Cleanrooms and associated controlled environments — Part 21: Airborne particle sampling techniques

This document discusses the physical limitations of probe and particle counter placement, and any tubing that connects the two, particularly in providing representative samples where particles 5 micrometres and greater are of interest. The document further identifies the key factors of sampling performance when classifying and monitoring, and good practice to determine and maintain an acceptable compromise between attainable accuracy in counting and feasibility of counting in real-life situations. This document includes a decision tree, used to identify key considerations when sampling airborne particles, and whether the system requires further assessment. There are also examples provided to illustrate typical application challenges and show how the decision tree can be used. It is assumed that this document is read in conjunction with ISO 14644-1 and ISO 14644-2. This document is not a manual, but an explanatory document. It does not describe measurement methods, which is handled in ISO 14644-1 and ISO 14644-2, but provides information to help make effective choices of sampling configuration, when evaluating a new or existing system.

Salles propres et environnements maîtrisés apparentés — Partie 21: Techniques de prélèvement des particules en suspension dans l’air

Le présent document traite des limites physiques de l’emplacement des sondes et des compteurs de particules, ainsi que des tubes qui les relient, en particulier lorsqu’il s’agit de fournir des échantillons représentatifs lorsque des particules de 5 micromètres ou plus sont considérées. Le document définit en outre les facteurs clés de la performance du prélèvement lors de la classification et de la surveillance, ainsi que les bonnes pratiques permettant de déterminer et de maintenir un compromis acceptable entre la précision et la faisabilité du comptage dans des situations réelles. Le présent document comprend un arbre de décision qui permet d’identifier les éléments clés à prendre en compte lors du prélèvement des particules en suspension dans l’air et de déterminer si le système requiert une évaluation plus poussée. Des exemples sont également fournis pour illustrer les difficultés posées par les applications typiques et montrer comment cet arbre de décision peut être utilisé. Il est présumé que ce document est lu conjointement avec l’ISO 14644-1 et l’ISO 14644-2. Le présent document n’est pas un manuel, mais un document explicatif. Il ne décrit pas les méthodes de mesurage, qui sont traitées dans l’ISO 14644-1 et l’ISO 14644-2, mais fournit des informations pour aider à choisir efficacement la configuration du prélèvement, lors de l’évaluation d’un nouveau système ou d’un système existant.

General Information

Status
Published
Publication Date
17-Aug-2023
Current Stage
6060 - International Standard published
Start Date
18-Aug-2023
Completion Date
18-Aug-2023
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TECHNICAL ISO/TR
REPORT 14644-21
First edition
2023-08
Cleanrooms and associated controlled
environments —
Part 21:
Airborne particle sampling techniques
Salles propres et environnements maîtrisés apparentés —
Partie 21: Techniques de prélèvement des particules en suspension
dans l’air
Reference number
ISO/TR 14644-21:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO/TR 14644-21:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TR 14644-21:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative documents . 1
3 Terms and definitions . 1
4 Determination of airborne particle concentration . 2
4.1 General . 2
4.2 Classification . 3
4.3 Monitoring . 4
4.4 Other LSAPC applications . 4
5 Sampling airborne particles – things to consider . 5
5.1 General . 5
5.2 Instrument selection . 5
5.2.1 General . 5
5.2.2 Considered particle size selection . 6
5.2.3 Required sample volume and sample flow rate . 7
5.3 State of occupancy . 7
5.3.1 General . 7
5.4 Sample locations – points to consider. 7
5.4.1 Ge
...

FINAL
TECHNICAL ISO/DTR
DRAFT
REPORT 14644-21
ISO/TC 209
Cleanrooms and associated controlled
Secretariat: ANSI
environments —
Voting begins on:
2023-06-01
Part 21:
Voting terminates on:
Airborne particle sampling techniques
2023-07-27
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTR 14644-21:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 1 ----------------------
ISO/DTR 14644-21:2023(E)
FINAL
TECHNICAL ISO/DTR
DRAFT
REPORT 14644-21
ISO/TC 209
Cleanrooms and associated controlled
Secretariat: ANSI
environments —
Voting begins on:
2023-06-01
Part 21:
Voting terminates on:
Airborne particle sampling techniques
2023-07-27
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTR 14644-21:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/DTR 14644-21:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative documents . 1
3 Terms and definitions . 1
4 Determination of airborne particle concentration . 2
4.1 General . 2
4.2 Classification . 3
4.3 Monitoring . 4
4.4 Other LSAPC Applications . 4
5 Sampling Airborne Particles – Things to Consider . 5
5.1 General . 5
5.2 Instrument Selection.
...

ISO /DTR 14644-21:2023(E)
ISO/TC 209 WG 15
Secretariat: ANSI/IEST
Date: 2023-05-30
ISO/DTR 14644-21:2023— — Cleanrooms and associated controlled environments—
Airborne particle sampling techniques

DTR stage

Warning for WDs and CDs
This document is not an ISO International Standard. It is distributed for review and comment. It is subject
to change without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.

---------------------- Page: 1 ----------------------
ISO/DTR 14644-21:2023(E)
© ISO 2022
2 © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DTR 14644-21:2023(E)
© ISO 2023
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’sISO's member body in the country of the requester.
ISO copyright officeCopyright Office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: copyright@iso.org
Email: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland.

ii © ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/DTR 14644-21:2023(E)
Contents
Foreword . 4
Introduction . 5
1 Scope . 6
2 Normative documents . 6
3 Terms and definitions . 6
4 Determination of airborne particle concentration . 7
4.1 General . 7
4.2 Classification . 8
4.3 Monitoring . 9
4.4 Other LSAPC Applications . 10
5 Sampling Airborne Particles – Things to Consider . 10
5.1 General . 10
5.2 Instrument Selection . 10
5.2.1 Considered Particle Size Selection . 11
5.2.2 Required sample volume and sample flow rate . 12
5.3 State of Occupancy . 12
5.4 Sample Locations – points to consider. 12
5.4.1 Sampling Locations for Classification . 12
5.4.2 Sample Locations for Monitoring . 14
5.5 Instrument Measurement Issues . 15
5.5.1 Sampling Errors . 15
5.5.2 Sample Measurement Errors . 17
5.5.3 Sample tubing issues . 19
5.6 Decision Tree . 21
5.7 Examples of use of the Decision Tree . 23
5.7.1 Example 1
...

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