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

Status
Withdrawn
Publication Date
14-Aug-2006
Withdrawal Date
19-Feb-2013
Current Stage
9960 - Withdrawal effective - Withdrawal
Due Date
20-Feb-2013
Completion Date
20-Feb-2013

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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.

---------------------- Page: 1 ----------------------
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.
---------------------- Page: 2 ----------------------
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.
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
ISO 14644-8:2006(E)
PDF disclaimer

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© 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
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
---------------------- Page: 8 ----------------------
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 2006 – All rights reserved 1
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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
---------------------- Page: 10 ----------------------
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

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 )”.
© 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
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
10 10 (10 000) 10 (10 000 000)
−3 3 6
−3 10 10 (1 000) 10 (1 000 000)
−4 2 5
10 10 (100) 10 (100 000)
−5 1 4
−5 10 10 (10) 10 (10 000)
−6 0 3
10 10 (1) 10 (1 000)
−7 −1 2
−7 10 10 (0,1) 10 (100)
−8 −2 1
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
X1 concentration (ng/m )
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
...

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