EN ISO 14644-17:2021

Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)

This document gives direction on the interpretation and application of the results of the measurement of particle deposition rate on one or more vulnerable surfaces in a cleanroom as part of a contamination control programme. It provides some instructions on how to influence the particle deposition rate and reduce the risk of particle contamination on vulnerable surfaces.
This document gives information on how a cleanroom user can use the particle deposition rate measurements to determine limits that can be set for macroparticles on vulnerable surfaces. It also gives a risk assessment method by which an acceptable risk of deposition of particles onto vulnerable surfaces in a cleanroom can be established and, when this is not achieved, methods that can be used to reduce the particle deposition rate.
An alternative to the particle deposition rate is the particle obscuration rate which determines the rate of increase of coverage of particles onto an area of surface over time. The particle obscuration rate can be used in an analogous way to the particle deposition rate and the required particle obscuration rate for a specified surface can be calculated and the risk from deposited particles reduced.
This document does not:
—     provide a method to classify a cleanroom with respect to particle deposition rate or particle obscuration rate;
—     directly consider the deposition of microbe-carrying particles, although they can be treated as particles;
—     give any consideration to surface deposition by contact as, for example, when personnel touch a product and contamination is transferred.

Reinräume und zugehörige Reinraumbereiche - Teil 17: Anwendungen zur Partikelabscheidungsrate (ISO 14644-17:2021)

Dieses Dokument enthält Anweisungen für die Auswertung und Anwendung der Messergebnisse der Partikelablagerungsrate auf einer oder mehreren empfindlichen Oberflächen in einem Reinraum im Rahmen eines Programms zur Kontaminationskontrolle. Es umfasst ferner Anleitungen, wie die Partikelablagerungs-rate beeinflusst und die Gefahr einer partikulären Kontamination auf empfindlichen Oberflächen verringert werden kann.
Dieses Dokument beschreibt, wie Nutzer eines Reinraums mit Hilfe der Messungen der Partikelablagerungs-rate Grenzwerte festlegen können, die für Makropartikel auf empfindlichen Oberflächen gelten. Es umfasst ferner ein Verfahren zur Risikobewertung, mit dem ein annehmbares Risiko der Partikelablagerung auf empfindlichen Oberflächen in einem Reinraum ermittelt werden kann und, wenn dieses nicht erreicht wird, Verfahren, mit denen die Partikelablagerungsrate reduziert werden kann.
Eine Alternative zur Partikelablagerungsrate ist die partikuläre Trübungsrate, mit der die Anstiegsrate der Partikelansammlung auf einer bestimmten Fläche während einer bestimmten Zeit ermittelt werden kann. Die partikuläre Trübungsrate kann analog zur Partikelablagerungsrate angewandt werden, die erforderliche partikuläre Trübungsrate für eine bestimmte Oberfläche kann berechnet und das Risiko durch abgelagerte Partikel verringert werden.
Folgendes leistet dieses Dokument nicht:
- Bestimmung eines Verfahrens zur Klassifizierung eines Reinraums in Bezug auf die Partikelablagerungs-rate oder partikuläre Trübungsrate;
- direkte Betrachtung der Ablagerung mikrobentragender Partikel (MCP, en: microbe-carrying particles), wenngleich diese als Partikel behandelt werden können;
- Betrachtung der Ablagerung auf Oberflächen durch Kontakt, zum Beispiel wenn Mitarbeiter ein Produkt berühren und eine Kontamination auf diese Weise übertragen wird.

Salles propres et environnements maîtrisés apparentés - Partie 17: Applications de taux de dépôt de particules (ISO 14644-17:2021)

1      Domaine d'application  Le présent document donne des indications concernant l'interprétation et l'application des résultats du mesurage du taux de dépôt de particules sur une ou plusieurs surfaces sensibles dans une salle propre dans le cadre d'un programme de maîtrise de la contamination. Il fournit des instructions relatives à la manière d'influer sur le taux de dépôt de particules et de réduire le risque de contamination des surfaces sensibles par des particules.
Le présent document explique comment l'utilisateur d'une salle propre peut se servir des mesurages du taux de dépôt de particules pour déterminer les limites qui peuvent être définies pour les macroparticules sur les surfaces sensibles. Il propose également une méthode d'évaluation permettant d'établir un risque acceptable de dépôt de particules sur des surfaces sensibles dans une salle propre et, lorsque cela n'est pas réalisé, des méthodes pouvant être utilisées pour réduire le taux de dépôt de particules.
Le taux d'occultation par les particules constitue une alternative au taux de dépôt de particules; il permet de déterminer le taux d'augmentation de la zone de couverture des particules sur une surface dans le temps. Le taux d'occultation par les particules peut être utilisé de la même manière que le taux de dépôt de particules; il est possible de calculer le taux d'occultation par les particules requis pour une surface donnée et de réduire le risque de dépôt de particules.
Le présent document:
—          ne fournit pas de méthode permettant de classer une salle propre en fonction du taux de dépôt de particules ou du taux d'occultation par les particules;
—          ne traite pas directement du dépôt de particules porteuses de micro-organismes, bien que ces dernières puissent être considérées comme des particules;
—          ne s'applique pas aux dépôts en surface par contact, comme par exemple lorsque le personnel touche un produit et que la contamination est ainsi transférée.

Čiste sobe in podobna nadzorovana okolja - 17. del: Aplikacije glede hitrosti usedanja delcev (ISO 14644-17:2021)

General Information

• Status: Published
• Publication Date: 23-Feb-2021
• Withdrawal Date: 30-Aug-2021
• 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: 24-Feb-2021
• Completion Date: 24-Feb-2021
• Ref Project: SIST EN ISO 14644-17:2021 - Cleanrooms and associated controlled environments - Part 17: Particle deposition rate applications (ISO 14644-17:2021)

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2021
Čiste sobe in podobna nadzorovana okolja - 17. del: Aplikacije glede hitrosti
usedanja delcev (ISO 14644-17:2021)
Cleanrooms and associated controlled environments - Part 17: Particle deposition rate
applications (ISO 14644-17:2021)
Reinräume und zugehörige Reinraumbereiche - Teil 17: Anwendungen zur
Partikelabscheidungsrate (ISO 14644-17:2021)
Salles propres et environnements maîtrisés apparentés - Partie 17: Applications de taux
de dépôt de particules (ISO 14644-17:2021)
Ta slovenski standard je istoveten z: EN ISO 14644-17:2021
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 14644-17
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2021
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
17: Particle deposition rate applications (ISO 14644-
17:2021)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 17: Applications de taux de dépôt de particules 17: Anwendungen zur Partikelabscheidungsrate (ISO
(ISO 14644-17:2021) 14644-17:2021)
This European Standard was approved by CEN on 6 January 2021.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-17:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-17:2021) 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 August 2021, and conflicting national standards shall
be withdrawn at the latest by August 2021.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14644-17:2021 has been approved by CEN as EN ISO 14644-17:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-17
First edition
2021-02
Cleanrooms and associated controlled
environments —
Part 17:
Particle deposition rate applications
Salles propres et environnements maîtrisés apparentés —
Partie 17: Applications de taux de dépôt de particules
Reference number
ISO 14644-17:2021(E)
©
ISO 2021
ISO 14644-17:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 14644-17:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 3
5 Particle deposition rate methodology . 4
5.1 General . 4
5.2 Establishing the particle deposition rate required for control of particle deposition
on vulnerable surfaces . 4
5.3 Particle deposition rate for demonstrating control of particle contamination . 5
6 Measurement of particle deposition rate . 5
7 Particle deposition rate level . 6
8 Documentation . 7
Annex A (informative) Measurement of particle deposition rate . 8
Annex B (informative) Examples of particle deposition rate measurements .12
Annex C (informative) Measurement of the particle obscuration .16
Annex D (informative) Relationship between particle deposition rate and airborne
concentration of particles .19
Annex E (informative) Assessment and control of particle deposition .20
Bibliography .25
ISO 14644-17:2021(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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
A list of all parts in the ISO 14644 series can be found on the ISO website.
iv © ISO 2021 – All rights reserved

ISO 14644-17:2021(E)
Introduction
Cleanrooms and associated controlled environments are used to control contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit
from the control of contamination include those in industries such as aerospace, microelectronics,
optics, nuclear, food, healthcare, pharmaceuticals, and medical devices.
ISO 14644-1:2015 considers airborne particles in cleanrooms and classifies cleanroom cleanliness
by maximum permitted concentrations, and both ISO 14644-9:2012 and IEST -STD -CC1246E: 2013
consider the concentration of surface particles. This document considers the rate of particle deposition
[5]
onto cleanroom surfaces and is based on VCCN Guideline 9 . The particle deposition rate is important,
as the probability of contamination by airborne particles onto contamination sensitive, vulnerable
surfaces, such as manufactured products, is directly related to the particle deposition rate.
ISO 14644-3:2019 gives an overview of methods for the determination of deposition of particles, larger
or equal to 0,1 µm. In this document, the focus is on the rate that macroparticles larger than 5 µm
deposit on surfaces, and the application of this information to controlling contamination in cleanrooms.
Various sizes of particles are generated in cleanrooms by personnel, machinery, tools, and processes,
and distributed by air moving about the cleanroom. According to ISO 14644-1, cleanrooms and
controlled environments with a particle class of the ISO 5 series, or cleaner, contain zero or very low
concentrations of airborne particles larger than 5 µm. However, in operating cleanrooms, many more
particles in the size range of 5 µm to 500 µm, and greater, are found on surfaces than suggested by the
classification limits of the size of particles given in ISO 14644-1. The main reason for this is that the
largest particles in the range of sizes of macroparticles are not counted by particle counters because
of deposition losses in sampling tubes, and at the entry to and within particle counters. Also, for the
same reason, only a proportion of the smaller particle
...