ISO/TS 12869-2:2024

Water quality — Detection and quantification of Legionella spp. and/or Legionella pneumophila by concentration and genic amplification by quantitative polymerase chain reaction (qPCR) — Part 2: On-site methods

This document provides the guidelines, minimum requirements and performance characteristics intended to guarantee that manufactured systems intended for on-site/field use (i.e. outside the laboratory) provide reliable and reproducible results. This document specifies the requirements for technologies that enable on-site detection and quantification of Legionella spp. and L. pneumophila using a quantitative polymerase chain reaction assay (qPCR). It specifies general methodological requirements, performance evaluation requirements and quality control requirements. This document is intended to be used by manufacturers of these technologies so that they produce detection systems that end users can operate safely and effectively. End users will be guided by this document to adhere to manufacturer’s instructions, to ensure user competency and to perform the necessary controls. Technical details specified in this document are given for information only. Any other technical solutions complying with the performance requirements are suitable. NOTE For validation and performance requirements, see Clause 9. This document is intended to be applied in the bacteriological investigation of all types of water (hot or cold water, cooling tower water, etc.), unless the nature and/or content of suspended matter and/or background microorganisms interfere with the determination. This interference can result in an adverse effect on both the detection limit and the quantification limit. The results are expressed as the number of genome units of Legionella spp. and/or L. pneumophila per millilitre (or litre) of sample. Although the method described in this document is applicable to all types of water, some additives, such as chemicals used for water treatment, can interfere with and/or affect the sensitivity of the method. The qPCR methods do not give any information about the physiological state of the Legionella. However, there are on-site qPCR methodologies which are able to distinguish intact bacteria from free DNA.

Qualité de l'eau — Détection et quantification de Legionella spp. et/ou Legionella pneumophila par concentration et amplification génique par réaction de polymérisation en chaîne quantitative (qPCR) — Partie 2: Méthodes sur site

General Information

• Status: Published
• Publication Date: 04-Apr-2024
• ICS: 07.100.20 - Microbiology of water
• Technical Committee: ISO/TC 147/SC 4 - Microbiological methods
• Drafting Committee: ISO/TC 147/SC 4 - Microbiological methods
• Current Stage: 6060 - International Standard published
• Start Date: 05-Apr-2024
• Due Date: 25-Apr-2025
• Completion Date: 05-Apr-2024

Standards Content (Sample)

Technical
Specification
ISO/TS 12869-2
First edition
Water quality — Detection and
2024-04
quantification of Legionella spp.
and/or Legionella pneumophila
by concentration and genic
amplification by quantitative
polymerase chain reaction
(qPCR) —
Part 2:
On-site methods
Qualité de l'eau — Détection et quantification de Legionella spp.
et/ou Legionella pneumophila par concentration et amplification
génique par réaction de polymérisation en chaîne quantitative
(qPCR) —
Partie 2: Méthodes sur site
Reference number
ISO/TS 12869-2:2024(en) © ISO 2024

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ISO/TS 12869-2:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland

© ISO 2024 – All rights reserved
ii

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ISO/TS 12869-2:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, symbols and abbreviated terms . 2
3.1 Terms and definitions .2
3.2 Symbols and abbreviated terms .3
4 Principle . 4
5 Sampling . 4
6 General testing conditions . 5
6.1 General .5
6.2 End users .5
6.2.1 General .5
6.2.2 Manufacturer’s instructions .5
6.2.3 Proficiency .6
6.2.4 Usability validation (human factors testing [HFT]) .6
6.3 Premises .
...

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 12869-2
ISO/TC 147/SC 4
Water quality — Detection and
Secretariat: DIN
quantification of Legionella spp.
Voting begins on:
2023-10-30 and/or Legionella pneumophila by
concentration and genic amplification
Voting terminates on:
2023-12-25
by quantitative polymerase chain
reaction (qPCR) —
Part 2:
On-site methods
Qualité de l'eau — Détection et quantification de Legionella spp.
et/ou Legionella pneumophila par concentration et amplification
génique par réaction de polymérisation en chaîne quantitative
(qPCR) —
Partie 2: Méthodes sur site
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/DTS 12869-2:2023(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/DTS 12869-2:2023(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 12869-2
ISO/TC 147/SC 4
Water quality — Detection and
Secretariat: DIN
quantification of Legionella spp.
Voting begins on:
and/or Legionella pneumophila by
concentration and genic amplification
Voting terminates on:
by quantitative polymerase chain
reaction (qPCR) —
Part 2:
On-site methods
Qualité de l'eau — Détection et quantification de Legionella spp.
et/ou Legionella pneumophila par concentration et amplification
génique par réaction de polymérisation en chaîne quantitative
(qPCR) —
Partie 2: Méthodes sur site
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: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 12869-2:2023(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/DTS 12869-2:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, symbols and abbreviated terms . 2
3.1 Terms and definitions . 2
3.2 Symbols and abbreviated terms . 3
4 Principle . 4
5 Sampling .
...

© ISO 2023 – All rights reserved
ISO/TC 147/SC 4
Date: 2023-05
ISO/DTS TS 12869--2:2023(E)
ISO/TC 147/SC 4
Secretariat: DIN
Water quality — Detection and quantification of Legionella spp. and/or Legionella pneumophila
by concentration and genic amplification by quantitative polymerase chain reaction (qPCR) —
Part 2: On-site methods
Qualité de l'eau — Détection et quantification de Legionella spp. et/ou Legionella pneumophila par
concentration et amplification génique par réaction de polymérisation en chaîne quantitative (qPCR) –
Partie 2: Méthodes sur site

DTS 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.

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© ISOFirst edition
Date: 2023-10-16

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ISO/TS 12869-2:2023(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 Office
CP 401 • CH. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: [e-mail] [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland.
ii © ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/TS 12869-2:2023(E)
Contents
Foreword . 5
Introduction . 6
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, symbols and abbreviated terms . 2
3.1 Terms and definitions . 2
3.2 Symbols and abbreviated terms . 3
4 Principle . 4
5 Sampling . 4
6 General testing conditions . 5
6.1 General . 5
6.2 End users . 5
6.2.1 General . 5
6.2.2 Manufacturer’s instructions . 6
6.2.3 Proficiency . 7
6.2.4 Usability validation (human factors testing [HFT]) . 7
6.3 Premises . 7
6.3.1 Manufacturer premises . 7
6.3.2 End user premises . 8
6.4 Apparatus and consumables (excluding reagents) . 8
6.4.1 General
...