ISO 23783-1:2022 自動化された液体処理システム — Part 1: 用語、語彙および一般要件 | ページ 6

3.1

accuracy

accuracy of liquid delivery

<ALHS> 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.

[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

<piston-operated ALHS> 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

<piston-operated ALHS> 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

<ALHS> 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.

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

<ALHS> 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.

3.18

labware

<ALHS> 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

<delivered volume> 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.

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

Note 1 to entry: Some dimensions of microplates are defined in ANSI/SLAS standards^[5–9].

3.30

multichannel head

<ALHS> 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

<ALHS> 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.

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

<piston-operated ALHS> liquid handling principle in which a piston is in direct contact with the liquid

3.36

precision

<ALHS> 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

<ALHS> 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 ISO 23783-3: 2022, 5.1.

[SOURCE:ISO/IEC Guide 99:2007, 2.19, modified — definition was modified for the context of automated liquid handling; Note 1 was replaced and Notes 2 and 3 were deleted.]

3.38

repeatability

liquid delivery repeatability

<ALHS> precision of liquid deliveries under a set of repeatability conditions

Note 1 to entry: Repeatability refers to the variability among liquid deliveries made on the same automated liquid handling system under nearly identical circumstances. It is recognized that, because of unknown or uncontrollable factors which influence the liquid handling process, repeated measurements will usually not agree. The extent of this variability can be expressed by a standard deviation, called the repeatability standard deviation.

[SOURCE:ISO/IEC Guide 99:2007, 2.21, modified — definition was modified for the context of automated liquid handling and Note 1 was added.]

3.39

repeatability condition

repeatability condition of liquid delivery

<ALHS> condition of liquid delivery, out of a set of conditions that includes the same liquid delivery procedure, same operators, same measuring system, same operating conditions and same location, and replicate measurements on the same automated liquid handling system over a short period of time

[SOURCE:ISO/IEC Guide 99:2007, 2.20, modified — definition was modified for the context of automated liquid handling and Notes 1 and 2 were deleted.]

3.40

reproducibility

precision of liquid deliveries under reproducibility conditions

Note 1 to entry: Reproducibility refers to the variability of replicate volume deliveries by identical ALHS under differing conditions. It includes effects caused by differences among the ALHS and measurement instruments, reagents, operators, laboratories, and environmental conditions. The variability of results under these conditions may be described by a standard deviation, called the reproducibility standard deviation.

[SOURCE:ISO/IEC Guide 99:2007, 2.25, modified — definition was modified for the context of automated liquid handling and Note 1 was replaced.]

3.41

reproducibility condition

reproducibility condition of liquid delivery

<ALHS> condition of liquid delivery that includes different locations, environmental conditions, operators, or automated liquid handling systems

3.42

reservoir

liquid container

<ALHS> vessel that contains the liquid

3.43

reverse mode pipetting

pipetting mode where a volume larger than the target volume is aspirated into the tip and only the target volume is delivered

3.44

single dispense

individual dispense

<ALHS> one liquid delivery per aspiration

3.45

site acceptance testing

in-situ testing at the location where the ALHS will be used, typically a part of the installation process

3.46

supplier’s declaration

<ALHS> document by which a supplier gives written assurance that an ALHS conforms to the requirements of one or more commonly accepted industry standards

3.47

systematic error

<ALHS> component of liquid handling error that in replicate liquid deliveries remains constant or varies in a predictable manner

Note 1 to entry: Systematic error is estimated by calculating the average volume of a series of deliveries and comparing it to the target volume of the automated liquid handling system. Frequently, this result is expressed as a percentage of the target volume.

Note 2 to entry: Systematic liquid handling error, and its causes, can be known or unknown. A correction can be applied to compensate for a known systematic error.

Note 3 to entry: Some ALHS can be adjusted to compensate for a known systematic error.

Note 4 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.

[SOURCE:ISO/IEC Guide 99:2007, 2.17, modified — definition was modified for the context of automated liquid handling; Notes 1 and 3 were replaced and Note 4 was added.]

3.48

system liquid

liquid used to transmit energy between a mechanical actuator and the liquid to be transferred

Note 1 to entry: System liquids can reduce or completely eliminate system dead air volume.

Note 2 to entry: System liquid is usually deionized water. For special applications, organic solvents such as DMSO or aqueous solutions such as saline (e.g. 0,9 % NaCl) can be used.

Note 3 to entry: System liquid can be used for flushing and rinsing tips to minimize cross contamination.

Note 4 to entry: System liquid can be used as a diluent in some applications (e.g. for diluting samples).

3.49

target volume

indicated volume

selected volume

volume which is intended to be delivered

3.50

test liquid

liquid used for the volume measurement

3.51

test process

<ALHS> detailed description of an ALHS testing procedure including system operation and measurement method

Note 1 to entry: The test process includes all details needed to reproduce the test or interpret the results. The measurement method (3.24) is only a part of the test process.

3.52

test report

document reporting the result of the testing

Note 1 to entry: Details regarding information to be contained in test reports are specified in ISO 23783-3: 2022, Clause 6.

3.53

test result

value of a characteristic obtained by carrying out a specified test method

Note 1 to entry: Test result is a broader concept than measured volume. The test result can be a single measured volume, a set of measured volumes, or descriptive statistics such as the mean or standard deviation of multiple measurements.

[SOURCE:ISO 5725-1:1994, 3.2, modified — Note 1 was replaced.]

3.54

trueness

<ALHS> closeness of agreement between the average volume delivered in a large series of deliveries and the target volume

Note 1 to entry: Measurement trueness is not a quantity and thus cannot be expressed numerically, but measures for closeness of agreement are given in ISO 5725-1.

Note 2 to entry: Trueness is inversely related to systematic error but is not related to random error.

Note 3 to entry: The term"accuracy" shall not be used for"trueness".

Note 4 to entry: The relationship between accuracy, precision, trueness, systematic error, and random error of an automated liquid handling system is explained further in ISO 23783-3:2022, 5.1.

[SOURCE:ISO/IEC Guide 99:2007, 2.14, modified — definition was modified for the context of automated liquid handling and Note 4 was added.]

3.55

verification

<ALHS> confirmation, through the provision of objective evidence, that volumetric performance specifications have been fulfilled

Note 1 to entry: The term “verified” is used to designate the corresponding status.

3.56

volume increment

discreetly dispensed volumes which are usually added up to achieve larger delivered volumes

Note 1 to entry: Volume increments can be as small as 11 pl in the case of inkjet-type dispensers.

Note 2 to entry: If it is possible to dispense just one increment, the volume increment equals the lowest possible dispense volume.

3.57

wet contact dispensing

dispensing of the test liquid while the tip is in contact with the liquid present in the target