EN ISO 14644-2:2015
(Main)Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect airborne particle concentration.
ISO 14644-2:2015 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1 µm to 5 µm. Concentrations of ultrafine particles (particles smaller than 0,1µm) will be addressed in a separate standard.
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015)
Dieser Teil von ISO 14644 legt die Mindestanforderungen an einen Überwachungsplan für die Leistung eines Reinraums oder eines reinen Bereichs in Bezug auf die Luftreinheit anhand der Partikel¬konzentration auf der Grundlage von Parameter fest, die die Konzentration luftgetragener Partikel messen oder beeinflussen.
Dieser Teil von ISO 14644 behandelt nicht die Zustandsüberwachung von Aspekten, wie z. B. Vibration oder die allgemeine Instandhaltung der Engineeringsysteme. Er ist nicht für die Überwachung von Partikelgruppen vorgesehen, die außerhalb des festgelegten unteren Schwellenwerts (Nachweisgrenze) der Partikelgröße im Bereich zwischen 0,1 µm und 5 µm liegen. Konzen¬trationen von ultrafeinen Partikeln (Partikel kleiner als 0,1 µm) werden in ISO 14644 12:- 1) behandelt.
Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO 14644-2:2015)
ISO 14644-2:2015 spécifie les exigences minimales d'un plan de surveillance des performances d'une salle propre ou d'une zone propre en lien avec la propreté particulaire de l'air, d'après des paramètres qui mesurent ou modifient la concentration de particules en suspension dans l'air.
ISO 14644-2:2015 ne traite pas de la surveillance de l'état dans lequel se trouvent d'autres aspects tels que les vibrations ni de la maintenance générale des systèmes techniques. Elle ne traite pas de la surveillance des populations de particules dont le seuil inférieur se situe en dehors de l'étendue granulométrique de référence de 0,1 µm à 5 µm. Les concentrations de particules ultrafines (plus petites que 0,1 µm) seront traitées dans une norme séparée.
Čiste sobe in podobna nadzorovana okolja - 2. del: Nadzor za dokazovanje lastnosti čistih sob v povezavi s čistostjo zraka na osnovi koncentracije delcev (ISO 14644-2:2015)
Ta del standarda ISO 14644 določa minimalne zahteve za načrt nadzora lastnosti čiste sobe ali čistega območja v zvezi s čistostjo zraka na osnovi koncentracije delcev, ki temelji na parametrih za merjenje ali vplivanje na koncentracijo delcev v zraku.
Ta del standarda ISO 14644 ne obravnava nadzora stanja z vidika vibracij ali splošnega vzdrževanja inženirskih sistemov. Standard ne zajema nadzora populacij delcev, ki so zunaj določenega mejnega razpona velikosti delcev od 0,1 μm do 5 μm. Koncentracije ultra finih delcev (delcev, manjših od 0,1 μm) bodo obravnavane v ločenem standardu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2016
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SIST EN ISO 14644-2:2001
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Cleanrooms and associated controlled environments - Part 2: Monitoring to provide
evidence of cleanroom performance related to air cleanliness by particle concentration
(ISO 14644-2:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 2: Überwachung zum Nachweis der
Reinraumleistung bezüglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-
2:2015)
Salles propres et environnements maîtrisés apparentés - Partie 2: Surveillance du
maintien des performances de la salle propre pour la propreté particulaire de l'air (ISO
14644-2:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-2:2015
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.
EN ISO 14644-2
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-2:2000
English Version
Cleanrooms and associated controlled environments - Part
2: Monitoring to provide evidence of cleanroom
performance related to air cleanliness by particle
concentration (ISO 14644-2:2015)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 2:
- Partie 2: Surveillance du maintien des performances Überwachung zum Nachweis der Reinraumleistung
de la salle propre pour la propreté particulaire de l'air bezüglich Luftreinheit anhand der
(ISO 14644-2:2015) Partikelkonzentration (ISO 14644-2:2015)
This European Standard was approved by CEN on 27 November 2015.
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 CEN-CENELEC 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-2:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-2:2015) 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 June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 14644-2:2000.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-2:2015 has been approved by CEN as EN ISO 14644-2:2015 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-2
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 2:
Monitoring to provide evidence of
cleanroom performance related to air
cleanliness by particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 2: Surveillance du maintien des performances de la salle propre
pour la propreté particulaire de l’air
Reference number
ISO 14644-2:2015(E)
©
ISO 2015
ISO 14644-2:2015(E)
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2015 – All rights reserved
ISO 14644-2:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Creating, implementing and maintaining a monitoring plan . 2
4.1 Principle . 2
4.2 Risk assessment . 2
4.3 Monitoring plan . 3
4.4 Calibration . 3
4.5 Review and approval. 4
4.6 Response to a deviation during monitoring . 4
5 Periodic classification of air cleanliness by particle concentration .4
Annex A (informative) Matters to consider when developing a monitoring plan .5
Annex B (informative) Considerations for setting alert and action levels .9
Bibliography .14
ISO 14644-2:2015(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces the first edition (ISO 14644-2:2000), which has been
technically revised throughout.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
— Part 1: Classification of air cleanliness by particle concentration
— Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle
concentration
— 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 air cleanliness by chemical concentration (ACC)
— Part 9: Classification of surface cleanliness by particle concentration
— Part 10: Classification of surface cleanliness by chemical concentration
Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments — Bio-
contamination control:
— Part 1: General principles and methods
— Part 2: Evaluation and interpretation of bio-contamination data
iv © ISO 2015 – All rights reserved
ISO 14644-2:2015(E)
Introduction
This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to
the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with
ISO 14644-1:2015, 5.1. The monitoring activity provides a continuing flow of data over time, thereby
providing a more detailed view of the performance of the installation.
Potential benefits gained from monitoring are
— faster response to adverse events and conditions,
— ability to develop trends from data over time,
— integration of data from multiple instruments,
— enhanced knowledge of installation and process, which allows for more effective risk assessment, and
— improved control of operational costs and product losses.
ISO 14644-2 specifies the requirements of a monitoring plan, based on risk assessment of the intended
use. The data obtained provide evidence of cleanroom or clean zone performance related to air
cleanliness by particle concentration.
In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements
or restrictions. In such situations, appropriate adaptations of the monitoring procedures may be
required. After a monitoring plan is initially established and implemented, it may be necessary to
revise the plan when significant changes are made to the installation or process requirements. It is also
prudent to conduct periodic reviews of a monitoring plan based on data obtained and experience in use.
INTERNATIONAL STANDARD ISO 14644
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