ISO/FDIS 8655-1
(Main)Piston-operated volumetric apparatus
Piston-operated volumetric apparatus
Appareils volumétriques à piston
General Information
RELATIONS
Standards Content (sample)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 8655-1
ISO/TC 48
Piston-operated volumetric
Secretariat: DIN
apparatus —
Voting begins on:
2021-11-17
Part 1:
Voting terminates on:
Terminology, general requirements
2022-01-12
and user recommendations
Appareils volumétriques à piston —
Partie 1: Définitions, exigences générales et recommandations pour
l'utilisateur
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
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DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 8655-1:2021(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 2021
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ISO/FDIS 8655-1:2021(E)
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© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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© ISO 2021 – All rights reserved
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ISO/FDIS 8655-1:2021(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction .................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ..................................................................................................................................................................................... 1
3 Terms and definitions .................................................................................................................................................................................... 1
4 Abbreviated terms ............................................................................................................................................................................................. 6
5 Types of piston-operated volumetric apparatus ............................................................................................................... 6
5.1 General ........................................................................................................................................................................................................... 6
5.2 Pipettes ......................................................................................................................................................................................................... 6
5.3 Burettes ........................................................................................................................................................................................................ 7
5.4 Dilutors .......................................................................................................................................................................................................... 7
5.5 Dispensers .................................................................................................................................................................................................. 7
5.6 Syringes ........................................................................................................................................................................................................ 7
6 General requirements .................................................................................................................................................................................... 7
6.1 Frequency of calibrations and tests .................................................................................................................................... 7
6.2 Reporting measurement errors .............................................................................................................................................. 7
6.3 Exchangeable Parts ............................................................................................................................................................................ 7
6.4 Metrological confirmation .......................................................................................................................................................... 8
6.5 Routine testing ....................................................................................................................................................................................... 8
6.6 Maintenance and repair ................................................................................................................................................................. 8
6.7 Suitability to give statements on performance ......................................................................................................... 8
6.8 Determination of pass/fail status .......................................................................................................................................... 9
7 Product information ........................................................................................................................................................................................ 9
7.1 User information ................................................................................................................................................................................... 9
7.2 Decontamination and sterilisation ....................................................................................................................................... 9
7.3 Chemical resistance ........................................................................................................................................................................... 9
8 Factors affecting choice of piston-operated volumetric apparatus ..............................................................9
8.1 Interaction with liquids .................................................................................................................................................................. 9
8.2 Use of air displacement pipettes .......................................................................................................................................... 10
9 Marking ........................................................................................................................................... ............................................................................10
Bibliography .............................................................................................................................................................................................................................11
iii© ISO 2021 – All rights reserved
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ISO/FDIS 8655-1:2021(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, in collaboration
with the European Committee for Standardization (CEN) Technical Committee CEN/TC 332, Laboratory
equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).This second edition cancels and replaces the first edition (ISO 8655‐1:2002), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655-1:2002/Cor.1:2008.
The main changes compared to the previous edition are as follows:— ISO 8655-7, ISO 8655-8, and ISO 8655-9 have been added as normative references;
— abbreviated terms have been introduced as Clause 4;— terms and definitions have been revised;
— general requirements for measurement capability and reference measurement have been added
— general requirements for routine testing and maintenance have been added in Clause 6.
A list of all parts in the ISO 8655 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.© ISO 2021 – All rights reserved
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ISO/FDIS 8655-1:2021(E)
Introduction
The ISO 8655 series addresses the needs of:
— manufacturers, as a basis for quality control including, where appropriate, the issuance of
manufacturer’s declarations;— calibration laboratories, test houses, users of the equipment and other bodies as a basis for
independent calibration, testing, verification and routine tests.The tests specified in the ISO 8655 series are intended to be carried out by trained personnel.
For a list of equivalent terms see Annex A.© ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 8655-1:2021(E)
Piston-operated volumetric apparatus —
Part 1:
Terminology, general requirements and user
recommendations
1 Scope
This document specifies general requirements for piston‐operated volumetric apparatus (POVA). It
is applicable to pipettes, burettes, dilutors, dispensers and manually operated precision laboratory
syringes. It furthermore defines terms for the use of piston‐operated volumetric apparatus and gives
user recommendations.This document does not apply to medical products intended for use on humans, e.g. for medical syringes.
2 Normative referencesThe 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 8655-2, Piston-operated volumetric apparatus — Part 2: PipettesISO 8655-3, Piston-operated volumetric apparatus — Part 3: Burettes
ISO 8655-4, Piston-operated volumetric apparatus — Part 4: Dilutors
ISO 8655-5, Piston-operated volumetric apparatus — Part 5: Dispensers
ISO 8655-6, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement
procedure for the determination of volumeISO 8655-7:— , Piston-operated volumetric apparatus — Part 7: Alternative measurement procedures for
the determination of volumeISO 8655-8, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement
procedure for the determination of volumeISO 8655-9, Piston-operated volumetric apparatus — Part 9: Manually operated precision laboratory
syringes3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological 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/
1) Under preparation. Stage at the time of publication: ISO/FDIS 8655-7:2021.
© ISO 2021 – All rights reserved
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ISO/FDIS 8655-1:2021(E)
3.1
adjustment
〈POVA〉 set of operations carried out so that the delivered volume more closely corresponds to the
nominal or selected volumeNote 1 to entry: Information about the correct adjustment method can be found in the manufacturer’s instruction
manual. Some devices have more than one adjustment method. Some have none at all.
3.2balance
〈POVA〉 device to determine the mass of a delivered volume
3.3
bandpass filter
optical filter used to selectively transmit a band of wavelengths from the total spectrum while rejecting
shorter and longer wavelengths than those within the transmission band3.4
calibration
〈POVA〉 set of operations that establish the relationship between the delivered volume and the
corresponding selected volume of the apparatus with measurement uncertaintiesNote 1 to entry: Calibration requires no operation which permanently modifies the apparatus and does not
require adjustment of the device.3.5
coefficient of variation
random error expressed as a percentage of the mean delivered volume
3.6
correction
mathematical compensation of a systematic effect
Note 1 to entry: In the context of this document, a systematic error can be mathematically compensated by
subtracting it from the selected volume.Note 2 to entry: The correction is applied when the user is setting the indication in order to deliver the corrected
intended volume.3.7
chromophore
compound which absorbs photons of a specific energy
3.8
dead air volume
headspace
captive air volume
air cushion
〈air displacement pipettes〉 air volume between the piston and the surface of the liquid in the tip
3.9dead volume
〈POVA〉 amount of liquid which does not belong to the delivered volume and which is contained during
operation in aspiration or expelling tubes, valves and within the cylinder3.10
evaporation trap
accessory of a balance that minimizes evaporation of test liquid from the weighing vessel
3.11immersion depth
〈piston pipette〉 depth of the tip orifice of the piston pipette below the liquid surface
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ISO/FDIS 8655-1:2021(E)
3.12
liquid handling process tolerance
user‐specified tolerance defining the maximum acceptable uncertainty in use of the delivered volume
Note 1 to entry: A POVA is fit for its intended purpose if its uncertainty in use is smaller than or equal to the liquid
handling process tolerance.Note 2 to entry: The liquid handling process tolerance is typically expressed as a percentage of the nominal or
selected volume.3.13
maximum permissible systematic error
permitted extreme value for the deviation of the mean delivered volume from the nominal volume or
selected volumeNote 1 to entry: The maximum permissible systematic errors of piston‐operated volumetric apparatus are
specified in ISO 8655‐2 to ISO 8655‐5, and ISO 8655‐9.3.14
maximum permissible random error
permitted extreme value for the variation of the delivered volumes around the mean of the delivered
volumesNote 1 to entry: The maximum permissible random errors of piston‐operated volumetric apparatus are specified
in ISO 8655-2 to ISO 8655-5 and ISO 8655-9.3.15
mean delivered volume
arithmetic mean of multiple replicate delivered volumes obtained by the measurement method
3.16measurement
process of experimentally obtaining one or more quantity values that can be reasonably attributed to a
quantity3.17
measurement accuracy
accuracy
〈POVA〉 closeness of agreement between delivered volume and the nominal or selected volume
Note 1 to entry: The concept ‘measurement accuracy’ is not given a numerical value. A measurement is said to be
more accurate when is offers a smaller measurement error.Note 2 to entry: The term ‘measurement accuracy’ is not the same as ‘measurement trueness’ or ‘measurement
precision'.3.18
measurement repeatability
measurement precision under a set of repeatability conditions of measurement
3.19
measurement uncertainty
〈volume as delivered by a piston‐operated apparatus〉 non‐negative parameter, associated with the
delivered volume, that characterizes the dispersion of the volumes that could reasonably be attributed
to the delivered volume based on the information usedNote 1 to entry: When POVA are calibrated according to one of the procedures in ISO 8655‐6, ISO 8655‐7, or
ISO 8655‐8, the uncertainty of the mean delivered volume is usually estimated and reported.
Note 2 to entry: When POVA are used in the laboratory the uncertainty in use of a single delivered volume can be
estimated and is discussed further in ISO 8655‐10. This uncertainty is likely to be larger than the uncertainty of
the mean delivered volume.© ISO 2021 – All rights reserved
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ISO/FDIS 8655-1:2021(E)
Note 3 to entry: ISO/TR 20461 and ISO/TR 16153 provide examples of the estimation of the uncertainty of the
mean delivered volume, and the uncertainty in use of a single delivered volume.3.20
measuring system
set of one or more measuring instruments, and often other devices, including any reagents and supplies,
assem...
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