EN ISO 14644-4:2001
(Main)Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-Inbetriebnahme (ISO 14644-4:2001)
Dieser Teil von ISO 14644 legt die Anforderungen für die Planung und die Ausführung von Reinraumanlagen (im Folgenden Reine Anlagen genannt) fest, schreibt jedoch keine spezifischen technischen oder vertraglichen Maßnahmen vor, um diese Anforderungen zu erreichen. Er ist für Auftraggeber, Lieferanten und Planer von Reinraumanlagen gedacht und beinhaltet eine Prüfliste mit wichtigen Leistungsanforderungen. Es wird eine Anleitung zur Ausführung einschließlich den Anforderungen für die Erst-Inbetriebnahme und Qualifizierung gegeben. Die grundlegenden Bestandteile von Planung und Ausführung, die zur Gewährleistung eines fortlaufenden und zufriedenstellenden Betriebs erforderlich sind, werden durch die Betrachtung der wesentlichen Aspekte von Betrieb und Instandhaltung identifiziert.
ANMERKUNG Weitere Hinweise im Hinblick auf die obengenannten Anforderungen sind in den Anhängen A bis H aufgeführt. Weitere Teile von ISO 14644 können ergänzende Informationen enthalten.
Die Anwendung dieses Teils von ISO 14644 ist wie folgt eingeschränkt:
Anwenderanforderungen werden durch den Auftraggeber oder Projektmanager vertreten.
Besondere Prozesse, die in einer Reinraumanlage untergebracht werden sollen, werden nicht festgelegt.
Brandschutz- und Sicherheitsmaßnahmen wurden nicht gesondert betrachtet; die nationalen und örtlich gegebenen Anforderungen sollten eingehalten werden.
Prozess- und Betriebsmedienanschlüsse werden nur hinsichtlich ihrer Trassenführung zwischen und in den verschiedenen Reinheitsbereichen betrachtet.
Bezüglich der Inbetriebnahme und Instandhaltung werden nur reinraumspezifische Anforderungen berücksichtigt.
Salles propres et environnements maîtrisés apparentés - Partie 4: Conception, construction et mise en fonctionnement (ISO 14644-4:2001)
La présente partie de l'ISO 14644 spécifie les exigences pour la conception et la construction d'installations de salles propres, mais elle ne prescrit nullement les moyens spécifiques technologiques ni contractuels permettant de satisfaire à ces exigences. Elle s'adresse aux acheteurs, fournisseurs et concepteurs des installations de salles propres et comprend une liste indicative de paramètres importants de performance. Des conseils en matière de construction sont proposés, accompagnés des exigences de mise en fonctionnement et de qualification. Les éléments de base de la conception et de la construction, nécessaires pour assurer le maintien d'un fonctionnement satisfaisant, sont identifiés par l'examen des aspects pertinents de l'exploitation et de la maintenance.
NOTE Des conseils complémentaires concernant les exigences ci-dessus sont fournis dans les annexes A à H. D'autres parties de l'ISO 14644 sont susceptibles de fournir des renseignements complémentaires. L'application de la présente partie de l'ISO 14644 est sujette aux limitations suivantes : - les exigences de l'utilisateur sont représentées par l'acheteur ou le prescripteur ; - des procédés spécifiques qu'hébergera l'installation de salle propre ne sont pas spécifiés ; - les règlements de sécurité et de protection incendie ne font pas l'objet d'un examen particulier; il convient de se conformer aux règlements nationaux ou locaux applicables; - on ne tient compte des fluides pour le procédé et des servitudes de raccordement et alimentations des systèmes que pour ce qui concerne le cheminement des réseaux entre, et à l'intérieur, des différentes zones de propreté ; - en ce qui concerne la mise en service et la maintenance, il n'est tenu compte que des exigences spécifiques aux salles propres.
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2002
Cleanrooms and associated controlled environments - Part 4: Design,
construction and start-up (ISO 14644-4:2001)
Cleanrooms and associated controlled environments - Part 4: Design, construction and
start-up (ISO 14644-4:2001)
Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-
Inbetriebnahme (ISO 14644-4:2001)
Salles propres et environnements maîtrisés apparentés - Partie 4: Conception,
construction et mise en fonctionnement (ISO 14644-4:2001)
Ta slovenski standard je istoveten z: EN ISO 14644-4:2001
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 14644-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2001
ICS 13.040.30
English version
Cleanrooms and associated controlled environments - Part 4:
Design, construction and start-up (ISO 14644-4:2001)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 4:
Partie 4: Conception, construction et mise en Planung, Ausführung und Erst-Inbetriebnahme (ISO 14644-
fonctionnement (ISO 14644-4:2001) 4:2001)
This European Standard was approved by CEN on 1 April 2001.
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 Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, 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
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-4:2001 E
worldwide for CEN national Members.
Page 2
CORRECTED 2003-03-26
Foreword
The text of the International Standard ISO 14644-4:2001 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 October 2001, and conflicting national
standards shall be withdrawn at the latest by October 2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 14644-4:2001 was approved by CEN as a
European Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).
Page 3
Annex ZA
(normative)
Normative references to international publications with their corresponding
European publications
This European Standard incorporates, by dated or undated reference, provisions from other
publications. These normativereferences are cited at the appropriate places in the text, and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified bycommon modifications, indicated by
(mod.), the relevant EN/HD applies.
Publication Year Title EN/HD Year
ISO 14644-1 1999 Cleanrooms and associated controlled EN ISO 14644-1 1999
environments — Part 1: Classification of air
cleanliness
ISO 14644-2 2000 Cleanrooms and associated controlled EN ISO 14644-2 2000
environments — Part 2: Specifications for
testing and monitoring to prove continued
compliance with ISO 14644-1
INTERNATIONAL ISO
STANDARD 14644-4
First edition
2001-04-01
Cleanrooms and associated controlled
environments —
Part 4:
Design, construction and start-up
Salles propres et environnements maîtrisés apparentés —
Partie 4: Conception, construction et mise en fonctionnement
Reference number
ISO 14644-4:2001(E)
©
ISO 2001
ISO 14644-4:2001(E)
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ii © ISO 2001 – All rights reserved
ISO 14644-4:2001(E)
Contents
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Requirements.3
5 Planning and design.4
5.1 Planning procedure .4
5.2 Design .5
6 Construction and start-up.5
7 Testing and approval.6
7.1 General.6
7.2 Construction approval .6
7.3 Functional approval.6
7.4 Operational approval.6
8 Documentation.6
8.1 General.6
8.2 Record of an installation.6
8.3 Operational instructions .6
8.4 Instructions for performance monitoring.7
8.5 Maintenance instructions .7
8.6 Maintenance record.7
8.7 Record of operation and maintenance training.8
Annex A (informative) Control and segregation concepts.9
Annex B (informative) Classification examples .16
Annex C (informative) Approval of an installation.19
Annex D (informative) Layout of an installation.23
Annex E (informative) Construction and materials.27
Annex F (informative) Environmental control of cleanrooms .32
Annex G (informative) Control of air cleanliness.35
Annex H (informative) Additional specification of requirements to be agreed upon between
purchaser/user and designer/supplier .37
Bibliography.50
ISO 14644-4:2001(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 14644-4 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: Vocabulary
� Part 7: Separative enclosures (clean air hoods, glove boxes, isolators, mini-environments)
Users should note that the titles listed for parts 3 and 5 to 7 are working titles at the time of the release of part 4. In
the event that one or more of these parts are deleted from the work programme, the remaining parts may be
renumbered.
Annexes A to H of this part of ISO 14644 are for information only.
iv © ISO 2001 – All rights reserved
ISO 14644-4:2001(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to
levels appropr
...
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