EN ISO 14644-5:2004

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)

Dieser Teil von ISO 14644 legt grundlegende Anforderungen an den Betrieb von Reinräumen fest. Er richtet sich an alle, die die Nutzung und den Betrieb eines Reinraums planen. Sicherheitsaspekte, die keinen direkten Bezug zur Kontaminationskontrolle haben, werden in diesem Teil von ISO 14644 nicht berücksichtigt. Landesspezifische und örtliche Sicherheitsbestimmungen sind ebenso einzuhalten. Diese Norm behandelt  alle Klassen von Reinräumen, die zur Herstellung der verschiedensten Produkte eingesetzt werden. Dieses Dokument ist daher auf eine breite Anwendung ausgelegt und geht daher auf besondere Anforderungen für einzelne Industriezweige nicht ein. Verfahren und Programme zur laufenden Überwachung im Reinraum werden in diesem Teil von ISO 14644 nicht im Einzelnen behandelt; hinsichtlich der Überwachung von Partikeln wird auf ISO 14644-2 und ISO 14644-3 und hinsichtlich der Überwachung von Mikroorganismen auf ISO 14698-1 und ISO 14698-2 verwiesen.

Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO 14644-5:2004)

L'ISO 14644-5:2004 spécifie les exigences de base pour l'exploitation des salles propres. Elle s'adresse aux personnes qui envisagent d'utiliser et d'exploiter une salle propre. Les aspects de sécurité qui ne concernent pas directement la maîtrise de la contamination ne sont pas pris en compte dans l'ISO 14644-5:2004. Les réglementations nationales ou locales en matière de sécurité doivent être respectées. Le présent document s'applique à toutes les classes de salles propres utilisées pour la production de tous les types de produits. Le présent document a donc un vaste domaine d'application et n'aborde pas les exigences particulières de telle ou telle industrie en particulier. Les méthodes et les programmes de surveillance régulière dans les salles propres ne sont pas abordés de manière détaillée dans l'ISO 14644-5:2004. Il convient cependant de se référer à l'ISO 14644-2 et à l'ISO 14644-3 pour la surveillance des particules, ainsi qu'à l'ISO 14698-1 et à l'ISO 14698-2 pour la surveillance des micro-organismes.

Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2004)

General Information

• Status: Published
• Publication Date: 14-Aug-2004
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 31-Jul-2009
• Completion Date: 31-Jul-2009
• Ref Project: SIST EN ISO 14644-5:2005 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)

Relations

• Revised: prEN ISO 14644-5 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS 14644-5:2024)
• Effective Date: 13-Dec-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2005
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMD±GHO'HORYDQMH,62
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-
5:2004)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2004)
Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO
14644-5:2004)
Ta slovenski standard je istoveten z: EN ISO 14644-5:2004
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 14644-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2004
ICS
English version
Cleanrooms and associated controlled environments - Part 5:
Operations (ISO 14644-5:2004)
Salles propres et environnements maîtrisés apparentés - Reinräume und zugehörige Reinraumbereiche - Teil 5:
Partie 5: Exploitation (ISO 14644-5:2004) Betrieb (ISO 14644-5:2004)
This European Standard was approved by CEN on 29 July 2004.
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, 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
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-5:2004: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 14644-5:2004) 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 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 2005, and conflicting national
standards shall be withdrawn at the latest by February 2005.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 14644-5:2004 has been approved by CEN as EN ISO 14644-5:2004 without any
modifications.
INTERNATIONAL ISO
STANDARD 14644-5
First edition
2004-08-15
Cleanrooms and associated controlled
environments —
Part 5:
Operations
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
Reference number
ISO 14644-5:2004(E)
©
ISO 2004
ISO 14644-5:2004(E)
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ii © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Specification of requirements . 3
Annex A (informative) Operational systems. 7
Annex B (informative) Cleanroom clothing. 13
Annex C (informative) Personnel . 18
Annex D (informative) Stationary equipment. 22
Annex E (informative) Materials and portable equipment . 26
Annex F (informative) Cleanroom cleaning . 33
Bibliography . 43

ISO 14644-5:2004(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 14644-5 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 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
 Part 8: Classification of airborne molecular contamination
The following part is under preparation:
 Part 6: Terms and definitions

iv © ISO 2004 – All rights reserved

ISO 14644-5:2004(E)
Introduction
Industries and organizations of all kinds utilize cleanrooms. Operational procedures have a profound effect on
the cleanliness levels achieved during the operation of the cleanroom and equipment. Consistent quality is
cleanliness dependent. Operational cleanliness can only be attained and maintained through a deliberate
programme established to specify, measure and enforce defined operational procedures. Regulatory agencies
that have authority over processes and products produced in the cleanroom may require additional
procedures and measures of cleanliness not covered in this general operating standard.
This part of ISO 14644 addresses normative and informative operational requirements related to:
a) providing a system that defines policies and operational procedures;
b) clothing used to isolate human-generated contamination from the cleanroom environment;
c) training of personnel inside the cleanroom and monitoring their compliance to specified procedures and
disciplines;
d) transfer, installation and maintenance of stationary equipment (selection criteria is not discussed);
e) selection and use of materials and portable equipment in the cleanroom;
f) maintaining the cleanliness of the cleanroom through systematic cleaning and monitoring procedures.

INTERNATIONAL STANDARD ISO 14644-5:2004(E)

Cleanrooms and associated controlled environments —
Part 5:
Operations
1 Scope
This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning
to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are
not considered in this part of ISO 14644 and national and local safety regulations must be observed. This
document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in
application and does not address specific requirements for individual industries. Methods and programmes for
routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference is made
to ISO 14644-2 and ISO 14644-3 for monitoring particles and ISO 14698-1 and ISO 14698-2 for monitoring
micro-organisms.
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 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 14644-2:2000, Cleanrooms and associated controlled environments — Part 2: Specifications for testing
and monitoring to prove continued compliance with ISO 14644-1
1)
ISO 14644-3:— , Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14698-1:2003, Cleanrooms and associated controlled environments — Biocontamination control —
Part 1: General principles and methods
ISO 14698-2:2003, Cleanrooms and associated controlled environments — Biocontamination control —
Part 2: Evaluation and interpretation of biocontamination data

1) To be published.
ISO 14644-5:2004(E)
3 Terms and definitions
For the purposes of this part of ISO 14644, the following terms and definitions apply.
3.1 General Terms
3.1.1
biocleanroom
cleanroom used for products and processes that are sensitive to microbiological contamination
3.1.2
changing room
room where people entering or leaving a cleanroom put on or take off cleanroom clothing
NOTE Adapted from ISO 14644-4:2001, 3.1.
3.1.3
cross-over bench
bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of
floor contamination
3.1.4
disinfection
removal, destruction or de-activation of micro-organisms on objects or surfaces
3.1.5
fibre
particle having an aspect (length-to-width) ratio of 10 or more
[ISO 14644-1:1999, 2.2.7]
3.1.6
operator
person working in the cleanroom performing production work or carrying out process procedures
3.1.7
particle
minute piece of matter with defined physical boundaries
NOTE For classification purposes refer to ISO 14644-1:1999.
3.1.8
personnel
persons entering the cleanroom for any purpose
3.1.9
separative device
equipment utilizing constructional and dynamic means to create assured
...