oSIST prEN ISO 23783-1:2023

SLOVENSKI STANDARD
oSIST prEN ISO 23783-1:2023
01-julij-2023
Avtomatizirani sistemi za ravnanje s tekočinami - 1. del: Slovar in splošne zahteve
(ISO 23783-1:2022)
Automated liquid handling systems - Part 1: Vocabulary and general requirements (ISO
23783-1:2022)
Automatisierte Flüssigkeitsdosiersysteme - Teil1: Terminologie und allgemeine
Anforderungen (ISO 23783-1:2022)
Systèmes automatisés de manipulation de liquides - Partie 1: Vocabulaire et exigences
générales (ISO 23783-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 23783-1
ICS:
01.040.71 Kemijska tehnologija Chemical technology
(Slovarji) (Vocabularies)
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
oSIST prEN ISO 23783-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 23783-1:2023

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oSIST prEN ISO 23783-1:2023
INTERNATIONAL ISO
STANDARD 23783-1
First edition
2022-08
Automated liquid handling systems —
Part 1:
Vocabulary and general requirements
Systèmes automatisés de manipulation de liquides —
Partie 1: Vocabulaire et exigences générales
Reference number
ISO 23783-1:2022(E)
© ISO 2022

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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 9
5 Operation of automated liquid handling systems .10
5.1 Types of automated liquid handling systems . 10
5.1.1 General . 10
5.1.2 Piston-operated automated liquid handling systems . 10
5.1.3 Pump operated automated liquid handling systems . 11
5.1.4 Automated liquid handling systems using inkjet-type dispensing
technologies . 11
5.1.5 Automated liquid handling systems using acoustic droplet ejection
technology . 11
5.1.6 Pin tools .12
5.2 Types of pipette tips for ALHS .12
5.2.1 General .12
5.2.2 Air-displacement tips .12
5.2.3 Positive displacement tips .12
5.2.4 Fixed tips .13
5.3 Cleaning of re-usable components and confirmation of metrological characteristics .13
6 Testing and calibration of ALHS .13
6.1 Metrological confirmation .13
6.1.1 General .13
6.1.2 Calibration . . .13
6.1.3 Routine tests . 14
6.2 Channels to test . 14
6.3 Test volumes . 14
6.4 Test liquids . 14
6.5 Replicate measurements . 14
6.6 Test frequency . 14
6.7 Test methods . 15
6.8 Exchangeable components .15
6.8.1 Automatically exchangeable components . 15
6.8.2 Manually exchangeable components . 15
6.8.3 Other exchangeable components . 15
6.9 Firmware and software updates . 15
6.10 Environmental conditions . 16
6.10.1 General . 16
6.10.2 Factory acceptance testing. 16
6.10.3 Site acceptance testing . . 16
6.11 Adjustments . 17
6.11.1 General . 17
6.11.2 Liquid classes . 17
6.11.3 Adjustment of ALHS settings . . 17
6.12 Correction . 17
6.13 Reporting of results . 18
7 Specification of ALHS volumetric performance.18
7.1 Information to be supplied with the ALHS . 18
7.2 Optional information . 18
Bibliography .19
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(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 23783-1, together with ISO 23783-2 and ISO 23783-3, 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.
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(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.
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oSIST prEN ISO 23783-1:2023
INTERNATIONAL STANDARD ISO 23783-1:2022(E)
Automated liquid handling systems —
Part 1:
Vocabulary and general requirements
1 Scope
This document defines terms relating to automated liquid handling systems (ALHS). This document
also specifies general requirements for the use of ALHS. It describes types of ALHS and specific
use requirements, settings, and adjustments for each ALHS type. It also specifies environmental
requirements for the use of ALHS.
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 Measurement procedures for the determination of volumetric performance are given in ISO 23783-2.
The determination, specification, and reporting of volumetric performance of automated liquid handling systems
are described in ISO 23783-3.
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 23783-2, Automated liquid handling systems — Part 2: Measurement procedures for the determination
of volumetric performance
ISO 23783-3:2022, Automated liquid handling systems — Part 3: Determination, specification, and
reporting of volumetric performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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/
3.1
accuracy
accuracy of liquid delivery
closeness of agreement between the delivered volume and the target volume
Note 1 to entry: The concept "accuracy" is not given a numerical value. A liquid delivery is said to be more
accurate when it is made with a smaller error.
Note 2 to entry: The term "accuracy" shall not be used for "trueness" and the term "precision" should not be used
for ‘accuracy,’ which, however, is related to both of these concepts.
Note 3 to entry: The relationship between accuracy, systematic error, and random error of an automated liquid
handling system is explained further in ISO 23783-3:2022, 5.1.
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
[SOURCE: ISO/IEC Guide 99:2007, 2.13, modified — definition and Notes 1 and 2 were modified for the
context of automated liquid handling and Note 3 was replaced.]
3.2
air displacement
liquid handling principle in which a body of air is contained between the
piston and the test liquid
Note 1 to entry: It is possible to have a large air gap (piston systems), or a smaller air gap between the test liquid
and the system liquid (liquid filled systems).
3.3
air gap
captive air volume
dead air volume
air volume between the lower part of the piston and the surface of the
aspirated liquid
Note 1 to entry: It is possible to have a large air gap (piston systems), or a smaller air gap for liquid filled systems.
3.4
automated liquid handling system
ALHS
system with a complete, installed liquid handling device, including tips and other essential components
needed for delivering a specified volume without human intervention into labware
Note 1 to entry: Examples of automated liquid handling systems include automated pipetting systems (APS), and
automated dispensing systems (ADS).
3.5
calibration
operation that, under specified conditions, establishes a relation between the target volume of
the ALHS and the delivered volume
Note 1 to entry: A calibration may be expressed by a statement, a calibration curve or a calibration table. It may
include a correction, but correction or adjustment is not a required element of a calibration.
[SOURCE: ISO/IEC Guide 99:2007, 2.39, modified — definition was simplified and modified for the
context of automated liquid handling; Note 1 was simplified and Notes 2 and 3 were deleted.]
3.6
correction
mathematical compensation for a systematic effect
Note 1 to entry: The mathematical compensation can take different forms, such as an addend or a factor, or can
be deducted from a table.
[SOURCE: ISO/IEC Guide 99:2007, 2.53, modified – added mathematical to the definition and Note 2,
deleted estimated from the definition, and Note 1 was deleted.]
3.7
delivered volume
quantity delivered by a liquid handling system
Note 1 to entry: Delivered volume is a conceptual term and cannot be known with complete certainty due to
measurement error.
3.8
dispense height
initial distance at which the test liquid is dispensed relative to a stated reference
Note 1 to entry: Dispensing from an initial fixed distance relative to the liquid surface will decrease the dispense
height as the liquid level rises.
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
Note 2 to entry: Dispensing from a fixed distance relative to the well bottom will not change the dispense height
over the course of the dispense.
Note 3 to entry: Dispensing and adjusting the distance relative to the liquid surface will not change the dispense
height over the course of the dispense. This is an operational mode possible with some ALHS liquid level detection
systems.
Note 4 to entry: Dispensing and adjusting the distance relative to the well bottom will increase the dispense
height over the course of the dispense. This is an operational mode possible with some ALHS liquid level detection
systems.
3.9
dispensing system
device for delivering liquids from a pre-filled liquid reservoir
3.10
disposable tip
component to transfer liquid, which is attached once and after use, as defined by the manufacturer,
detached and intended to be discarded
Note 1 to entry: Disposable tips are usually made of plastic.
Note 2 to entry: Disposable tips are in contrast to fixed tips (3.13).
3.11
dry contact dispensing
transferring of liquid while the tip is in contact with a dry surface
3.12
factory acceptance testing
internal testing at the site of ALHS production to ensure ALHS performance to manufacturer’s
specifications
3.13
fixed tip
component to transfer liquid, which remains attached to the dispense head after use and is cleaned
prior to its next use
Note 1 to entry: Fixed tips are in contrast to disposable tips (3.10).
3.14
forward mode pipetting
direct mode pipetting
process of liquid transfer where the entire aspirated volume is delivered
3.15
immersion depth
depth of the tip orifice below the liquid surface
Note 1 to entry: Immersion depth can be applied to both aspiration and dispensing (wet contact).
3.16
individually controlled channel
liquid handling channel that can be operated independently of other channels
3.17
inkjet type dispenser
dispensing system which uses technologies that deliver liquid volume as individual, free-flying droplets
or jets (e.g. inkjet technology)
Note 1 to entry: For example, multiple volume increments as small as a few picolitres can be added up to dispense
volumes of several microlitres.
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
3.18
labware
materials used in conjunction with liquid handling operations
Note 1 to entry: Labware includes, but is not limited to, disposable tips, reservoirs, receiving vessels, adapters
and microplates.
3.19
liquid class
specific liquid or liquid type, which is defined by specific liquid characteristics that require specific
settings of the liquid handler to achieve a desired volume delivery
3.20
maximum permissible error
upper or lower permitted extreme value for the deviation of the dispensed volume from the target
volume
3.21
maximum specified volume
largest volume for which specifications are provided
3.22
measured volume
quantity reported by a volume measuring system
Note 1 to entry: In practice, all measurements contain some measurement error. The measured volume is a
quantity value and serves as an estimate of the delivered volume which is not known with complete certainty.
3.23
minimum specified volume
smallest volume for which specifications are provided
3.24
measurement method
measurement procedure
detailed description of a measurement according to one or more measurement principles
Note 1 to entry: Sometimes, a distinction is drawn between a "‘measurement method" and a "measurement
procedure". In this document, the terms are used interchangeably.
Note 2 to entry: The measurement method descriptions in this document detail the steps needed to make a
volume measurement and calculate certain descriptive statistics. Additional details needed to operate the ALHS
are part of the test process (3.51). In this document, the measurement method is one of the components of a test
process.
3.25
measurement uncertainty
non-negative parameter characterizing the statistical dispersion of the delivered
volumes
Note 1 to entry: The measurement uncertainty of the mean delivered volume and the measurement uncertainty
of a single delivered volume are two distinct applications of this concept.
Note 2 to entry: The measurement uncertainty of the mean delivered volume and the measurement uncertainty
of a single delivered volume include contributions from the random errors and uncorrected systematic errors of
the ALHS.
Note 3 to entry: The measurement uncertainty includes contributions from the measuring system uncertainty,
as well as the ALHS under test.
Note 4 to entry: These measurement uncertainties can be estimated according to ISO/IEC Guide 98-3.
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3.26
measuring system uncertainty
non-negative parameter characterizing the statistical dispersion of the volume results of the
measurement procedure, which does not include the uncertainty of the ALHS under test
Note 1 to entry: The measuring system uncertainty can be estimated according to ISO/IEC Guide 98-3.
3.27
metrological confirmation
set of operations required to ensure that the ALHS conforms to the requirements for its intended use
Note 1 to entry: Metrological confirmation generally includes calibration or verification, any necessary
adjustment or repair, and subsequent recalibration, comparison with the metrological requirements for the
intended use of the ALHS, as well as any required sealing and labelling.
Note 2 to entry: Metrological confirmation is not achieved until and unless the fitness of the ALHS for the
intended use has been demonstrated and documented.
Note 3 to entry: The requirements for intended use include such considerations as range, resolution and
maximum permissible errors.
Note 4 to entry: Metrological requirements are usually distinct from, and are not specified in, product
requirements.
[SOURCE: ISO 9000:2015, 3.5.6, modified — the terms ‘measurement equipment’ and ‘equipment’ were
replaced by ‘ALHS.’]
3.28
metrological traceability
traceability
property of a measurement result whereby the result can be related to a reference through a
documented unbroken chain of calibrations, each contributing to the measurement uncertainty
Note 1 to entry: Additional information can be found in the notes to definition (ISO/IEC Guide 99:2007, 2.41) and
the related term ‘metrological traceability chain’ (ISO/IEC Guide 99:2007, 2.42).
[SOURCE: ISO/IEC Guide 99:2007, 2.41, modified — Notes 1 to 4 were deleted and a new Note 1 to entry
was added.]
3.29
microplate
flat plate with an array of wells
[5–9]
Note 1 to entry: Some dimensions of microplates are defined in ANSI/SLAS standards .
3.30
multichannel head
group of liquid handling channels operated in common
Note 1 to entry: Common arrangements of multichannel heads include 8-, 96-, 384-, and 1 536-channel heads.
Other arrangements are possible, e.g. 2-channel to 1 536-channel configurations.
3.31
multi-dispense
repeat dispense
sequential dispense
collection of dispenses without intervening aspiration
Note 1 to entry: First dispense can be different and is frequently wasted.
Note 2 to entry: Repeat dispenses usually dispense repeatedly the same volume, while sequential dispenses
usually dispense different volumes.
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oSIST prEN ISO 23783-1:2023
ISO 23783-1:2022(E)
3.32
non-contact dispensing
contact-free dispensing
free-jet dispensing
dispensing of the liquid without contacting the target or the liquid contained in the target
3.33
outlier
member of a set of values which is inconsistent with the other members of that set
3.34
pipetting system
system for aspirating and dispensing a specified volume of liquid
3.35
positive displacement
direct displacement
liquid handling principle in which a piston is in direct contact with the liquid
3.36
precision
closeness of agreement between replicate delivered volumes under specified conditions
Note 1 to entry: Precision is conceptual and not a quantity value.
Note 2 to entry: Measurement precision is usually expressed numerically by measures of random error, such as
standard deviation, variance, or coefficient of variation under the specified conditions of measurement.
Note 3 to entry: The "specified conditions" can be, for example, repeatability conditions, intermediate precision,
or reproducibility conditions (see ISO 5725-1:1994).
Note 4 to entry: The relationship between accuracy, trueness, precision, systematic error, and random error of an
automated liquid handling system is explained further in ISO 23783-3:2022, 5.1.
3.37
random error
component of liquid handling error that in replicate liquid deliveries varies in an unpredictable
manner
Note 1 to entry: The relationship between accuracy, systematic error, and random error of an automated liquid
handling system is explained further in I
...