EN ISO 14644-8:2022
(Main)Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
Cleanrooms and associated controlled environments - Part 8: Assessment of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
This document establishes typical assessment processes to determine grading levels of air chemical cleanliness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category), and provides a protocol to include test methods, analysis and time-weighted factors for their determination. This document currently considers only concentrations of air chemical contaminants between 100 g/m3 and 10−12 g/m3 under cleanroom operational conditions.
This document is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances is not considered a risk to the product or process.
It is not the intention of this document to describe the nature of air chemical contaminants.
This document does not give a classification of surface chemical contamination.
Reinräume und zugehörige Reinraumbereiche - Teil 8: Bewertung der chemischen Luftreinheit (ACC) (ISO 14644‑8:2022)
Dieses Dokument beschreibt die typischen Beurteilungsprozesse zur Bestimmung der Bewertungsstufen für die chemische Luftreinheit (ACC) in Reinräumen und zugehörigen Reinraumbereichen hinsichtlich der luftgetragenen Konzentrationen spezifischer chemischer Substanzen (einzeln, gruppenweise oder als Kategorien) und stellt ein Protokoll zur Verfügung, um Prüfverfahren, Analyse und Zeitgewichtungsfaktoren in die Bestimmung einzuschließen. Dieses Dokument betrachtet ausschließlich Konzentrationen von luftgetragenen chemischen Kontaminanten zwischen 100 g/m3 und 10−12 g/m3 unter Reinraumbetriebsbedingungen.
Dieses Dokument ist nicht anwendbar bei solchen Industriezweigen, Prozessen oder Produktionen, bei denen oder bei der das Vorhandensein von luftgetragenen chemischen Substanzen nicht als Risiko für das Produkt oder den Prozess betrachtet wird.
Es ist nicht Ziel dieses Dokuments, die Beschaffenheit luftgetragener chemischer Kontaminanten zu beschreiben.
Dieses Dokument gibt keine Klassifizierung für chemische Oberflächenkontamination vor.
Salles propres et environnements maîtrisés apparentés - Partie 8: Évaluation de la propreté chimique de l'air (ISO 14644-8:2022)
Le présent document établit les processus types d’évaluation permettant de déterminer les niveaux de gradation de la propreté chimique de l’air (ACC) dans les salles propres et les environnements maîtrisés apparentés, en termes de concentrations aéroportées de substances chimiques spécifiques (individuelle, groupe ou catégorie), et fournit un protocole permettant d’intégrer les méthodes d’essai, l’analyse et les facteurs de pondération pour leur détermination. Le présent document ne prend actuellement en compte que les concentrations de contaminants chimiques dans l’air comprises entre 100 g/m3 et 10−12 g/m3 dans des conditions d’exploitation de salles propres.
Le présent document ne s’applique pas aux secteurs industriels, aux procédés ou aux types de production où la présence de substances chimiques en suspension dans l’air n’est pas considérée comme un risque pour le produit ou le procédé.
Le présent document ne vise pas à décrire la nature des contaminants chimiques dans l’air.
Le présent document ne fournit pas de classification de la contamination chimique des surfaces.
Čiste sobe in podobna nadzorovana okolja - 8. del: Ocenjevanje čistosti zraka na osnovi koncentracije onesnaževal v zraku (ACC) (ISO 14644-8:2022)
Ta dokument določa tipične postopke ocenjevanja za določanje stopenj kemijske čistosti zraka (ACC) v čistih sobah in podobnih nadzorovanih okoljih v smislu koncentracij različnih kemijskih snovi v zraku (posameznih, skupin ali vrst) ter določa protokol
za vključitev preskusnih metod, analiz in časovno prilagojenih faktorjev v postopek njihovega določanja. Ta dokument trenutno obravnava samo kemijske onesnaževalce zraka v koncentraciji med 100 g/m3 in 10–12 g/m3
v obratovalnih pogojih čiste sobe.
Ta dokument se ne uporablja za industrije, procese in proizvodnje, kjer se prisotnost kemijskih snovi v zraku ne šteje za nevarno proizvodu ali procesu.
Ta dokument ni namenjen opisovanju lastnosti kemijskih onesnaževalcev zraka.
Ta dokument ne vsebuje klasifikacije kemijske onesnaženosti površja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Nadomešča:
SIST EN ISO 14644-8:2014
Čiste sobe in podobna nadzorovana okolja - 8. del: Ocenjevanje čistosti zraka na
osnovi koncentracije onesnaževal v zraku (ACC) (ISO 14644-8:2022)
Cleanrooms and associated controlled environments - Part 8: Assessment of air
cleanliness by chemical concentration (ACC) (ISO 14644-8:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifizierung der Luftreinheit
anhand der Chemikalienkonzentration (ACC) (ISO 14644-8:2022)
Salles propres et environnements maîtrisés apparentés - Partie 8: Évaluation de la
propreté chimique de l'air (ISO 14644-8:2022)
Ta slovenski standard je istoveten z: EN ISO 14644-8:2022
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 14644-8
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2022
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-8:2013
English Version
Cleanrooms and associated controlled environments - Part
8: Assessment of air cleanliness by chemical concentration
(ACC) (ISO 14644-8:2022)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 8:
- Partie 8: Évaluation de la propreté chimique de l'air Klassifizierung der Luftreinheit anhand der
(ISO 14644-8:2022) Chemikalienkonzentration (ACC) (ISO 14644-8:2022)
This European Standard was approved by CEN on 4 June 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 14644-8:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-8:2022) 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 January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.
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 14644-8:2013.
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 14644-8:2022 has been approved by CEN as EN ISO 14644-8:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-8
Third edition
2022-06
Cleanrooms and associated controlled
environments —
Part 8:
Assessment of air cleanliness by
chemical concentration (ACC)
Salles propres et environnements maîtrisés apparentés —
Partie 8: Évaluation de la propreté chimique de l'air
Reference number
ISO 14644-8:2022(E)
ISO 14644-8:2022(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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 14644-8:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Contaminant categories . 2
4 Testing and monitoring using grading levels . 3
4.1 General . 3
4.2 ISO-ACC descriptor format . 3
5 Demonstration of compliance with an ISO-ACC level . 5
5.1 Principle . 5
5.2 Testing . 5
5.3 Test report . 6
Annex A (informative) Parameters for consideration . 7
Annex B (informative) Typical contaminants .11
Annex C (informative) Typical methods of measurement .15
Annex D (informative) Consideration of specific requirements for separative devices .19
Bibliography .21
iii
ISO 14644-8:2022(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 third edition cancels and replaces the second edition (ISO 14644-8:2013), of which it constitutes a
minor revision. The changes are as follows:
— the term class (classification, classified) changed to grade or assessment where appropriate;
— 3.1.2, definition revised;
— Bibliography updated;
— 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 14644-8:2022(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination to levels of cleanliness appropriate for accomplishing process activities sensitive to a
range of contaminants. Products and processes that benefit from the control of airborne contamination
include those in such industries as aerospace, microelectronics, pharmaceuticals, medical devices,
food, healthcare, optics, instrumentation, vacuum technology, coatings, photovoltaics, displays, LEDs,
coatings, automotive and surface analysis.
In some of these industries, the product or process can be sensitive to, or can be destroyed by, chemical
contamination resulting from chemicals that are present due to external, process or other generated
sources.
Within this document, the presence of chemicals is expressed as air chemical contamination. Chemical
contamination is a three-step event. The first step is generation due to external sources such as
process leakage, construction material, personnel or material outgassing. The second step is transport
as airborne chemical contamination. The third step is sorption on the sensitive surface, which can be
quantified as a surface chemical contamination.
The generating materials and the surfaces where sorption takes place will have a large influence on
the steps of generation and sorption in addition to the actual air contamination. Thus, for these two
steps, not only the contaminants but als
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