Piston-operated volumetric apparatus

Appareils volumétriques à piston

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5060 - Close of voting Proof returned by Secretariat
Completion Date
12-Jan-2022
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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
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/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
---------------------- Page: 1 ----------------------
ISO/FDIS 8655-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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.
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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 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 8655-2, Piston-operated volumetric apparatus — Part 2: Pipettes
ISO 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 volume

ISO 8655-7:— , Piston-operated volumetric apparatus — Part 7: Alternative measurement procedures for

the determination of volume

ISO 8655-8, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement

procedure for the determination of volume

ISO 8655-9, Piston-operated volumetric apparatus — Part 9: Manually operated precision laboratory

syringes
3 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 volume

Note 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.

3.2
balance
〈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 band
3.4
calibration

〈POVA〉 set of operations that establish the relationship between the delivered volume and the

corresponding selected volume of the apparatus with measurement uncertainties

Note 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

3.9
dead 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 cylinder
3.10
evaporation trap

accessory of a balance that minimizes evaporation of test liquid from the weighing vessel

3.11
immersion depth

〈piston pipette〉 depth of the tip orifice of the piston pipette below the liquid surface

© ISO 2021 – All rights reserved
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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 volume

Note 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

volumes

Note 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

3.16
measurement

process of experimentally obtaining one or more quantity values that can be reasonably attributed to a

quantity
3.17
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 used

Note 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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