EN ISO 14644-1:2015

Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)

ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644‑7.
Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 µm to 5 µm are considered for classification purposes.
The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.
ISO 14644-1:2015 does not provide for classification 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 0,1 µm) will be addressed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 µm).
ISO 14644-1:2015 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.

Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit anhand der Partikelkonzentration (ISO 14644-1:2015)

Dieser Teil der ISO 14644 enthält die Klassifizierung der Luftreinheit in Reinräumen und zugehörigen Rein¬raumbereichen sowie von SD-Modulen (en: separative device, SD) nach ISO 14644 7 anhand der Konzentration luftgetragener Partikel.
Für Klassifizierungszwecke werden nur Partikelgruppen in Betracht gezogen, deren Summenhäufigkeits-verteilung auf dem Schwellenwert der Partikelgröße (untere (Nachweis-)Grenze) beruht, der von 0,1 µm bis 5 µm reicht.
Die Anwendung von Streulicht-Einzelpartikelzählern (LSAPC, en. light scattering (discrete) airborne particle counter) ist die Grundlage für die Bestimmung der Konzentration luftgetragener Partikel gleich und größer dem festgelegten Größenbereich an gekennzeichneten Probenahmeorten.
Dieser Teil der ISO 14644 trifft nicht auf die Klassifizierung von Partikelgruppen zu, die außerhalb des fest-gelegten unteren Schwellenwerts (Nachweisgrenze) der Partikelgröße im Bereich zwischen 0,1 µm und 5 µm liegen. Konzentrationen von ultrafeinen Partikeln (nanoskalige Partikel kleiner als 0,1 µm) werden in einem anderen Teil der Normenreihe behandelt, der die Luftreinheit anhand der Partikelkonzentration luftgetragener Nano¬partikel festlegt, während ein M-Deskriptor (siehe Anhang C) zur Quantifizierung von Makropartikelgruppen (Partikel größer als 5 µm) angewendet werden darf.
Dieser Teil der ISO 14644 eignet sich nicht zur Charakterisierung der physikalischen, chemischen, radiologischen sowie der lebensfähigen (aktiven) oder der anderen Arten von luftgetragenen Partikeln.

Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la propreté particulaire de l'air (ISO 14644-1:2015)

ISO 14644-1:2015 spécifie la classification de la propreté de l'air des salles propres, des zones propres et des dispositifs séparatifs tels que définis dans l'ISO 14644‑7 en termes de concentration des particules en suspension dans l'air.
Seules sont prises en compte les populations de particules présentant une distribution granulométrique cumulée dont le seuil inférieur se situe dans l'étendue de 0,1 µm à 5 µm.
La méthode de référence pour déterminer la concentration de particules dans l'air d'une taille supérieure ou égale aux tailles spécifiées aux points de prélèvement désignés est l'utilisation de compteurs utilisant les propriétés de diffusion de la lumière (light scattering airborne particle counters - LSAPC).
La présente partie de l'ISO 14644 ne donne pas de classification pour 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 laquelle spécifiera la propreté particulaire de l'air à l'échelle nanométrique. Un descripteur M (voir l'Annexe C) pouvant être utilisé pour quantifier les populations de macroparticules (particules plus grandes que 5 µm).
ISO 14644-1:2015 ne peut pas être utilisée pour caractériser la nature physique, chimique, radiologique ou viable des particules en suspension dans l'air.

Čiste sobe in podobna nadzorovana okolja - 1. del: Klasifikacija čistosti zraka na osnovi koncentracije delcev (ISO 14644-1:2015)

Ta del evropskega standarda določa klasifikacijo čistosti na osnovi koncentracije delcev v čistih sobah in prostorih z nadzorom čistega zraka v treh možnih stanjih glede na količino delcev, prisotnih v zraku.

General Information

• Status: Published
• Publication Date: 22-Dec-2015
• Withdrawal Date: 29-Jun-2016
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 23-Dec-2015
• Completion Date: 23-Dec-2015
• Ref Project: SIST EN ISO 14644-1:2016 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)

Relations

• Replaces: EN ISO 14644-1:1999 - Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999)
• Effective Date: 30-Dec-2015

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST EN ISO 14644-1:2000
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO.ODVLILNDFLMDþLVWRVWL]UDNDQD
RVQRYLNRQFHQWUDFLMHGHOFHY,62
Cleanrooms and associated controlled environments - Part 1: Classification of air
cleanliness by particle concentration (ISO 14644-1:2015)
Reinräume und zugehörige Reinraumbereiche - Teil 1: Klassifizierung der Luftreinheit
anhand der Partikelkonzentration (ISO 14644-1:2015)
Salles propres et environnements maîtrisés apparentés - Partie 1: Classification de la
propreté particulaire de l'air (ISO 14644-1:2015)
Ta slovenski standard je istoveten z: EN ISO 14644-1:2015
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 14644-1
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-1:1999
English Version
Cleanrooms and associated controlled environments - Part
1: Classification of air cleanliness by particle concentration
(ISO 14644-1:2015)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 1:
- Partie 1: Classification de la propreté particulaire de Klassifizierung der Luftreinheit anhand der
l'air (ISO 14644-1:2015) Partikelkonzentration (ISO 14644-1:2015)
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 14644-1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-1:2015) 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 14644-1:1999.
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 14644-1:2015 has been approved by CEN as EN ISO 14644-1:2015 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-1
Second edition
2015-12-15
Cleanrooms and associated controlled
environments —
Part 1:
Classification of air cleanliness by
particle concentration
Salles propres et environnements maîtrisés apparentés —
Partie 1: Classification de la propreté particulaire de l’air
Reference number
ISO 14644-1:2015(E)
©
ISO 2015
ISO 14644-1:2015(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
the requester.
ISO copyright office
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Tel. [phone]
Fax [phone]
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www.iso.org
ii © ISO 2015 – All rights reserved

ISO 14644-1:2015(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Airborne particles . 2
3.3 Occupancy states . 3
3.4 Testing instrumentation (see Annex F) . 3
3.5 Instrument specifications . 4
4 Classification . 4
4.1 Occupancy state(s) . 4
4.2 Particle size(s) . 4
4.3 ISO Class number . 4
4.4 Designation . 5
4.5 Intermediate decimal cleanliness classes and particle size thresholds . 5
5 Demonstration of compliance . 6
5.1 Principle . 6
5.2 Testing . 6
5.3 Airborne particle concentration evaluation . 6
5.4 Test report . 6
Annex A (normative) Reference method for classification of air cleanliness by
particle concentration . 8
Annex B (informative) Examples of classification calculations .13
Annex C (informative) Counting and sizing of airborne macroparticles .22
Annex D (informative) Sequential sampling procedure .27
Annex E (informative) Specification of intermediate decimal cleanliness classes and
particle size thresholds .34
Annex F (informative) Test instruments .36
Bibliography .37
ISO 14644-1:2015(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 14644-1:1999), 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: Classifica
...