Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)

ISO 14644-8:2013 establishes the classification 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 within the specification for classification.
ISO 14644-8:2013 currently considers only concentrations of air chemical contaminants between 100 and 10−12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2013 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 ISO 14644-8:2013 to describe the nature of air chemical contaminants.
ISO 14644-8:2013 does not give a classification of surface chemical contamination.

Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifizierung der Luftreinheit anhand der Chemikalienkonzentration (ACC) (ISO 14644-8:2013)

Dieser Teil von ISO 14644 beschreibt die Klassifizierung der chemischen Luftreinheit in Reinräumen und zugehörigen Reinraumbereichen hinsichtlich der luftgetragenen Konzentrationen spezifischer chemischer Substanzen (einzeln, gruppenweise oder als Kategorien) und stellt ein Protokoll zur Verfügung, um Prüf-verfahren, Analyse und Zeitgewichtungsfaktoren in die Festlegung zur Klassifizierung einzuschließen.
Dieser Teil von ISO 14644 betrachtet ausschließlich Konzentrationen von luftgetragenen chemischen Kontaminanten im Bereich von 100 g/m3 und 10-12 g/m3 unter Reinraumbetriebsbedingungen.
Dieser Teil von ISO 14644 ist nicht anwendbar bei solchen Industriezweigen und 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 Teils von ISO 14644, die Beschaffenheit luftgetragener chemischer Kontaminanten zu beschreiben.
Dieser Teil von ISO 14644 gibt keine Klassifizierung für chemische Oberflächenkontamination vor.

Salles propres et environnements maîtrisés apparentés - Partie 8: Classification de la propreté chimique de l'air (ISO 14644-8:2013)

L'ISO 14644-8:2013 établit la classification 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 (individu, groupe ou catégorie), et fournit un protocole permettant d'intégrer les méthodes d'essai, l'analyse et les facteurs de pondération dans le temps dans la spécification destinée à la classification.
L'ISO 14644-8:2013 ne porte actuellement que sur les concentrations de contaminants chimiques dans l'air comprises entre 100 et 10−12 g/m3 dans les conditions d'exploitation des salles propres.
L'ISO 14644-8:2013 ne s'applique pas aux secteurs industriels, aux procédés ou aux types de production où la présence de substances chimiques aéroportées n'est pas considérée comme un risque pour le produit ou le procédé.
L'ISO 14644-8:2013 ne vise pas à décrire la nature des contaminants chimiques dans l'air.
L'ISO 14644-8:2013 ne fournit pas de classification de la contamination chimique surfacique.

Čiste sobe in podobna nadzorovana okolja - 8. del: Klasifikacija čistosti zraka na osnovi koncentracije onesnaževal v zraku (ACC) (ISO 14644-8:2013)

Ta del standarda ISO 14644 zajema klasifikacijo kemijske čistosti zraka (ACC) v čistih sobah in podobnih nadzorovanih okoljih v smislu koncentracij različnih kemijskih snovi v zraku (posameznih, skupin ali vrst) in določa protokol za vključitev preskusnih metod, analiz in časovno prilagojenih faktorjev v specifikacije za klasifikacijo. Ta del standarda ISO 14644 trenutno obravnava samo kemijske onesnaževalce zraka v koncentraciji med 100 in 10-12 g/m3 v obratovalnih pogojih čiste sobe. Ta del standarda ISO 14644 se ne uporablja za industrije, procese in proizvodnje, kjer se prisotnost kemijskih substanc v zraku ne šteje za nevarno proizvodu ali procesu. Ta del standarda ISO 14644 ni namenjen opisovanju lastnosti kemijskih onesnaževalcev zraka. Ta del standarda ISO 14644 ne vsebuje klasifikacije kemijske onesnaženosti površja.

General Information

Status
Withdrawn
Publication Date
19-Feb-2013
Withdrawal Date
05-Jul-2022
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
06-Jul-2022

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Cleanrooms and associated controlled environments - Part 8: Classification of air
cleanliness by chemical concentration (ACC) (ISO 14644-8:2013)
Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifizierung der Luftreinheit
anhand der Chemikalienkonzentration (ACC) (ISO 14644-8:2013)
Salles propres et environnements maîtrisés apparentés - Partie 8: Classification de la
propreté chimique de l'air (ISO 14644-8:2013)
Ta slovenski standard je istoveten z: EN ISO 14644-8:2013
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.

EUROPEAN STANDARD
EN ISO 14644-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2013
ICS 13.040.35 Supersedes EN ISO 14644-8:2006
English Version
Cleanrooms and associated controlled environments - Part 8:
Classification of air cleanliness by chemical concentration (ACC)
(ISO 14644-8:2013)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 8:
Partie 8: Classification de la propreté chimique de l'air (ISO Klassifizierung der Luftreinheit anhand der
14644-8:2013) Chemikalienkonzentration (ACC) (ISO 14644-8:2013)
This European Standard was approved by CEN on 9 February 2013.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-8:2013: E
worldwide for CEN national Members.

Contents Page
Foreword . 3
Foreword
This document (EN ISO 14644-8:2013) 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 August 2013, and conflicting national standards shall be withdrawn at
the latest by August 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14644-8:2006.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-8:2013 has been approved by CEN as EN ISO 14644-8:2013 without any modification.

INTERNATIONAL ISO
STANDARD 14644-8
Second edition
2013-02-15
Cleanrooms and associated controlled
environments —
Part 8:
Classification of air cleanliness by
chemical concentration (ACC)
Salles propres et environnements maîtrisés apparentés —
Partie 8: Classification de la propreté chimique de l’air
Reference number
ISO 14644-8:2013(E)
©
ISO 2013
ISO 14644-8:2013(E)
© ISO 2013
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO 14644-8:2013(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 Classification . 3
4.1 General . 3
4.2 ISO-ACC descriptor format . 3
5 Demonstration of compliance . 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
ISO 14644-8:2013(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
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.
ISO 14644-8 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
— Part 1: Classification of air cleanliness
— Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644‑1
— Part 3: Test methods
— Part 4: Design, construction and start‑up
— Part 5: Operations
— Part 6: Vocabulary
— Part 7: Separative devices (clean air hoods, gloveboxes, isolators, mini‑environments)
— Part 8: Classification of air cleanliness by chemical concentration (ACC)
— Part 9: Classification of surface cleanliness by particle concentration
— Part 10: Classification of surface cleanliness by chemical concentration
This second edition cancels and replaces the first edition (ISO 14644-8:2006), which has been
technically revised.
iv © ISO 2013 – All rights reserved

ISO 14644-8:2013(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination to levels appropriate for accomplishing contamination-sensitive activities. 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 otherwise
generated sources.
Within this part of ISO 14644, 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 or construction material or 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 also the involved bulk and surfaces need to be defined. In order to
make a standard generally applicable to any type of cleanroom or associated controlled environment,
air chemical cleanliness (ACC) has been chosen for the classification.
This part of ISO 14644 assigns ISO classification levels to be used to specify the level of ACC within a
cleanroom and associated controlled environment, where the product or process is deemed to be at risk
from air chemical contamination.
For classification purposes, this part of ISO 14644 is limited to a designated range of ACC and provides
standard protocols for specifying such levels with regard to chemical compounds, methods of test and
analysis, and time weighted factors.
Informative annexes
...

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