EN ISO 23783-3:2023
(Main)Automated liquid handling systems - Part 3: Determination, specification and reporting of volumetric performance (ISO 23783-3:2022)
Automated liquid handling systems - Part 3: Determination, specification and reporting of volumetric performance (ISO 23783-3:2022)
This document provides guidance and establishes requirements for collecting and examining volumetric performance data of automated liquid handling systems (ALHS). It specifies how to index and track volumetric performance data and provides descriptive statistics for the evaluation of these data. This document also specifies reporting requirements of ALHS volumetric performance.
This document is applicable to all ALHS with complete, installed liquid handling devices, including tips and other essential parts needed for delivering a specified volume, which perform liquid handling tasks without human intervention into labware.
NOTE For terminology and general requirements of automated liquid handling systems, see ISO 23783-1. Measurement procedures for the determination of volumetric performance are given in ISO 23783-2.
Automatisierte Flüssigkeitsdosiersysteme - Teil 3: Bestimmung, Spezifikation und Protokollierung der volumetrischen Leistung (ISO 23783-3:2022)
Dieses Dokument enthält Anleitungen und legt Anforderungen an die Erfassung und Prüfung von volumetrischen Leistungsdaten von automatisierten Flüssigkeitsdosiersystemen (ALHS) fest. Es legt fest, wie die volumetrischen Leistungsdaten zu indizieren und zu verfolgen sind, und stellt deskriptive Statistiken für die Auswertung dieser Daten bereit. Dieses Dokument legt auch die Anforderungen an die Dokumentation der volumetrischen Leistung von ALHS fest.
Dieses Dokument ist anwendbar für alle ALHS mit vollständigen, installierten Flüssigkeitsdosiersystemen, einschließlich Spitzen und anderer wesentlicher Teile, die für die Dosierung eines bestimmten Volumens benötigt werden und die Flüssigkeitsdosier-Aufgaben ohne menschliches Zutun in Laborgeräten durchführen.
ANMERKUNG Zur Terminologie und den allgemeinen Anforderungen an automatisierte Flüssigkeitsdosiersysteme siehe ISO 23783 1. Messverfahren zur Bestimmung der volumetrischen Leistung sind in ISO 23783 2 angegeben.
Systèmes automatisés de manipulation de liquides - Partie 3: Détermination, spécification et compte-rendu des performances volumétriques (ISO 23783-3:2022)
Le présent document fournit des recommandations et établit les exigences relatives à la collecte et à l’analyse des données de performances volumétriques des systèmes automatisés de manipulation de liquides (ALHS). Il spécifie la méthode d’indexation et de suivi des données de performances volumétriques et fournit des statistiques descriptives pour l’évaluation de ces données. Le présent document spécifie également les exigences de compte‑rendu des performances volumétriques des ALHS.
Le présent document s’applique à tous les ALHS dans lesquels sont installés des dispositifs complets de manipulation de liquides, y compris les cônes et autres composants essentiels nécessaires à la distribution d’un volume spécifié, qui exécutent des tâches de manipulation de liquides avec du matériel de laboratoire, sans intervention humaine.
NOTE Pour la terminologie et les exigences générales applicables aux systèmes automatisés de manipulation de liquides, voir l’ISO 23783‑1. Les procédures de mesure pour la détermination des performances volumétriques sont décrites dans l’ISO 23783‑2.
Avtomatizirani sistemi za ravnanje s tekočinami - 3. del: Določanje, specifikacija in poročanje o prostorninski zmogljivosti (ISO 23783-3:2022)
Ta dokument podaja navodila in določa zahteve za zbiranje in preučevanje podatkov o volumetrični zmogljivosti avtomatiziranih sistemov za ravnanje s tekočinami (ALHS). Določa, kako indeksirati in slediti podatkom volumetrične zmogljivosti, in podaja opisno statistiko za ocenjevanje teh podatkov. Dokument določa tudi zahteve za poročanje o volumetrični zmogljivosti avtomatiziranih sistemov za ravnanje s tekočinami.
Ta dokument se uporablja za vse avtomatizirane sisteme za ravnanje s tekočinami s popolnimi, nameščenimi napravami za ravnanje s tekočinami, vključno s konicami in drugimi bistvenimi deli, ki so potrebni za dovajanje določene količine. Gre za sisteme, ki izvajajo opravila ravnanja s tekočinami brez človeškega posredovanja v laboratorijsko opremo.
OPOMBA: Za terminologijo in splošne zahteve avtomatiziranih sistemov za ravnanje s tekočinami glej standard ISO 23783-1. Postopki merjenja za določanje volumetrične zmogljivosti so podani v standardu ISO 23783-2.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Avtomatizirani sistemi za ravnanje s tekočinami - 3. del: Določanje, specifikacija in
poročanje o prostorninski zmogljivosti (ISO 23783-3:2022)
Automated liquid handling systems - Part 3: Determination, specification and reporting of
volumetric performance (ISO 23783-3:2022)
Automatisierte Flüssigkeitsdosiersysteme - Teil 3: Bestimmung, Spezifikation und
Protokollierung der volumetrischen Leistung (ISO 23783-3:2022)
Systèmes automatisés de manipulation de liquides - Partie 3: Détermination,
spécification et compte-rendu des performances volumétriques (ISO 23783-3:2022)
Ta slovenski standard je istoveten z: EN ISO 23783-3:2023
ICS:
17.060 Merjenje prostornine, mase, Measurement of volume,
gostote, viskoznosti mass, density, viscosity
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 23783-3
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2023
EUROPÄISCHE NORM
ICS 17.060; 71.040.20
English Version
Automated liquid handling systems - Part 3:
Determination, specification and reporting of volumetric
performance (ISO 23783-3:2022)
Systèmes automatisés de manipulation de liquides - Automatisierte Flüssigkeitsdosiersysteme - Teil 3:
Partie 3: Détermination, spécification et compte-rendu Bestimmung, Spezifikation und Protokollierung der
des performances volumétriques (ISO 23783-3:2022) volumetrischen Leistung (ISO 23783-3:2022)
This European Standard was approved by CEN on 25 September 2023.
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, Türkiye 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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23783-3:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
The text of ISO 23783-3:2022 has been prepared by Technical Committee ISO/TC 48 "Laboratory
equipment” of the International Organization for Standardization (ISO) and has been taken over as
which is held by DIN.
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 April 2024, and conflicting national standards shall be
withdrawn at the latest by April 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 23783-3:2022 has been approved by CEN as EN ISO 23783-3:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 23783-3
First edition
2022-08
Automated liquid handling systems —
Part 3:
Determination, specification and
reporting of volumetric performance
Systèmes automatisés de manipulation de liquides —
Partie 3: Détermination, spécification et compte-rendu des
performances volumétriques
Reference number
ISO 23783-3:2022(E)
ISO 23783-3:2022(E)
© ISO 2022
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 23783-3:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 1
5 Volumetric performance .2
5.1 General . 2
5.2 Data collection and examination . 3
5.3 Indexing to track data . 4
5.3.1 General . 4
5.3.2 Indexing from the channel perspective . 4
5.3.3 Indexing from the microplate perspective . 4
5.4 Descriptive statistics on an individual channel basis . 5
5.4.1 General . 5
5.4.2 Average volume . 5
5.4.3 Systematic error . 5
5.4.4 Random error . 6
5.5 Descriptive statistics on a run order basis . . 7
5.6 Descriptive statistics for entire data sets . 8
5.7 Differences between channels . 8
5.8 Volume increments . 9
6 Reporting . 9
6.1 Reporting of the results . 9
6.1.1 General . 9
6.1.2 Test reports and calibration certificates . 9
6.1.3 Calibration certificates . 10
6.1.4 As-found and as-left reporting . 11
6.1.5 Calibration interval recommendation. 11
Annex A (informative) Applications of descriptive statistics .12
Bibliography .21
iii
ISO 23783-3:2022(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 48, Laboratory equipment.
This first edition of ISO 23783-3, together with ISO 23783-1 and ISO 23783-2, cancels and replaces
IWA 15:2015.
A list of all parts in the ISO 23783 series can be found on the ISO website.
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.
iv
ISO 23783-3:2022(E)
Introduction
Globalization of laboratory operations requires standardized practices for operating automated
liquid handling systems (ALHS), communicating test protocols, as well as analysing and reporting
of performance parameters. IWA 15:2015 was developed to provide standardized terminology, test
protocols, and analytical methods for reporting test results. The concepts developed for, and described
in, IWA 15 form the foundation of the ISO 23783 series.
Specifically, this document addresses the needs of:
— users of ALHS, as a basis for calibration, verification, validation, optimization, and routine testing of
trueness and precision;
— manufacturers of ALHS, as a basis for quality control, communication of acceptance test specifications
and conditions, and issuance of manufacturer’s declarations (where appropriate);
— test houses and other bodies, as a basis for certification, calibration, and testing.
The tests established in this document should be carried out by trained personnel.
v
INTERNATIONAL STANDARD ISO 23783-3:2022(E)
Automated liquid handling systems —
Part 3:
Determination, specification and reporting of volumetric
performance
1 Scope
This document provides guidance and establishes requirements for collecting and examining
volumetric performance data of automated liquid handling systems (ALHS). It specifies how to index
and track volumetric performance data and provides descriptive statistics for the evaluation of these
data. This document also specifies reporting requirements of ALHS volumetric performance.
This document is applicable to all ALHS with complete, installed liquid handling devices, including tips
and other essential parts needed for delivering a specified volume, which perform liquid handling tasks
without human intervention into labware.
NOTE For terminology and general requirements of automated liquid handling systems, see ISO 23783-1.
Measurement procedures for the determination of volumetric performance are given in ISO 23783-2.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 23783-1, Automated liquid handling systems — Part 1: Terminology and general requirements
ISO 23783-2:2022, Automated liquid handling systems — Part 2: Measurement procedures for the
determination of volumetric performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 23783-1 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Abbreviated terms
For the purposes of this document, the abbreviated terms given in ISO 23783-1 apply.
ISO 23783-3:2022(E)
5 Volumetric performance
5.1 General
Automated liquid handling systems (ALHS) are designed to deliver amounts of liquid at a target volume.
The target volume is typically set using software or other digital control. Volumetric performance shall
be assessed by measuring the volume of each liquid delivery and evaluating the data.
Volumetric performance is typically assessed as part of the manufacturing process quality control.
Subsequent volumetric performance assessments can be done by suppliers, users, as well as by third-
party testing and calibration service providers.
Automated liquid handling systems are designed to handle a variety of liquids of differing physical
properties such as density, viscosity, surface tension and contact angle against solid surfaces. Test
liquids can be aqueous or other solvents. Aqueous test liquids can be pure water or contain other
compounds such as acids, bases, salts, dyes, or other inorganic, organic, or biological compounds. The
chemical composition of the test liquid can vary significantly depending on the method and should
reflect the liquid used by the ALHS as closely as possible. Since the volumetric performance of the ALHS
can vary depending on these physical properties, a description of the test liquid shall be included when
reports of volumetric performance are made. This description of the test liquid may be made in terms
of chemical composition, physical properties, or both.
ALHS shall be supplied with performance claims at various volumes for a particular instrument
configuration. The maximum specified volume and minimum specified volume establish a liquid
handling range for which established volumetric performance specifications are available. The
maximum specified volume and minimum specified volume can vary depending on instrument
configuration (e.g. disposable tip size, syringe size).
NOTE In preparing for a volumetric performance test, the ALHS will be set to deliver a particular target
volume. During testing, each delivered volume is expected to be slightly different from the target volume.
The delivered volume is a conceptual quantity because it cannot be known with certainty and can only be
approximated by measurement.
In order to evaluate volumetric performance, measurements are made of individual delivered volumes.
The measured volume differs slightly from the true delivered volume due to measurement system
error, which can be expressed as measuring system uncertainty (MSU). This value should be expressed
in accordance with ISO/IEC Guide 98-3.
Accuracy of the ALHS can be improved by improving precision and trueness. These concepts and their
inter-dependencies are illustrated in Figure 1. Improving precision brings the cluster of the results into
a smaller bunch, while improved trueness occurs when the centre of the cluster is closer to the centre
of the target.
Accuracy, precision and trueness are conceptual terms. Quantitative expressions of these concepts are
given in terms of error, random error and systematic error, respectively.
ISO 23783-3:2022(E)
Key
1 improving trueness, decreasing systematic errors
2 improving precision, decreasing random errors
3 improving accuracy, decreasing both systematic and random errors
Figure 1 — Relationship between trueness, precision, and accuracy of an ALHS
5.2 Data collection and examination
ALHS test results shall include data sets of individual measured volumes, and descriptive statistics
which summarize the data sets. Systematic error and random error are two examples of descriptive
statistics which are commonly employed in the testing of ALHS.
Each instance of a delivered volume shall be measured to determine a measured volume, V. Measured
volumes shall be determined in accordance with one of the measurement methods described in
ISO 23783-2.
Prior to calculating descriptive statistics, it is recommended that the measured volumes be visually
examined for evidence of outliers, trending, or patterns. Such features can indicate the need for more
detailed analysis, optimization, or additional testing to determine the cause. For the purposes of this
document, outliers are considered to be unusual results that cannot be reliably repeated. Trending
refers to results that vary in a regular way when viewed by time or dispense order. It is possible to
observe patterns when viewing data in a spatial arrangement such as by examining results distributed
in a plate arrangement. Visualization aids such as heat mapping may be used to help identify patterns.
The presence of outliers, trending or patterns can indicate the need for further investigation, including
optimization or repair of the ALHS.
NOTE 1 Statistical consideration of outliers is beyond the scope of this document.
NOTE 2 The formulae presented in this document are sufficient to describe volumetric data that are normally
distributed. When data are not normally distributed, it can be necessary to provide additional information to
adequately describe ALHS performance (see Reference [2] for more details). For example, ALHS which exhibit
trending, as well as multi-dispensing modes are two cases where volumetric data are not normally distributed.
ISO 23783-3:2022(E)
5.3 Indexing to track data
5.3.1 General
With multiple different channels, replicates and experimental possibilities, an identification scheme is
needed to keep track of the data.
NOTE Additional explanations and examples of the indexing scheme can be found in Reference [3].
5.3.2 Indexing from the channel perspective
Viewed from the perspective of the liquid handler, each volume delivery can be given an index number
in the form of an ordered triplet of integers (l,m,n) where:
l is an index for the dispensing channel and the value ranges from 1 to L. The variable L is the
number of dispensing channels per ALHS. L can be as small as 1 for the case of a single channel
device, to 384 or greater.
m is an index for a reproducible experiment, and the value ranges from 1 to M. The variable M is
used to track different experiments under different reproducibility conditions. For example,
replicates of prior experiments when assessing reproducibility or drift over longer time periods.
n is an index for delivery order within a single repeatability test (run) and the value ranges
from 1 to N. The variable N is the number of replicates in a repeatability test (run) where the
volumes are delivered in a short period of time under nearly identical repeatability conditions.
One repeatability test can require the use of multiple microplates.
In this way, a measured volume V of the n-th delivery by the l-th channel, during the m-th experiment is
given by the symbol V(l,m,n).
This document does not specify a minimum number of replicates for routine testing, and a minimum of
10 replicates for calibration of ALHS (see ISO 23783-1:2022, 6.5). The number of replicates (N) shall be
reported when repeatability data are used to calculate averages or standard deviations as the reliability
of these descriptive statistics depends on the number of replicates.
The channel perspective is recommended for purposes of evaluating volumetric performance and
determining whether particular channels are performing correctly. Alternative indexing systems such
as the microplate perspective are described in 5.3.3. Examples illustrating these systems are provided
in Annex A.
5.3.3 Indexing from the microplate perspective
When volumes are dispensed into microplates for measurement, it is common to index by row, column,
and plate. In 96- and 384-well microplates, it is common for rows to be designated by letters (e.g. A
through H, and A through P, respectively) while columns are numbered (1 through 12, and 1 through
24, respectively). This viewpoint is recommended for evaluating precision, trueness, or accuracy from a
plate perspective. Indexing schemes are not mutually exclusive. When volume measurements are made
in microplates, knowledge of the liquid handling system programming allows the data from the rows,
columns and plates to be translated into the channel, run, and dispense order.
It is not necessary to consider different plates to be different experiments. For example, a 96-tip head
could be tested by making a series of deliveries into three 96-well plates. In this case, plates 1, 2 and 3
can be considered to be dispense replicates n = 1, 2 and 3, while all three plates are considered part of a
single experiment.
NOTE 1 An example of the above-mentioned scenario is included in A.5.
ISO 23783-3:2022(E)
NOTE 2 Frequently there is interest in “within plate” variation or variation and patterns across different
plates. For example, when patterns are observed within a plate, it can be of interest whether the pattern is
repeatable across additional plates. Also, when evaluating different ALHS for a particular application, it can be
useful to evaluate data from the plate perspective without regard to the arrangements of independent channels
and thus simply compare the whole plate precision of two different systems.
5.4 Descriptive statistics on an individual channel basis
5.4.1 General
An ALHS typically performs a series of N replicate deliveries of the target volume, which are averaged
to calculate the actual delivered volume. These N replicates are usually delivered within a short period
of time under repeatability conditions and are referred to as a “run.” The ALHS can be programmed so
that a run is preceded by one or more pre-deliveries of test liquid. Pre-deliveries should be performed
after a period of ALHS inactivity or changes to the ALHS parameters (e.g. target volume, liquid class,
test liquid), and should be delivered into the waste. The reproducibility between experiments (M) is
increased if each run is started under similar, well-defined test conditions.
5.4.2 Average volume
The average volume delivered by a particular channel during a particular run is given in Formula (1).
This average volume can then be used to calculate both systematic and random errors.
N
Vl(,m)(=× Vl,,mn) (1)
∑
N
n=1
...
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