −1
−10 10 10 10
−11 −5 −2
−11 10 10 10
−12 −6 −3
−12 10 10 10
ISO 14644-10:2022(E)
Key
X surface mass concentration (g/m )
X surface mass concentration (μg/m )
X surface mass concentration (ng/m )
Y ISO-SCC grade level
Figure 1 — ISO-SCC grade levels as a function of concentration
4.3 ISO-SCC grade level
An SCC grade level is only valid in connection with a descriptor that includes the chemical substance
or group of substances for which this level number is valid. The ISO-SCC descriptor is expressed in the
format ISO-SCC Level N (X), where X is a chemical substance or group of chemical substances.
EXAMPLE 1 With an N-Methyl-2-pyrrolidone (NMP) sample, the measured value of chemical contamination
2 2
on a surface was 9,8E-7 g/m . This is within the grade level limit of 1E-6 g/m for Level −6. The designation
would be: “ISO-SCC Level −6 (NMP).”
EXAMPLE 2 With an organic compound sample, the measured value was 6E-5 g/m of total organic
compounds (TOC). This is within the grade level limit of 1E-4 g/m for Level −4. The designation would be: “ISO-
SCC Level −4 (TOC).”
4.4 Converter for substances into surface atomic concentration
Very low concentrations are usually measured in surface number concentrations in the units of number
of molecules, atoms or ions per surface area (1/m ). For grade level determination purposes, these
ISO 14644-10:2022(E)
should be converted into surface mass concentrations in the unit mass per surface area (g/m ). This
conversion is made using Formula (2):
MC()
SCC_number
C = (2)
SCC
N
a
where
C is the surface number concentration = number of molecules, atoms or ions per surface
SCC_number
area (1/m );
C is the surface mass concentration (g/m );
SCC
N is Avogadro’s number (6,02 × 10 /mol);
a
M is the molar mass of atomic, molecular or ionic species (g/mol).
For information purposes, Figure A.4 in Annex A illustrates the relationship between chemical
concentration on a surface (expressed in g/m ) and the atomic concentration on a surface (expressed in
atoms/m ) for typical substances.
5 Measuring the cleanliness of surfaces for chemical contamination and
demonstration of grade level compliance
5.1 Criteria for good cleanliness assessment
Figure D.2 in Annex D illustrates how to measure different types of contamination, showing differing
sampling and measuring methods.
Tests performed to demonstrate compliance shall be conducted in a laboratory environment where
the airborne chemical contaminant and the airborne particle contaminant levels do not negatively
influence the grade determination. Suitable measurement methods and calibrated instruments shall
be used for all tests. The environment, measurement methods and instruments shall be agreed upon
between customer and supplier.
Additional test essentials are discussed in Annex C, while Annex D details measurement methods for
demonstrating compliance.
The list of typical measurement methods is not exhaustive. Alternative methods that produce results
with comparable accuracy may be specified by agreement between customer and supplier.
Measurement by different methods, even when those methods are correctly applied, may produce
different results of equal validity.
Repeated measurements are recommended as part of the statistical approach.
Specific problems, such as concentration spikes, may occur when measuring high levels of cleanliness.
Special quality-control techniques will then be required, as explained in Figure D.4 in Annex D.
Precautions should be taken to reduce electrostatic charge around the test zone, as electrostatic charge
enhances chemical deposition onto surfaces. If the surface is neither conductive nor grounded or
charge-neutralized, electrostatic charges can occur. Therefore, test results can vary.
For typical methods of measurement for testing surface cleanliness by chemical concentration, refer to
Annex D.
ISO 14644-10:2022(E)
5.2 Documentation and reporting
5.2.1 Principle
Compliance with surface cleanliness chemical concentration (SCC) grade level requirement, as
specified by the customer, is verified by performing measurements and by providing documentation of
the results and conditions of measurement. Details for demonstrating compliance shall be agreed upon
between customer and supplier in advance.
5.2.2 Testing
Tests performed to demonstrate compliance shall be conducted using suitable measurement methods
together with calibrated instruments whenever possible.
Measurement methods for demonstrating compliance are described in Annex D. The list of typical
methods described is not exhaustive. The testing environment shall be agreed between customer and
supplier. Alternative methods of comparable accuracy also may be specified by agreement between
customer and supplier.
Measurement by different methods, even when correctly applied, may produce different results of
equal validity.
Repeated measurements are recommended.
The testing environment should be agreed between customer and supplier.
5.2.3 Test report
The results from testing each surface shall be recorded and submitted as a comprehensive report,
together with a statement of compliance or non-compliance to the required SCC grade level. The test
report shall include as a minimum the following:
a) name and address of the testing organization;
b) name of the person performing the test;
c) measurement environment;
d) date, time and duration of sampling;
e) time of measurement;
f) a reference to this document, i.e. ISO 14644-10:2022;
g) clear identification of the location of the surface measured and specific designations for coordinates
of the surface, if applicable;
h) surface cleanliness by chemical concentration level with designation expressed as SCC grade level
N;
i) acceptance criteria for the clean surface if agreed between customer and supplier;
j) specified measurement method(s), equipment resolution and detection limits;
k) details of the test procedure used, with any available data describing deviations from the test
procedure (if agreed);
l) identification of the instrument(s) used and current calibration certificate(s);
m) number of measurements performed;
ISO 14644-10:2022(E)
n) test results, including chemical concentration(s) data for given substances, for all measurements
performed;
o) surface condition, i.e. after final cleaning, before or after packaging, with agreement on type and
quality of packaging required.
An example of how this test report may be constructed can be found in Annex E. Other variations of the
test report which are agreeable to both the customer and supplier may be used.
ISO 14644-10:2022(E)
Annex A
(informative)
Conversion between different unit expressions of surface
concentration for chemical substances
A.1 Principle
In addition to the unit of surface mass concentration of g/m , there exist several different units
to express surface number concentration of an organic compound or a group of organics such as
2 2
molecules/m , based on a number of organic molecules, and atoms C/m , based on a number of atoms of
carbon composing organic compound(s) under consideration for each contaminant category.
A.2 Examples
For information purposes, Tables A.1 to A.3 illustrate how the different units of surface number
2 2
concentrations (molecules/m or atoms C/m ) can be converted into surface mass concentrations in
2 2
terms of carbon (g C/m ) or whole compound (g/m ), respectively, using the examples of heptane,
hexadecane and di (2-ethylhexyl) phthalate.
Table A.1 — Illustration of the relationship between unit of surface concentration [g/m ] and
2 2
surface number concentration [molecules/m , atoms C/m ] for heptane (C H ), CAS No. 142–
7 16
82–5
Symbol Unit M = 100,2, N = 7
c
Example 1 Example 2 Example 3 Example 4
Surface number mo-
C [molecules/m ] 1,00E+19 1,42E+18 7,16E+16 6,01E+16
molecule
lecular concentration
Surface number con-
centration in terms C [atoms C/m ] 7,00E+19 1,00E+19 5,00E+17 4,19E+17
carbon_number
of carbon
Surface mass concen-
tration in terms of C [g C/m ] 1,39E-3 1,98E-4 1,00E-4 8,39E-6
carbon_mass
carbon
Surface mass concen-
C [g/m ] 1,66E-3 2,36E-4 1,19E-4 1,00E-6
SCC
tration
ISO 14644-10:2022(E)
Table A.2 — Illustration of the relationship between unit of surface concentration [g/m ] and
2 2
surface number concentration [molecules/m , atoms C/m ] for hexadecane (C H ), CAS No.
17 34
544–76–3
Symbol Unit M = 226,4, N = 17
c
Example 1 Example 2 Example 3 Example 4
Surface number mo-
C [molecules/m ] 1,00E+19 6,20E+18 3,12E+16 2,60E+16
molecule
lecular concentration
Surface number con-
centration in terms C [atoms C/m ] 1,59E+20 1,00E+19 5,00E+17 4,20E+17
carbon_atom
of carbon
Surface mass concen-
tration in terms of C [g C/m ] 3,19E-3 2,00E-4 1,00E-4 8,49E-6
carbon_mass
carbon
Surface mass concen-
C [g/m ] 3,77E-3 2,35E-4 1,17E-4 1,00E-4
SCC
tration
Table A.3 — Illustration of the relationship between unit of surface concentration [g/m ] and
2 2
surface number concentration [molecules/m , atoms C/m ] for di (2-ethylhexyl) phthalate
(C H O ), CAS No. 117–817–7
24 38 4
Symbol Unit M = 390,6, N = 24
c
Example 1 Example 2 Example 3 Example 4
Surface number molecular
C [molecules/m ] 1,00E+19 4,20E+18 2,00E+16 1,50E+16
molecule
concentration
Surface number concentration C
carbon_ 2
[atoms C/m ] 2,39E+20 1,00E+19 4,89E+17 3,60E+17
in terms of carbon
atom
Surface mass concentration in C
carbon_ 2
[g C/m ] 4,89E-3 2,04E-4 1,00E-4 7,37E-6
terms of carbon
mass
Surface mass concentration C [g/m ] 6,62E-3 2,76E-4 1,35E-4 1,00E-4
SCC
Each surface number concentration can be converted to the original surface concentration from
Formulae (A.1) to (A.3):
M[]gm/ ol
   
CCgm//= moleculesm × (A.1)
SCCmolecule
   
N molecules//mol
[]
a
 
C atoms Cm/
carbon _ atom M gm/ ol
[]
2  
 
C gm/ = × (A.2)
SCC
 
N [atoms Cm/ olecule]] N []moleculesm/ ol
c a
 
C [/g Cm ]
carbon _mass
 
 M [g /mol] 
 
2 c
 
C gm/ = ×M [g /mol] (A.3)
SCC
 
N [atoms C/molecule]
c
where
N is the number of carbon composing organic compound(s) under consideration;
c
M is the molar mass of carbon.
c
ISO 14644-10:2022(E)
Surface number concentration with different types of unit expression based on Langmuir–Blodgett (LB)
film for typical organics is also listed in Table A.4. The surface number concentration can be obtained
from Formula (A.4):
2 13//23
 
CMgm/(= /)Nd (A.4)
SCCL_ Ba
 
where d is the density of organic compound(s) in g/m .
Table A.4 — Monolayer concentration based on Langmuir–Blodgett film
Di (2-ethylhexyl)
Heptane (C H ), Hexadecane (C H ),
7 16 17 34
phthalate (C H O ),
24 38 4
CAS No. 142–82–5 CAS No. 544–76–3
CAS No. 117–817–7
Surface number molecular con-
2,55E+18 1,62E+18 1,34E+18
centration
Surface number concentration
1,79E+19 2,59E+19 3,21E+19
in terms of carbon
Surface mass concentration in
3,56E-4 5,18E-4 6,56E-4
terms of carbon
Surface mass concentration 4,24E-4 6,10E-4 8,88E-4
For information purposes, Figures A.1 to A.4 illustrate how the different units of surface number
2 2
concentrations (molecules/m or atoms C/m ) can be converted into surface mass concentrations in
2 2
terms of carbon (g C/m ) or whole compound (g/m ), respectively.
ISO 14644-10:2022(E)
Key
2 2
X surface molecular concentration (molecules/m ) [surface molecular concentration (molecules/cm )]
2 2
Y surface mass concentration (g/m ) [surface mass concentration (g/cm )]
surface concentration corresponding to monolayer based on LB model
1 heptane (C H ), CAS No. 142-82-5
7 16
2 hexadecane (C H ), CAS No. 544-76-3
17 34
3 di (2-ethylhexyl) phthalate (C H O ), CAS No. 117-817-7
24 38 4
Figure A.1 — The r
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