Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Change of target dates (TC Res 40/1997)

Reinräume und zugehörige Reinraumbereiche - Teil 2: Festlegungen zur Prüfung und Überwachung zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 (ISO 14644-2:2000)

Dieser Teil der Internationalen Norm ISO 14644 legt Anforderungen für die regelmäßige Prüfung eines Reinraumes oder Reinen Bereiches zum Nachweis seiner fortgesetzten Übereinstimmung mit ISO 14644-1 hinsichtlich der bezeichneten Klassifizierung der Partikelreinheit der Luft fest. Diese Anforderungen beziehen sich auf die in ISO 14644-1 beschriebene Prüfung zur Klassifizierung des Reinraumes oder des Reinen Bereiches. Darüber hinaus werden zusätzliche Prüfungen festgelegt, die aufgrund der Anforderungen dieser Internationalen Norm, durchzuführen sind. Fakultative Prüfungen werden ebenfalls aufgeführt.

Salles propres et environnements maîtrisés apparentés - Partie 2: Spécifications pour les essais et la surveillance en vue de démontrer le maintien de la conformité avec l'ISO 14644-1 (ISO 14644-2:2000)

La présente partie de l'ISO 14644 spécifie les exigences pour les essais périodiques d'une salle propre ou d'une zone propre en vue de démontrer le maintien de sa conformité avec l'ISO 14644-1, à la classe désignée de propreté particulaire de l'air. Ces exigences se réfèrent à l'essai décrit dans l'ISO 14644-1 pour la classification de la salle propre ou de la zone propre. Des essais complémentaires sont également spécifiés, selon les exigences de la présente partie de l'ISO 14644. Des essais complémentaires facultatifs, que l'utilisateur pourrait choisir de faire effectuer, sont également identifiés. La présente partie de l'ISO 14644 spécifie par ailleurs les exigences pour la surveillance (monitoring) d'une salle propre ou d'une zone propre (appelées ci-dessous indifféremment une installation), en vue de fournir la preuve du maintien de sa conformité avec l'ISO 14644-1 en matière de classification de la propreté particulaire de l'air.

Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000)

General Information

Status
Withdrawn
Publication Date
31-May-2001
Withdrawal Date
25-Jan-2016
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
26-Jan-2016
Due Date
18-Feb-2016
Completion Date
26-Jan-2016

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SLOVENSKI STANDARD
SIST EN ISO 14644-2:2001
01-junij-2001
Cleanrooms and associated controlled environments - Part 2: Specifications for
testing and monitoring to prove continued compliance with ISO 14644-1 (ISO
14644-2:2000)

Cleanrooms and associated controlled environments - Part 2: Specifications for testing

and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Festlegungen zur Prüfung und
Überwachung zum Nachweis der fortlaufenden Übereinstimmung mit ISO 14644-1 (ISO
14644-2:2000)

Salles propres et environnements maîtrisés apparentés - Partie 2: Spécifications pour les

essais et la surveillance en vue de démontrer le maintien de la conformité avec l'ISO

14644-1 (ISO 14644-2:2000)
Ta slovenski standard je istoveten z: EN ISO 14644-2:2000
ICS:
13.040.30 Kakovost zraka na delovnem Workplace atmospheres
mestu
SIST EN ISO 14644-2:2001 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-2:2001
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SIST EN ISO 14644-2:2001
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SIST EN ISO 14644-2:2001
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SIST EN ISO 14644-2:2001
INTERNATIONAL ISO
STANDARD 14644-2
First edition
2000-09-15
Cleanrooms and associated controlled
environments —
Part 2:
Specifications for testing and monitoring to
prove continued compliance with
ISO 14644-1
Salles propres et environnements maîtrisés apparentés —
Partie 2: Spécifications pour les essais et la surveilance en vue de
démontrer le maintien de la confirmité avec l'ISO 14644-1
Reference number
ISO 14644-2:2000(E)
ISO 2000
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SIST EN ISO 14644-2:2001
ISO 14644-2:2000(E)
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© ISO 2000

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ii © ISO 2000 – All rights reserved
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SIST EN ISO 14644-2:2001
ISO 14644-2:2000(E)
Contents Page

Foreword.....................................................................................................................................................................iv

Introduction.................................................................................................................................................................v

1 Scope ..............................................................................................................................................................1

2 Normative references ....................................................................................................................................1

3 Terms and definitions ...................................................................................................................................1

3.1 General terms.................................................................................................................................................1

3.2 Terms concerning frequency intervals .......................................................................................................2

4 Demonstration of continued compliance....................................................................................................2

4.1 Principle..........................................................................................................................................................2

4.2 Testing for continued compliance ...............................................................................................................2

4.3 Monitoring ......................................................................................................................................................4

4.4 Documentation...............................................................................................................................................4

4.5 Records...........................................................................................................................................................5

Annex A (informative) Optional tests ........................................................................................................................6

Annex B (informative) Guidance on the influence of risk assessment on cleanroom or clean zone tests

and monitoring...............................................................................................................................................7

© ISO 2000 – All rights reserved iii
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SIST EN ISO 14644-2:2001
ISO 14644-2:2000(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 3.

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 part of ISO 14644 may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

International Standard ISO 14644-2 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: Metrology and test methods
� Part 4: Design, construction and start-up
� Part 5: Operations
� Part 6: Terms and definitions

� Part 7: Separative enclosures (clean airhoods, gloveboxes, isolators, mini-environments)

Users should note that the titles listed for parts 3 to 7 are working titles at the time of the release of part 2. In the

event that one or more of these parts are deleted from the work programme, the remaining parts may be

renumbered.
Annexes A and B of this part of ISO 14644 are for information only.
iv © ISO 2000 – All rights reserved
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SIST EN ISO 14644-2:2001
ISO 14644-2:2000(E)
Introduction

This part of ISO 14644 provides a process to prove continued compliance with ISO 14644-1 and specifies minimum

requirements for testing and monitoring. In any testing plan, consideration should also be given to the particular

operational requirements, risk assessment of the installation, and its use.

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 aerospace, microelectronics, pharmaceuticals, medical devices,

healthcare, food and others. Many factors besides airborne particulate cleanliness should be considered in the

design, specification, operation and control of cleanrooms and other controlled environments.

In some circumstances, relevant regulatory agencies may impose supplementary policies or restrictions. In such

situations, appropriate adaptations of the standard testing procedures may be required.

© ISO 2000 – All rights reserved v
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SIST EN ISO 14644-2:2001
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SIST EN ISO 14644-2:2001
INTERNATIONAL STANDARD ISO 14644-2:2000(E)
Cleanrooms and associated controlled environments —
Part 2:
Specifications for testing and monitoring to prove continued
compliance with ISO 14644-1
1 Scope

This part of ISO 14644 specifies requirements for periodic testing of a cleanroom or clean zone to prove its

continued compliance with ISO 14644-1 for the designated classification of airborne particulate cleanliness.

These requirements invoke the test described in ISO 14644-1 for classification of a cleanroom or clean zone.

Additional tests are also specified, to be carried out in accordance with the requirements of this part of ISO 14644.

Optional tests, to be applied at the user’s discretion, are also identified.

This part of ISO 14644 also specifies requirements for monitoring of a cleanroom or clean zone (hereafter referred

to as an installation) to provide evidence of its continued compliance with ISO 14644-1 for the designated

classification of airborne particulate cleanliness.
2 Normative references

The following normative document contains provisions which, through reference in this text, constitute provisions of

this part of ISO 14644. For dated references, subsequent amendments to, or revisions of, any of these publications

do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the

possibilit
...

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