SIST EN ISO 14644-8:2007
(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)
This part of ISO 14644 covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated cont rolled 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 . This part of ISO 14644 currently considers only concentrations of AMC between 100 and 10 12 g/m3 under cleanroom operation al conditions.
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
SIST EN ISO 14644-8:2007
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
SIST EN ISO 14644-8:2007 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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.
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EN ISO 14644-8:2006 (E)
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.
2
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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
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ISO 14644-8:2006(E)
PDF disclaimer
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shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 5 ----------------------
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 2006 – All rights reserved iii
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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
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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.
© ISO 2006 – All rights reserved v
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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
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ISO 14644-8:2006(E)
3.1.2
airborne molecular contamination
AMC
presence in the atmosphere of a cleanroom or controlled environment of molecular (chemical, non-particulate)
substances in the gaseous or vapour state that may have a deleterious effect on the product, process or
equipment in the cleanroom or controlled environment
NOTE This definition does not include macromolecules of biological origin that, which are judged to be particles.
3.1.3
surface molecular contamination
SMC
presence of molecular (chemical, non-particulate) substances in the sorbed state that may have a deleterious
effect on the product, or surface of interest, in the cleanroom or controlled environment
3.1.4
contaminant category
common name for a group of compounds with a specific and similar deleterious effect when deposited on the
surface of interest
3.1.5
outgassing
release of molecular substances in the gaseous or vapour state from a material
3.2 Contaminant categories
3.2.1
acid
substance whose chemical reaction characteristic is to establish new bonds by the acceptance of electron
pairs
3.2.2
base
substance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs
3.2.3
biotoxic
contaminant substance that is obnoxious to the development and preservation of the life of organisms,
microorganisms, tissues or individual cells
3.2.4
condensable
substance capable of depositing on a surface by condensation under cleanroom operating conditions
3.2.5
corrosive
substance that causes destructive chemical change of a surface
3.2.6
dopant
substance that, after sorption and/or diffusion, is incorporated in the bulk of a product and is capable of
changing the properties of materials, even in trace amounts
3.2.7
organic
substance based on carbon and also containing hydrogen, with or without oxygen, nitrogen or other elements
2 © ISO 2006 – All rights reserved
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ISO 14644-8:2006(E)
3.2.8
oxidant
substance that, upon deposition onto a surface or product of interest, results in the formation of an oxide
(O /O ) or participates in a redox reaction
2 3
4 Classification
4.1 General
Classification shall be specified by use of a classification descriptor as described in 4.2. This descriptor is
designated “ISO-AMC” and specifies the maximum total airborne molecular concentration permitted for a
contaminant category, an individual substances or a group of substances.
4.2 ISO-AMC descriptor format
The designation of AMC classification of a cleanroom or associated controlled environment shall be by means
of an ISO-AMC descriptor(s) appropriate for the contaminant category(ies), substances or group(s) of
substances under consideration.
The ISO-AMC descriptor is expressed in the format:
ISO-AMC Class N (X)
where
N is the ISO-AMC class, which is the logarithmic index of concentration, c , expressed in grams per
X
cubic metre, and falls within a limiting range of 0 to −12. Intermediate concentrations may be
specified, with 0,1 the smallest permitted increment of N;
N = log [c ];
10 X
and
X is a contaminant category (interaction with product) which includes, but is not limited to:
acid (ac);
base (ba);
biotoxic (bt);
condensable (cd);
corrosive (cr);
dopant (dp);
organic, total (or);
oxidant (ox);
or a group of substances or an individual substances.
−6 3
EXAMPLE 1 To express an airborne concentration of ammonia of 10 g/m, the designation is
“ISO-AMC Class −6 (NH )”.
3
© ISO 2006 – All rights reserved 3
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ISO 14644-8:2006(E)
−4 3
EXAMPLE 2 To express a total airborne concentration of organics, of 10 g/m, the designation is
“ISO-AMC Class −4 (or)”.
−8 3
EXAMPLE 3 To express a total airborne concentration of condensables of 5·10 g/m , the designation is
“ISO-AMC Class −7,3 (cd)”.
Table 1 and Figure 1 further illustrate the ISO-AMC classification as a function of contaminant concentration.
Table 1 — ISO-AMC classes
Concentration Concentration Concentration
ISO-AMC Class
3 3 3
g/m µg/m ng/m
0 6 9
0
10 10 (1 000 000) 10 (1 000 000 000)
−1 5 8
−1 10 10 (100 000) 10 (100 000 000)
−2 4 7
−2
10 10 (10 000) 10 (10 000 000)
−3 3 6
−3 10 10 (1 000) 10 (1 000 000)
−4 2 5
−4
10 10 (100) 10 (100 000)
−5 1 4
−5 10 10 (10) 10 (10 000)
−6 0 3
−6
10 10 (1) 10 (1 000)
−7 −1 2
−7 10 10 (0,1) 10 (100)
−8 −2 1
−8
10 10 (0,01) 10 (10)
−9 −3 0
−9 10 10 (0,001) 10 (1)
−10 −4 −1
−10
10 10 (0,000 1) 10 (0,1)
−11 −5 −2
−11 10 10 (0,000 01) 10 (0,01)
−12 −6 −3
−12
10 10 (0,000 001) 10 (0,001)
4 © ISO 2006 – All rights reserved
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ISO 14644-8:2006(E)
Key
3
X1 concentration (ng/m )
3
X2 concentration (g/m )
Y ISO-AMC class
Figure 1 — ISO-AMC classes as a function of concentration
5 Demonstration of compliance
5.1 Principle
Compliance with classification (ISO-AMC class) requirements specified by the customer is verified by
performing specified testing procedures agreed between the customer and supplier and by providing specified
documentation of the results and conditions of testing.
5.2 Testing
Example test methods are given in Annex C. The list of typical methods described is not exhaustive.
Alternative methods of comparable accuracy may be specified by agreement.
NOTE 1 Analysis by different methods, even when correctly applied, can produce different results of equal validity.
Tests performed to demonstrate compliance shall be conducted using suitable test methods and calibrated
instruments.
Sampling locations shall be determined by agreement between the customer and supplier.
© ISO 2006 – All rights reserved 5
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ISO 14644-8:2006(E)
It is recommended to carry out replicate sampling at the locations agreed.
NOTE 2 In analytical measurement, the contribution of particulate contamination cannot always be excluded.
The elapsed time period shall be agreed between the customer and supplier. See A.4.3.
5.3 Test report
The results from testing each cleanroom or associated controlled environment shall be recorded and
submitted as a comprehensive report, along with a statement of compliance or non-compliance with the
specified ISO-AMC class(es).
The test report shall include the following:
a) name of the test operator, the name and address of the testing organization and the date, time and
duration of sampling;
b) number and year of publication of this part of ISO 14644, i.e. ISO 14644-8:2006;
c) clear identification of the physical location of the cleanroom or controlled environment tested (including
reference to adjacent areas if necessary) and specific designations for coordinates of all sampling
locations;
d) specified designation criteria for the cleanroom or controlled environment, including the occupancy state,
the ISO-AMC class or classes, the specified test method(s) and, where applicable, the substances,
substance group or category(ies), the elapsed time period and the designated particulate class;
e) details of the test procedure used, with any available data describing the test circumstances or departures
from the test method, and identification of the test instrument(s) and its current calibration certificate(s);
f) test results, including airborne molecular concentration(s) data, for all
...
EUROPEAN STANDARD
DRAFT
prEN ISO 14644-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2004
ICS
English version
Cleanrooms and associated control environments - Part 8:
Classification of airborne molecular contamination
Salles propres et environnements maîtrisés apparentés -
Partie 8: Classification de la contamination moléculaire
aéroportée
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 243.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre 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, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 14644-8:2004: E
worldwide for CEN national Members.
---------------------- Page: 1 ----------------------
prEN ISO 14644-8:2004 (E)
Foreword
This document (prEN ISO 14644-8:2004) 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 document is currently submitted to the parallel Enquiry.
Endorsement notice
The text of ISO/DIS 14644-8:2004 has been approved by CEN as prEN ISO 14644-8:2004
without any modifications.
2
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DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-8
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2004-04-15 2004-09-15
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
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
ICS 13.040.35
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2004
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ISO/DIS 14644-8
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
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Reproduction may be subject to royalty payments or a licensing agreement.
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©
ii ISO 2004 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/DIS 14644-8
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-AMC 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
A.1 Principles. 7
A.2 Concepts for establishing parameters . 7
A.3 Outdoor air. 7
A.4 Construction materials. 8
A.5 Cross contamination. 8
A.6 Operation and maintenance. 8
A.7 Personnel. 9
A.8 Other sources. 9
Annex B (informative) Typical contaminants. 11
B.1 Principle. 11
Annex C (informative) Typical methods of measurement. 17
C.1 Principle. 17
C.2 Method concepts. 17
C.3 Typical sampling methods. 18
C.4 Typical analysis methods . 18
C.4.1 Off-line analysis methods . 18
C.4.2 On-line monitors. 19
C.5 Selection of typical sampling devices and analysis methods . 19
C.6 Test methods for AMC measurement – Reference documents . 19
Annex D (informative) Consideration of specific requirements for separative devices . 22
D.1 Principle. 22
D.2 Specific considerations. 22
Bibliography . 23
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ISO/DIS 14644-8
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: Terms and definitions
Part 7: Separative enclosures (clean air hoods, gloveboxes, isolators, minienvironments)
Part 8: Classification of airborne molecular contamination
Users should note that the titles listed for parts 3 and 5 to 8 are working titles at the time of the
release of part 8. In the event that one or more of these parts are deleted from the work programme,
the remaining parts may be renumbered.
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments —
Biocontamination control.
Annexes A to D of this part of ISO 14644 are for information only.
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ISO/DIS 14644-8
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 may be sensitive to 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 in air. 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 in air 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 International Standards prepared by ISO/TC 209. In some circumstances, relevant
regulatory agencies may impose supplementary policies or restrictions. In such situations appropriate
adaptations of this part of ISO 14644 may be required.
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DIS 14644-8:2003
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 species (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 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 species 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: Terms and definitions
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 (non-particulate) species that may have a deleterious effect on the product, process or
equipment
3.1.2
airborne molecular contamination (AMC)
presence in the atmosphere of a cleanroom or controlled environment of molecular (chemical, non-
particulate) species in the gaseous or vapour state that may have a deleterious effect on the product,
process or equipment in the cleanroom or controlled environment
NOTE This definition does not include biomolecules, which are judged to be particulates.
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ISO/DIS 14644-8
3.1.3
surface molecular contamination (SMC)
presence on the surface of a product or analytical instrument of molecular (chemical, non-particulate)
species in the sorbed state that may have a deleterious effect on the product, process or equipment in
the cleanroom or controlled environment
3.1.4
contaminant category
common name for a group of compounds with a specific and similar deleterious effect when deposited
on the surface of interest
3.1.5
outgassing
release of a molecular species in the gaseous or vapour state from a material
3.2 Contaminant categories
3.2.1
acid
species whose chemical reaction characteristic is to establish new bonds by the acceptance of
electron pairs
3.2.2
base
species whose chemical reaction characteristic is to establish new bonds by the donation of electron
pairs
3.2.3
biotoxic
contaminant species that is obnoxious to the development and preservation of the life of organisms,
micro-organisms, tissues or individual cells
3.2.4
condensable
species capable of depositing on a surface by condensation, under cleanroom operating conditions
3.2.5
corrosive
species that causes destructive chemical change of a surface
3.2.6
dopant
species that, after sorption, is incorporated in the bulk of a product and is capable of changing the
properties of materials, even in trace amounts
NOTE Typical examples of dopants are bulk modifiers in microelectronics and critical metal contaminants,
e.g. Na, Cu or Fe.
3.2.7
organic
species based on carbon and also containing hydrogen, with or without oxygen, nitrogen or other
elements
3.2.8
oxidant
species that, upon deposition to a product or surface of interest, results in the formation of an oxide
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ISO/DIS 14644-8
4 Classification
4.1 General
Classification shall be specified by use of a classification descriptor as described in 4.2. This
descriptor is designated 'ISO-AMC' and specifies the maximum total airborne molecular concentration
permitted for a contaminant category, an individual species or a group of species.
NOTE This part of ISO 14644 deals only with AMC as described in the Introduction. However, it has been
found useful to classify AMC according to its potential effect on a product as defined in 3.2.
4.2 ISO-AMC descriptor format
The designation of AMC classification of a cleanroom or associated controlled environment shall be
by means of an ISO-AMC descriptor(s) appropriate for the contaminant category(ies), species or
group(s) of species under consideration.
The ISO-AMC descriptor is expressed in the format:
ISO-AMC Class N (X)
where
3
N is the ISO-AMC class, which is the logarithmic index of concentration expressed in g/m
within a limiting range of 0 to -12. Intermediate concentrations may be specified, with 0,1 the
smallest permitted increment of N;
3
N = log [concentration in g/m ];
10
and
X is a contaminant category (interaction with product) expressed as:
acid (ac);
base (ba);
biotoxic (bt);
condensable (cd);
corrosive (cr);
dopant (dp);
organic, total (or);
oxidant (ox);
or a group of species or an individual species.
-6 3
EXAMPLE To express an airborne concentration of ammonia of 10 g/m , the designation would be: “ISO-
AMC Class -6 (NH )”
3
-4 3
EXAMPLE To express a total airborne concentration of organics, of 10 g/m , the designation would be:
“ISO-AMC Class -4 (or)”
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ISO/DIS 14644-8
-8 3
EXAMPLE To express a total airborne concentration of condensables of 5 · 10 g/m , the designation
would be: “ISO-AMC Class -7.3 (cd)”
Table 1 and Figure 1 further illustrate the ISO-AMC classification as a function of contaminant
concentration.
Table 1 — ISO-AMC classes
Concentration Concentration Concentration
ISO-AMC Class 3
g/m³ µg/m³ ng/m
0 6 9
0 10 10 (1,000,000) 10 (1,000,000,000)
-1 5 8
-1 10 10 (100,000) 10 (100.000,000)
-2 4 7
-2 10 10 (10,000) 10 (10,000,000)
-3 3 6
-3 10 10 (1,000) 10 (1,000,000)
-4 2 5
-4 10 10 (100) 10 (100,000)
-5 1 4
-5 10 10 (10) 10 (10,000)
-6 0 3
-6 10 10 (1) 10 (1,000)
-7 -1 2
-7 10 10 (0.1) 10 (100)
-8 -2 1
-8 10 10 (0.01) 10 (10)
-9 -3 0
-9 10 10 (0.001) 10 (1)
-10 -4 -1
-10 10 10 (0.0001) 10 (0.1)
-11 -5 -2
-11 10 10 (0.00001) 10 (0.01)
-12 -6 -3
-12 10 10 (0.000001) 10 (0.001)
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ISO/DIS 14644-8
Figure 1 — ISO-AMC classes as a function of concentration
5 Demonstration of compliance
5.1 Principle
Compliance with classification (ISO-AMC class) requirements specified by the customer is verified by
performing specified testing procedures agreed between the customer and supplier and by providing
specified documentation of the results and conditions of testing.
5.2 Testing
Example test methods are given in annex C. The list of typical methods described is not exhaustive.
Alternative methods of comparable accuracy may be specified by agreement.
NOTE 1 Analysis by different methods, even when correctly applied, may produce different results of equal
validity.
Tests performed to demonstrate compliance shall be conducted using suitable test methods and
calibrated instruments.
Sampling locations shall be determined by agreement between the customer and supplier.
NOTE 2 It is recommended to carry out replicate sampling at the locations agreed.
NOTE 3 In analytical measurement, the contribution of particulate contamination cannot always be excluded.
The elapsed time period shall be agreed between the customer and supplier. See A.4.3.
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ISO/DIS 14644-8
5.3 Test report
The results from testing each cleanroom or associated controlled environment shall be recorded and
submitted as a comprehensive report, along with a statement of compliance or non-compliance with
the specified ISO-AMC class(es).
The test report shall include the following:
a) name of the test operator, the name and address of the testing organisation and the date, time
and duration of sampling;
b) number and year of publication of this part of ISO 14644, i.e. ISO 14644-8:date of current issue;
c) clear identification of the physical location of the cleanroom or controlled environment tested
(including reference to adjacent areas if necessary), and specific designations for coordinates of
all sampling locations;
d) specified designation criteria for the cleanroom or controlled environment, including the
occupancy state, the ISO-AMC class or classes, the specified test method(s) and, where
applicable, the species, species group or category(ies), the elapsed time period and the
designated particulate class;
e) details of the test procedure used, with any available data describing the test circumstances or
departures from the test method, and identification of the test instrument(s) and its current
calibration certificate(s);
f) test results, including airborne molecular concentration(s) data, for all sampling locations.
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ISO/DIS 14644-8
Annex A
(informative)
Parameters for consideration
A.1 Principles
This annex is intended to give guidance to consideration of parameters affecting or contributing to
AMC within a cleanroom or associated controlled environment. Consideration of such parameters
needs to be developed at the initial stages of design and control requirements along with any special
considerations for operation of the facility.
A.2 Concepts for establishing parameters
1) First establish if the product or process is affected by molecular contamination, as in many
industries consideration of molecular contamination is not a governing factor.
2) Establish the contaminant categories that will affect the product or process and if any particular
species or species groups require special consideration.
3) Establish the maximum concentrations of contaminant categories and/or species or species
groups permitted for the product or process and designate the associated ISO-AMC descriptor in
accordance with 4.2.
4) Establish sources of molecular contamination and concentration levels that may occur from:
a) outdoor air (providing fresh air to the facility);
b) construction materials in the facility, especially those in contact with recirculating and
make-up air streams;
c) cross contamination that may occur within the facility;
d) operation and maintenance of the facility;
e) personnel, cleanroom apparel and auxiliary materials;
f) process media and tooling.
Further guidance on these occurrences is given in A.3 to A.8.
5) Establish the design requirements to avoid or reduce molecular contamination generated per A.2
4) to achieve the ISO-AMC class for the product or process.
A.3 Outdoor air
A.3.1 Where outdoor air is provided as fresh air to the facility to which the product or process is
exposed, the outdoor air quality and any seasonal variation should be established with regard to the
concentration of compounds or species affecting the product or process. In addition the construction
materials of heating, ventilation or air conditioning equipment, including cabling, should be taken into
account.
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ISO/DIS 14644-8
A.3.2 The analysis of concentration should be conducted over a period of time to establish its
variability, along with consideration of any future developments that may affect the outdoor air quality.
A.3.3 In some cases, due to prevailing winds, proximity of contaminating sources, etc., molecular
contamination concentrations may be minimised by selective positioning of the fresh air intake(s) to
the facility.
A.4 Construction materials
A.4.1 Construction materials serving the facility may be sources of molecular contamination
because of outgassing.
Examples of suitable cleanroom construction materials are given in annex E of ISO 14644-4:2001.
A.4.2 The degree of material outgassing can be dependent upon the temperature, relative humidity
and pressure of the clea
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