Piston-operated volumetric apparatus - Part 1: Terminology, general requirements and user recommendations (ISO/DIS 8655-1:2020)

Volumenmessgeräte mit Hubkolben - Teil 1: Begriffe, allgemeine Anforderungen und Gebrauchsempfehlungen (ISO/DIS 8655-1:2020)

Dieser Teil von ISO 8655 legt die allgemeinen Anforderungen an Volumenmessgeräte mit HubkolbenN1) fest. Er gilt für Pipetten, Büretten, Dilutoren und Dispenser sowie manuell betätigte Präzisionslaborspritzen. Er definiert des Weiteren Begriffe für den Gebrauch von Kolbenhubgeräten und gibt Gebrauchsempfehlungen.
ISO 8655 gilt nicht für Medizinprodukte zur Anwendung am Menschen, z. B. für medizinische Spritzen.
ANMERKUNG Hinsichtlich der messtechnischen Anforderungen, der Fehlergrenzen sowie der Anforderungen an Kennzeichnung und Nutzerinformation siehe ISO 8655-2 für Pipetten, ISO 8655-3 für Büretten, ISO 8655-4 für Dilutoren, ISO 8655-5 für Dispenser und ISO 8655-9 für manuell betätigte Präzisionslaborspritzen. Das gravimetrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-6 angegeben. Das photometrische Referenzmessverfahren für die Volumenbestimmung ist in ISO 8655-8 angegeben. Alternative Messverfahren für die Volumenbestimmung werden in ISO 8655-7 beschrieben.

Appareils volumétriques à piston - Partie 1: Définitions, exigences générales et recommandations pour l'utilisateur (ISO/DIS 8655-1:2020)

Volumetrične naprave, delujoče na bat - 1. del: Terminologija, splošne zahteve in priporočila za uporabnike (ISO/DIS 8655-1:2020)

General Information

Status
Not Published
Public Enquiry End Date
20-Oct-2020
Technical Committee
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
24-Nov-2021
Due Date
12-Jan-2022

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SLOVENSKI STANDARD
oSIST prEN ISO 8655-1:2020
01-oktober-2020

Volumetrične naprave, delujoče na bat - 1. del: Terminologija, splošne zahteve in

priporočila za uporabnike (ISO/DIS 8655-1:2020)

Piston-operated volumetric apparatus - Part 1: Terminology, general requirements and

user recommendations (ISO/DIS 8655-1:2020)
Volumenmessgeräte mit Hubkolben - Teil 1: Begriffe, allgemeine Anforderungen und
Gebrauchsempfehlungen (ISO/DIS 8655-1:2020)
Appareils volumétriques à piston - Partie 1: Définitions, exigences générales et
recommandations pour l'utilisateur (ISO/DIS 8655-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 8655-1
ICS:
01.040.17 Meroslovje in merjenje. Metrology and measurement.
Fizikalni pojavi (Slovarji) Physical phenomena
(Vocabularies)
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
oSIST prEN ISO 8655-1:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 8655-1:2020
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oSIST prEN ISO 8655-1:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 8655-1
ISO/TC 48 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-07-29 2020-10-21
Piston-operated volumetric apparatus —
Part 1:
Terminology, general requirements and user
recommendations
Appareils volumétriques à piston —
Partie 1: Définitions, exigences générales et recommandations pour l'utilisateur
ICS: 17.060; 01.040.17
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
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STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 8655-1:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 8655-1:2020
ISO/DIS 8655-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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

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ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 8655-1:2020
ISO/DIS 8655-1:2020(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Abbreviated Terms ............................................................................................................................................................................................. 7

5 Types of piston-operated volumetric apparatus ................................................................................................................. 8

5.1 General ........................................................................................................................................................................................................... 8

5.2 Pipettes .......................................................................................................................................................................................................... 8

5.3 Burettes ......................................................................................................................................................................................................... 8

5.4 Dilutors .......................................................................................................................................................................................................... 8

5.5 Dispensers .................................................................................................................................................................................................. 8

5.6 Syringes ......................................................................................................................................................................................................... 8

6 General requirements ..................................................................................................................................................................................... 8

6.1 Reference measurement procedures ................................................................................................................................... 8

6.2 Suitability to give statements on performance ........................................................................................................... 9

6.3 Reporting measurement errors ................................................................................................................................................ 9

6.4 Test frequency ......................................................................................................................................................................................... 9

6.5 Exchangeable Parts ............................................................................................................................................................................. 9

7 Routine testing ....................................................................................................................................................................................................... 9

8 Determination of pass/fail status ....................................................................................................................................................10

9 Product information ......................................................................................................................................................................................10

9.1 User information ................................................................................................................................................................................10

9.2 Decontamination ................................................................................................................................................................................10

9.3 Chemical resistance .........................................................................................................................................................................10

10 Factors affecting choice of piston-operated volumetric apparatus ..............................................................11

10.1 Interaction with liquids ................................................................................................................................................................11

10.2 Use of air displacement pipettes ..........................................................................................................................................11

11 Marking .......................................................................................................................................................................................................................11

Annex A (informative) List of equivalent terms .....................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................13

© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 8655-1:2020
ISO/DIS 8655-1:2020(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 on 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 the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 48, Laboratory Equipment, Working

Group WG 4, Piston-operated instruments.

This second edition cancels and replaces the first edition (ISO 8655‐1:2002 and ISO 8655‐1:2002/Cor

1:2008), which has been technically revised.
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 a 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.

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.
iv © ISO 2020 – All rights reserved
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Introduction
ISO 8655 addresses the needs of:

— manufacturers, as a basis for quality control including, where appropriate, the issuance of

manufacturers' declarations;

— calibration laboratories, test houses, users of the equipment and other bodies as a basis for

independent calibration, certification and routine checking.

The tests specified in the ISO 8655 series are intended to be carried out by trained personnel.

© ISO 2020 – All rights reserved v
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oSIST prEN ISO 8655-1:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 8655-1:2020(E)
Piston-operated volumetric apparatus —
Part 1:
Terminology, general requirements and user
recommendations
1 Scope

This part of ISO 8655 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.

ISO 8655 is not applicable to medical products intended for use on humans, e.g. for medical syringes.

NOTE For the metrological requirements, maximum permissible errors, requirements for marking and

information to be provided for users of piston-operated volumetric apparatus, see ISO 8655-2 for pipettes,

see ISO 8655-3 for burettes, see ISO 8655-4 for dilutors, see ISO 8655-5 for dispensers, and see ISO 8655-9 for

manually operated precision laboratory syringes. The gravimetric reference measurement procedure for the

determination of volume is given in ISO 8655-6. The photometric reference measurement procedure for the

determination of volume is given in ISO 8655-8. Alternative measurement procedures for the determination of

volume are described in ISO 8655-7.
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 8655-2:2020, Piston-operated volumetric apparatus — Part 2: Pipettes
ISO 8655-3:2020, Piston-operated volumetric apparatus — Part 3: Burettes
ISO 8655-4:2020, Piston-operated volumetric apparatus — Part 4: Dilutors
ISO 8655-5:2020, Piston-operated volumetric apparatus — Part 5: Dispensers

ISO 8655-6:2020, Piston-operated volumetric apparatus — Part 6: Gravimetric reference measurement

procedure for the determination of volume

ISO 8655-7:2020, Piston-operated volumetric apparatus — Part 7: Alternative measurement procedures

for the determination of volume

ISO 8655-8:2020, Piston-operated volumetric apparatus — Part 8: Photometric reference measurement

procedure for the determination of volume

ISO 8655-9:2020, 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.
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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 http:// www .electropedia .org/
3.1
absorbance drift

change in measured absorbance at a specific wavelength over time due to photometer characteristics

3.2
accuracy of measurement

〈piston‐operated volumetric apparatus〉 closeness of agreement between delivered volume and the

nominal or selected volume

Note 1 to entry: The concept ‘accuracy’ is not given a numerical value. Accuracy is a combination of trueness and

precision and can be assessed with both the systematic error and the random error and will be affected by both.

Note 2 to entry: The term ‘accuracy’ is not the same as ‘trueness”.

Note 3 to entry: The measurement uncertainty of a single delivered volume is used to quantitatively express the

accuracy of a measurement.

[SOURCE: ISO/IEC Guide 99: 2007, 2.13, modified for the purpose of the POVA standard]

3.3
adjustment

〈piston‐operated volumetric apparatus〉 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.

[SOURCE: ISO/IEC Guide 99: 2007, 3.11, modified for the purpose of the POVA standard]

3.4
balance

〈piston‐operated volumetric apparatus〉 device to determine the mass of a delivered volume

Note 1 to entry: An analytical balance is a balance that has a readability of 0.1 mg or smaller.

Note 2 to entry: The readability is the smallest difference in mass that can be read on the balance.

3.5
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
3.6
baseline drift
photometric drift
photometric stability
change in the baseline absorbance at a specific wavelength over time

Note 1 to entry: Temperature fluctuations can influence the photometric stability.

3.7
baseline flatness

measure of the photometer’s ability to compensate for inherent optical and electronic noise across the

wavelength range of interest without any sample in the sample compartment
2 © ISO 2020 – All rights reserved
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3.8
calibration

〈piston‐operated volumetric apparatus〉 set of operations that establish the relationship between

the delivered volume and the corresponding nominal or 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.

[SOURCE: ISO/IEC Guide 99: 2007, 2.39, modified for the purpose of the POVA standard]

3.9
coefficient of variation
the random error expressed as a percentage of the mean delivered volume
3.10
correction
mathematical compensation of a systematic effect

Note 1 to entry: In the context of this standard, a systematic error can be mathematically compensated by

subtracting the systematic error from the measured value.

Note 2 to entry: The correction is applied when the user is setting the indication in order to deliver the corrected

intended volume.

[SOURCE: ISO/IEC Guide 99: 2007, 2.53, modified for the purpose of the POVA standard]

3.11
chromophore
compound which absorbs photons of a specific energy
3.12
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

3.13
dead liquid volume

〈piston‐operated volumetric apparatus〉 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

3.14
evaporation trap

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

3.15
immersion depth

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

3.16
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.
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3.17
maximum permissible systematic error

permitted extreme value for the deviation of the mean delivered volume from the nominal volume (3.27)

or selected volume (3.34)

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.

[SOURCE: ISO/IEC Guide 99:2007, 4.26, modified for the purpose of the POVA standard]

3.18
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.

[SOURCE: ISO/IEC Guide 99:2007, 4.26, modified for the purpose of the POVA standard]

3.19
mean delivered volume

arithmetic mean of multiple replicate delivered volumes obtained by the measurement method

3.20
measurement

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

quantity
[SOURCE: ISO/IEC Guide 99:2007, 2.1]
3.21
measurement repeatability
measurement precision under a set of repeatability conditions of measurement
[SOURCE: ISO/IEC Guide 99:2007, 2.21]
3.22
measurement uncertainty

〈volume 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: There are two distinct types of measureme
...

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