EN ISO 14644-8:2006
(Main)Cleanrooms and associated controlled environments - Part 8: Classification of airborne molecular contamination (ISO 14644-8:2006)
Cleanrooms and associated controlled environments - Part 8: Classification of airborne molecular contamination (ISO 14644-8:2006)
ISO 14644-8:2006 covers the classification of airborne molecular contamination (AMC) 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 14644-8:2006 currently considers only concentrations of AMC between 100 and 10?12 g/m3 under cleanroom operational conditions.
ISO 14644-8:2006 is not relevant for application in those industries, processes or production, where the presence of airborne molecular substances is not considered a risk to the product or process.
It is not the intention of ISO 14644-8:2006 to describe the nature of airborne molecular contaminants.
ISO 14644-8:2006 does not give a classification of surface molecular contamination.
Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifikation luftgetragener molekularer Kontamination (ISO 14644-8:2006)
Dieser Teil von ISO 14644 behandelt die Klassifizierung von luftgetragener molekularer Kontamination 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 Festlegung zur Klassifizierung einzuschließen.
Dieser Teil von ISO 14644 betrachtet ausschließlich Konzentrationen von luftgetragener molekularer Kontamination 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 einer Produktion, bei denen oder bei der das Vorhandensein von luftgetragenen molekularen Substanzen nicht als Risiko für das Produkt oder den Prozess betrachtet wird.
Es ist nicht Ziel dieses Teils von ISO 14644, die Natur luftgetragener molekularer Kontaminanten zu beschreiben.
Dieser Teil von ISO 14644 gibt keine Klassifizierung für molekulare Oberflächenkontamination vor.
Salles propres et environnements maîtrisés apparentés - Partie 8: Classification de la contamination moléculaire aéroportée (ISO 14644-8:2006)
L'ISO 14644-8:2006 traite de la classification de la contamination moléculaire aéroportée (AMC) dans les salles propres et les environnements maîtrisés apparentés, en termes de concentrations dans l'air 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 en vue d'une classification.
L'ISO 14644-8:2006 ne porte actuellement que sur les concentrations moléculaires aéroportées comprises entre 100 et 10-12 g/m3 dans les conditions d'exploitation des salles propres.
L'ISO 14644-8:2006 ne s'applique pas aux industries, procédés ou types de production où la présence de substances moléculaires aéroportées n'est pas considérée comme un risque pour le produit ou le procédé. Elle ne vise pas à décrire la nature des contaminants moléculaires aéroportés, ni ne fournit de classification de la contamination moléculaire surfacique.
Čiste sobe in podobna nadzorovana okolja - 8. del: Klasifikacija po zraku prenesene molekularne kontaminacije (ISO 14644-8:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2007
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO .ODVLILNDFLMDSR]UDNX
SUHQHVHQHPROHNXODUQHNRQWDPLQDFLMH ,62
Cleanrooms and associated controlled environments - Part 8: Classification of airborne
molecular contamination (ISO 14644-8:2006)
Reinräume und zugehörige Reinraumbereiche - Teil 8: Klassifikation luftgetragener
molekularer Kontamination (ISO 14644-8:2006)
Salles propres et environnements maîtrisés apparentés - Partie 8: Classification de la
contamination moléculaire aéroportée (ISO 14644-8:2006)
Ta slovenski standard je istoveten z: EN ISO 14644-8:2006
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
August 2006
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part 8:
Classification of airborne molecular contamination (ISO 14644-
8:2006)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 8:
Partie 8: Classification de la contamination moléculaire Klassifikation luftgetragener molekularer Kontamination
aéroportée (ISO 14644-8:2006) (ISO 14644-8:2006)
This European Standard was approved by CEN on 3 May 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-8:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 14644-8:2006) 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 2007, and conflicting national
standards shall be withdrawn at the latest by February 2007.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 14644-8:2006 has been approved by CEN as EN ISO 14644-8:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 14644-8
First edition
2006-08-15
Cleanrooms and associated controlled
environments —
Part 8:
Classification of airborne molecular
contamination
Salles propres et environnements maîtrisés apparentés —
Partie 8: Classification de la contamination moléculaire aéroportée
Reference number
ISO 14644-8:2006(E)
©
ISO 2006
ISO 14644-8:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 14644-8:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Classification. 3
5 Demonstration of compliance . 5
Annex A (informative) Parameters for consideration . 7
Annex B (informative) Typical contaminants . 10
Annex C (informative) Typical methods of measurement. 13
Annex D (informative) Consideration of specific requirements for separative devices . 17
Bibliography . 18
ISO 14644-8:2006(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 enclosures (clean air hoods, gloveboxes, isolators, mini-environments)
⎯ Part 8: Classification of airborne molecular contamination
iv © ISO 2006 – All rights reserved
ISO 14644-8:2006(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 and healthcare.
In some of these industries, the product or process can be sensitive to, or can be destroyed by, molecular
contamination resulting from airborne molecules that are present due to external, process, or otherwise
generated sources.
Within this part of ISO 14644, the presence of airborne molecules is expressed as airborne molecular
contamination (AMC). Molecular contamination is a three-step event. The first step is generation due to
external sources, process leakage or construction or human material outgassing. The second step is transport
as AMC. The third step is sorption on the sensitive surface, which can be quantified as a surface molecular
contamination (SMC).
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 AMC. Thus, for these two steps, not only the AMC 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, AMC has been chosen for the classification.
This part of ISO 14644 assigns ISO classification levels to be used to specify the limits of AMC concentrations
within a cleanroom and associated controlled environment, where the product or process is deemed to be at
risk from such contamination.
For classification purposes, this part of ISO 14644 is limited to a designated range of AMC concentrations and
provides standard protocols for specifying such concentrations with regard to chemical compounds, methods
of test and analysis, and time weighted factors.
Informative annexes are contained in this part of ISO 14644 covering
⎯ parameters for consideration: Annex A;
⎯ typical contaminating chemicals and substances: Annex B;
⎯ typical methods of measurement and analysis: Annex C;
⎯ considerations of specific requirements for separative enclosures: Annex D.
This part of ISO 14644 is one of a series of standards concerned with cleanrooms and contamination control.
Many factors besides AMC need to be considered in the design, specification, operation and control of
cleanrooms and other controlled environments. These are covered in some detail in other parts of the
[4]
International Standards prepared by ISO/TC 209. In particular, attention is drawn to ISO 14698 (all parts) . In
some circumstances, relevant regulatory agencies can impose supplementary policies or restrictions. In such
situations, appropriate adaptations of this part of ISO 14644 may be required.
INTERNATIONAL STANDARD ISO 14644-8:2006(E)
Cleanrooms and associated controlled environments —
Part 8:
Classification of airborne molecular contamination
1 Scope
This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) 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.
0 −12 3
This part of ISO 14644 currently considers only concentrations of AMC between 10 and 10 g/m under
cleanroom operational conditions.
This part of ISO 14644 is not relevant for application in those industries, processes or production, where the
presence of airborne molecular substances is not considered a risk to the product or process.
It is not the intention of this part of ISO 14644 to describe the nature of airborne molecular contaminants.
This part of ISO 14644 does not give a classification of surface molecular contamination.
2 Normative references
The following referenced documents are indispensable for the application 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 14644-6, Cleanrooms and associated controlled environments — Part 6: Vocabulary
3 Terms and definitions
For the purposes of this part of ISO 14644, the terms and definitions given in ISO 14644-6 and the following
apply.
3.1 General
3.1.1
molecular contamination
molecular (chemical, non-particulate) substances that can have a deleterious effect on the product, process or
equipment
ISO 14644-8:2006(E)
3.1.2
...
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