EN ISO 14644-15:2017

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8).
The following are outside the scope of ISO 14644-15:2017:
-      health and safety requirements;
-      compatibility with cleaning agents and techniques;
-      cleanability;
-      biocontamination;
-      specific requirements of equipment and materials for processes and products;
-      design details of equipment.

Reinräume und zugehörige Reinraumbereiche — Teil 15: Bewertung der Reinraumtauglichkeit von Ausrüstungsgegenständen und Materialien anhand der chemischen Luft- und Oberflächenkonzentration (ISO 14644-15:2017)

Dieses Dokument enthält Anforderungen und Richtlinien zur Bewertung der chemischen luftgetragenen Reinheit von Ausrüstung und Materialien, die für den Gebrauch in Reinräumen und hiermit verbundenen kontrollierten Bereichen vorgesehen sind, die mit der ISO-Norm für Reinheitsklassen anhand der chemischen Konzentration (siehe ISO 14644 8) zusammenhängen.
Gesundheits- und Sicherheitsanforderungen werden von diesem Dokument nicht abgedeckt und könnte von rechtlichen Dokumenten des spezifischen Landes abgedeckt sein.
Folgende Themen sind ausgeschlossen.
—   Kompatibilität mit Reinigungsmitteln und -techniken;
—   Reinigungsfähigkeit;
—   Biokontamination;
—   bestimmte Anforderungen an Ausrüstung und Materialien für Prozesse und Produkte;
—   Konstruktionsdetails der Ausrüstung

Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de l'aptitude à l'emploi des équipements et des matériaux par la détermination de la concentration chimique aéroportée (ISO 14644-15:2017)

L'ISO 146444-15 :2017 fournit des exigences et des lignes directrices relatives à l'évaluation de la propreté chimique de l'air d'équipements et de matériaux destinés à être utilisés dans des salles propres et des environnements maîtrisés apparentés. Ces exigences et lignes directrices sont liées à la norme ISO relative aux classes de propreté chimique (voir l'ISO 14644‑8).
Les aspects suivants ne font pas partie du domaine d'application:
-      exigences de santé et de sécurité;
-      compatibilité avec les agents et les techniques de nettoyage;
-      nettoyabilité;
-      biocontamination;
-      exigences spécifiques applicables aux équipements et matériaux en ce qui concerne des procédés et des produits;
-      détails de la conception des équipements.

Čiste sobe in podobna nadzorovana okolja - 15. del: Ocena ustreznosti uporabe opreme in materialov na osnovi koncentracije onesnaževal v zraku (ISO 14644-15:2017)

Ta dokument določa zahteve in smernice za ocenjevanje čistoče
opreme in materialov na osnovi koncentracije onesnaževal v zraku za uporabo v čistih sobah in podobnih nadzorovanih
okoljih, ki so povezani s standardom ISO za razrede čistosti zraka na osnovi koncentracije onesnaževal v zraku
(glej ISO 14644-8).
Naslednje ne spada na področje uporabe tega dokumenta:
– zdravstvene in varnostne zahteve;
– združljivost s čistilnimi sredstvi in tehnikami;
– možnost čiščenja;
– biokontaminacija;
– posebne zahteve za opremo in materiale za postopke in proizvode;
– zasnovne podrobnosti opreme.

General Information

• Status: Published
• Publication Date: 05-Dec-2017
• Withdrawal Date: 29-Jun-2018
• 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: 06-Dec-2017
• Completion Date: 06-Dec-2017
• Ref Project: SIST EN ISO 14644-15:2018 - Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2018
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQDXVWUH]QRVWLXSRUDEH
RSUHPHLQPDWHULDORYQDRVQRYLNRQFHQWUDFLMHRQHVQDåHYDOY]UDNX,62

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability
for use of equipment and materials by airborne chemical concentration (ISO 14644-
15:2017)
Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der
Reinraumtauglichkeit von Geräten und Materialien anhand der chemischen Luft- und
Oberflächenkonzentration (ISO 14644-15:2017)
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de
l'aptitude à l'emploi des équipements et des matériaux par la détermination de la
concentration chimique aéroportée (ISO 14644-15:2017)
Ta slovenski standard je istoveten z: EN ISO 14644-15:2017
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 14644-15
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2017
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
15: Assessment of suitability for use of equipment and
materials by airborne chemical concentration (ISO 14644-
15:2017)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 15: Évaluation de l'aptitude à l'emploi des 15: Bewertung der Reinraumtauglichkeit von Geräten
équipements et des matériaux par la détermination de und Materialien anhand der chemischen Luft- und
la concentration chimique aéroportée (ISO 14644- Oberflächenkonzentration (ISO 14644-15:2017)
15:2017)
This European Standard was approved by CEN on 27 October 2017.

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, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-15:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-15:2017) 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 2018 and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-15:2017 has been approved by CEN as EN ISO 14644-15:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-15
First edition
2017-10
Cleanrooms and associated controlled
environments —
Part 15:
Assessment of suitability for use of
equipment and materials by airborne
chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de l'aptitude à l'emploi des équipements et
des matériaux par la détermination de la concentration chimique
aéroportée
Reference number
ISO 14644-15:2017(E)
©
ISO 2017
ISO 14644-15:2017(E)
© ISO 2017, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 14644-15:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 4
5 Test setup . 5
5.1 General . 5
5.2 Closed design . 5
5.3 Closed design special application . 6
5.4 Open design . 7
6 Representative mode . 7
6.1 Equipment . 7
6.2 Material . 7
7 Visual inspection . 8
7.1 General . 8
7.2 Equipment . 8
7.3 Material . 8
8 Test description . 9
9 Calculation of the measured concentrations . 9
10 Calculation of specific emission rate .10
10.1 Calculation of specific emission rate — Closed design .10
10.2 Calculation of specific emission rate — Open design .11
11 Assessment .11
11.1 General .11
11.2 Required input data .12
11.3 Calculation to determine the effect on a cleanroom or controlled zone .12
11.4 Assessment of the suitability of material(s) or equipment for an existing
cleanroom or controlled zone .13
12 Documentation .13
12.1 General .13
12.2 Common documentation requirements .13
12.3 Test documentation .14
12.4 Visual inspection .14
12.4.1 Equipment .14
12.4.2 Materials .14
Annex A (informative) Example calculation for suitability assessment of one equipment
(existing installation) .15
Annex B (informative) Example calculation for suitability assessment of wall material
(existing cleanroom/clean zone installation) .17
Annex C (informative) Suitability assessment of a combination of equipment and floor
material in a cleanroom to be designed .19
Bibliography .
...