EN ISO 14644-9:2022

Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)

This document establishes a procedure for the assessment of particle cleanliness levels on solid surfaces in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D.
This document applies to all solid surfaces in cleanrooms and associated controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The procedure for the assessment of surface cleanliness by particle concentration (SCP) is limited to particles of between 0,05 µm and 500 µm.
The following issues are not considered in this document:
—    requirements for the cleanliness and suitability of surfaces for specific processes;
—    procedures for the cleaning of surfaces;
—    material characteristics;
—    references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent;
—    selection and use of statistical methods for assessment and testing;
—    other characteristics of particles, such as electrostatic charge, ionic charges and microbiological state.

Reinräume und zugehörige Reinraumbereiche - Teil 9: Bewertung der partikulären Oberflächenreinheit (ISO 14664‑9:2022)

Dieses Dokument beschreibt ein Verfahren für die Bewertung der partikulären Reinheitsgrade auf festen Oberflächen für Anwendungen in Reinräumen und zugehörigen Reinraumbereichen. Empfehlungen zu Prüf- und Messverfahren sowie Angaben zu Oberflächenkenngrößen sind in Anhang A bis Anhang D enthalten.
Dieses Dokument ist anzuwenden für alle festen Oberflächen in Reinräumen und zugehörigen Reinraumbereichen, wie z. B. Wände, Decken, Fußböden, Arbeitsbereiche, Werkzeuge, Ausrüstungsgegenstände und Produkte. Das Verfahren für die Bewertung der partikulären Oberflächenreinheit (SCP, en: surface cleanliness by particle concentration) ist auf Partikel zwischen 0,05 µm und 500 µm begrenzt.
Die folgenden Punkte werden in diesem Dokument nicht behandelt:
   Anforderungen an die Reinheit und Eignung von Oberflächen für bestimmte Prozesse;
   Verfahrensweisen für die Reinigung von Oberflächen;
   Materialkenngrößen;
   Bezüge auf die wechselseitigen Bindungskräfte oder Entstehungsprozesse, die üblicherweise zeitabhängig und prozessabhängig sind;
   Auswahl und Anwendung statistischer Bewertungs- und Prüfverfahren;
   weitere Kenngrößen von Partikeln, wie z. B. elektrostatische Ladung, Ionenladungen und mikrobiologischer Zustand.

Salles propres et environnements maîtrisés apparentés - Partie 9: Évaluation de la propreté des surfaces en fonction de la concentration de particules (ISO 14644-9:2022)

Le présent document établit un mode opératoire pour l’évaluation des niveaux de propreté particulaire des surfaces solides, applicables aux salles propres et aux environnements maîtrisés apparentés. Les Annexes A à D fournissent des recommandations relatives aux essais et aux méthodes de mesurage, ainsi que des informations sur les caractéristiques des surfaces.
Le présent document s’applique à toutes les surfaces solides dans les salles propres et environnements maîtrisés apparentés telles que les murs, les plafonds, les sols, les environnements de travail, les outils, les équipements et les produits. Le mode opératoire d’évaluation de la propreté des surfaces par la concentration de particules (SCP) se limite à des tailles de particules comprises entre 0,05 µm et 500 µm.
Le présent document n’aborde pas les points suivants:
—    les exigences pour la propreté et l’adéquation des surfaces à des processus spécifiques;
—    les modes opératoires de nettoyage des surfaces;
—    les caractéristiques des matériaux;
—    les références aux forces de liaison ou aux processus de génération qui sont généralement fonction du temps et qui dépendent du procédé;
—    le choix et l’utilisation de méthodes statistiques pour l’évaluation et les essais;
—    d’autres caractéristiques des particules, telles que la charge électrostatique, les charges ioniques et l’état microbiologique.

Čiste sobe in podobna nadzorovana okolja - 9. del: Ocenjevanje čistosti površine na osnovi koncentracije delcev (ISO 14644-9:2022)

Ta dokument določa postopek za ocenjevanje stopenj čistosti delcev na trdnih površinah v čistih sobah in podobnih nadzorovanih okoljih. V dodatkih od A do D so navedena priporočila za preskušanje, merilne metode ter informacije o značilnostih površine. Ta dokument se uporablja za vse trdne površine v čistih sobah in podobnih nadzorovanih okoljih, kot so stene, stropi, tla, delovna okolja, orodja, oprema in izdelki. Postopek ocenjevanja čistosti površine s koncentracijo delcev (SCP) je omejena na delce velikosti od 0,05 μm do 500 μm. V tem dokumentu niso zajeti naslednji elementi: – zahteve glede čistosti in primernosti površin za specifične postopke; – postopki čiščenja površin; – značilnosti materialov; – sklicevanja na interaktivne sile spajanja ali postopke nastajanja, ki so običajno odvisni od časa in postopka; – izbira in uporaba statističnih metod za ocenjevanje in preskušanje; – druge značilnosti delcev, na primer elektrostatični naboj, naboji ionov in mikrobiološko stanje.

General Information

• Status: Published
• Publication Date: 24-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: 25-May-2022
• Completion Date: 25-May-2022
• Ref Project: SIST EN ISO 14644-9:2022 - Cleanrooms and associated controlled environments - Part 9: Assessment of surface cleanliness for particle concentration (ISO 14644-9:2022)

Relations

• Replaces: EN ISO 14644-9:2012 - Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)
• Effective Date: 25-Nov-2020

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 14644-9:2012
Čiste sobe in podobna nadzorovana okolja - 9. del: Ocenjevanje čistosti površine
na osnovi koncentracije delcev (ISO 14644-9:2022)
Cleanrooms and associated controlled environments - Part 9: Assessment of surface
cleanliness for particle concentration (ISO 14644-9:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 9: Klassifizierung der partikulären
Oberflächenreinheit (ISO 14644-9:2022)
Salles propres et environnements maîtrisés apparentés - Partie 9: Évaluation de la
propreté des surfaces en fonction de la concentration de particules (ISO 14644-9:2022)
Ta slovenski standard je istoveten z: EN ISO 14644-9:2022
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 14644-9
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-9:2012
English Version
Cleanrooms and associated controlled environments - Part
9: Assessment of surface cleanliness for particle
concentration (ISO 14644-9:2022)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 9:
- Partie 9: Évaluation de la propreté des surfaces en Klassifizierung der partikulären Oberflächenreinheit
fonction de la concentration de particules (ISO 14644- (ISO 14644-9:2022)
9:2022)
This European Standard was approved by CEN on 18 April 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 14644-9:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-9:2022) 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 14644-9:2012.
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 14644-9:2022 has been approved by CEN as EN ISO 14644-9:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-9
Second edition
2022-05
Cleanrooms and associated controlled
environments —
Part 9:
Assessment of surface cleanliness for
particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 9: Évaluation de la propreté des surfaces en fonction de la
concentration de particules
Reference number
ISO 14644-9:2022(E)
ISO 14644-9:2022(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 14644-9:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 The surface cleanliness level assessment system . 3
5.1 ISO-SCP grading level format . 3
5.2 Designation . 6
5.3 General information on surface cleanliness levels of particle concentration . 6
6 Demonstration of conformity .6
6.1 Principle . 6
6.2 Testing . 6
6.3 Test report . 7
Annex A (informative) Surface characteristics . 9
Annex B (informative) Descriptor for specific particle size ranges .12
Annex C (informative) Parameters influencing the SCP grading level assessments.15
Annex D (informative) Measurement methods for determining surface cleanliness by
particle concentration .17
Bibliography .26
iii
ISO 14644-9:2022(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 14644-9:2012), of which it constitutes a
minor revision. The changes are as follows:
— "Class" (classification, classified) has been changed to grade or assessment where appropriate;
— ISO 14644-6 has been removed from the opening text of Clause 3 and, as a result, Clause 2;
— entry 3.8 removed from Clause 3;
— ISO 4287 and ISO 4288 replaced by ISO 21920-2 and ISO 21920-3, respectively;
— ISO 16232-2, ISO 16232-3, ISO 16232-4 and ISO 16232-5 replaced by ISO 16232;
— 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
ISO 14644-9:2022(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear and life sciences (pharmaceuticals, medical devices, food, healthcare).
ISO 14644-1 to ISO 14644-8, ISO 14698-1 and ISO 14698-2 deal exclusively with airborne particle
and chemical contamination. Many factors, besides the assessment of surface cleanliness, should
be considered in the design, specification, operation and control of cleanrooms and other controlled
environments. These factors are covered in some detail in other parts of ISO 14644 and ISO 14698.
This document provides an analytical process for the determination and designation of surface
cleanliness levels based on particle concentration. This document also lists some methods of testing, as
well as procedure(s) for determining the concentration of particles on surfaces.
Where regulatory agencies impose supplementary guidelines o
...