Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)

This document specifies
—    metrological requirements,
—    maximum permissible errors,
—    requirements for marking and
—    information to be provided for users,
for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.

Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren (ISO 8655-4:2022)

Dieses Dokument trifft Festlegungen hinsichtlich
—   metrologischer Anforderungen,
—   Fehlergrenzen,
—   Anforderungen an die Kennzeichnung und
—   Benutzerinformation
von Dilutoren mit einem Nennvolumen für die Probenaufnahme (In) von 5 µl bis 1 ml und einem Nennvolumen für die Verdünnung (Ex) von 50 µl bis 100 ml. Sie dienen zur gemeinsamen Abgabe der Probe mit der Verdünnungsflüssigkeit in abgemessenem Mengenverhältnis und Volumen.

Appareils volumétriques à piston - Partie 4: Diluteurs (ISO 8655-4:2022)

Le présent document spécifie:
—    les exigences métrologiques;
—    les erreurs maximales tolérées;
—    les exigences relatives au marquage; et
—    les informations à fournir aux utilisateurs;
pour les diluteurs d’une capacité de prélèvement d’échantillon (In) allant de 5 µl à 1 ml et d’une capacité de diluant (Ex) allant de 50 µl à 100 ml. Ceux-ci sont conçus pour distribuer l’échantillon et le diluant ensemble dans une proportion connue et dans un volume mesuré.

Volumetrične naprave, delujoče na bat - 4. del: Razredčevalci (ISO 8655-4:2022)

Ta dokument določa: – meroslovne zahteve; – največje dopustne pogreške; – zahteve za označevanje; in – informacije, predvidene za uporabnike za dilutorje s predelom za zajem vzorca (In) od 5 μl do 1 ml in predelom za redčilo (Ex) od 50 μl to 100 ml. Namenjeni so hkratnemu dovajanju vzorca in redčila z izmerjenim razmerjem in izmerjeno prostornino.

General Information

Status
Published
Public Enquiry End Date
20-Oct-2020
Publication Date
22-May-2022
Technical Committee
I13 - Imaginarni 13
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-May-2022
Due Date
24-Jul-2022
Completion Date
23-May-2022

Relations

Effective Date
18-May-2022
Effective Date
18-May-2022

Overview

EN ISO 8655-4:2022 - "Piston-operated volumetric apparatus - Part 4: Dilutors" specifies metrological requirements, maximum permissible errors, marking and user information for laboratory dilutors. The standard applies to dilutors with a sample uptake capacity (In) of 5 µl to 1 ml and a diluent capacity (Ex) of 50 µl to 100 ml. It replaces the 2002 edition and aligns dilutor testing and documentation with the ISO 8655 series for piston-operated volumetric apparatus.

Key topics and requirements

  • Scope and principle: Defines operation of dilutors that aspirate a measured sample and deliver it together with a measured diluent volume; covers manual, electrical, pneumatic or hydraulic drives and hand‑held, bottle‑top or bench‑top configurations, including automated analyser components.
  • Metrological performance: Requires determination of system trueness and precision using gravimetric methods (total system includes pistons, valves, drive, uptake/delivery probe, tubing and any change‑over unit).
  • Maximum permissible errors (MPEs): Tables list MPEs for nominal volumes; the standard also gives a formula to calculate MPEs for selected volumes:
    • e_Vs = (V_nom / V_s) × e_Vnom
    • Values do not apply below 10% of nominal volume; calculated MPEs are capped at 25%.
  • Adjustment: Specifies initial and subsequent adjustment procedures and reference conditions (standard reference temperature 20 °C or 27 °C, 50% RH, 101.3 kPa, using grade 3 water per ISO 3696).
  • Marking and user information: Requires clear marking and detailed manufacturer instructions, including evidence and records when subsequent adjustments are performed.
  • Testing references: Measurement and verification by ISO 8655-6 (gravimetric reference procedure) or ISO 8655-7 (alternative procedures).

Practical applications and users

EN ISO 8655-4:2022 is intended for:

  • Manufacturers - product design, quality control and performance declarations for dilutors.
  • Calibration laboratories and test houses - to perform verification, calibration and routine checks using standardized gravimetric methods.
  • Clinical, pharmaceutical and research laboratories - to select and validate dilutors for sample preparation, serial dilution and automated workflows.
  • Regulatory and QA teams - to ensure documented compliance of volumetric dilutor equipment.

Adoption of this standard helps ensure accurate, traceable dilution steps, reduce assay variability and support compliance in laboratory workflows.

Related standards

  • ISO 8655-1 - Terminology, general requirements and user recommendations
  • ISO 8655-6 - Gravimetric reference measurement procedure for determination of volume
  • ISO 8655-7 - Alternative measurement procedures for determination of volume

Keywords: EN ISO 8655-4:2022, dilutors, piston-operated volumetric apparatus, metrological requirements, maximum permissible errors, gravimetric measurement, calibration, laboratory equipment.

Standard

SIST EN ISO 8655-4:2022

English language
14 pages
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Frequently Asked Questions

SIST EN ISO 8655-4:2022 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)". This standard covers: This document specifies —    metrological requirements, —    maximum permissible errors, —    requirements for marking and —    information to be provided for users, for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.

This document specifies —    metrological requirements, —    maximum permissible errors, —    requirements for marking and —    information to be provided for users, for dilutors with a sample uptake capacity (In) from 5 μl to 1 ml and a diluent capacity (Ex) from 50 μl to 100 ml. They are designed to deliver the sample and diluent together in measured proportion and measured volume.

SIST EN ISO 8655-4:2022 is classified under the following ICS (International Classification for Standards) categories: 17.060 - Measurement of volume, mass, density, viscosity; 71.040.20 - Laboratory ware and related apparatus. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN ISO 8655-4:2022 has the following relationships with other standards: It is inter standard links to SIST EN ISO 8655-4:2002, SIST EN ISO 8655-4:2002/AC:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase SIST EN ISO 8655-4:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-julij-2022
Nadomešča:
SIST EN ISO 8655-4:2002
SIST EN ISO 8655-4:2002/AC:2009
Volumetrične naprave, delujoče na bat - 4. del: Razredčevalci (ISO 8655-4:2022)
Piston-operated volumetric apparatus - Part 4: Dilutors (ISO 8655-4:2022)
Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren (ISO 8655-4:2022)
Appareils volumétriques à piston - Partie 4: Diluteurs (ISO 8655-4:2022)
Ta slovenski standard je istoveten z: EN ISO 8655-4:2022
ICS:
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 8655-4
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2022
EUROPÄISCHE NORM
ICS 17.060 Supersedes EN ISO 8655-4:2002, EN ISO 8655-
4:2002/AC:2009
English Version
Piston-operated volumetric apparatus - Part 4: Dilutors
(ISO 8655-4:2022)
Appareils volumétriques à piston - Partie 4: Diluteurs Volumenmessgeräte mit Hubkolben - Teil 4: Dilutoren
(ISO 8655-4:2022) (ISO 8655-4:2022)
This European Standard was approved by CEN on 13 February 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8655-4:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8655-4:2022) has been prepared by Technical Committee ISO/TC 48
"Laboratory equipment" in collaboration with Technical Committee CEN/TC 332 “Laboratory
equipment” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2022, and conflicting national standards
shall be withdrawn at the latest by November 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8655-4:2002.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8655-4:2022 has been approved by CEN as EN ISO 8655-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 8655-4
Second edition
2022-04
Piston-operated volumetric
apparatus —
Part 4:
Dilutors
Appareils volumétriques à piston —
Partie 4: Diluteurs
Reference number
ISO 8655-4:2022(E)
ISO 8655-4:2022(E)
© 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
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 8655-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle of operation . 1
5 Adjustment .2
5.1 Basis of adjustment . 2
5.2 Initial adjustment . 2
5.3 Subsequent adjustment . 2
6 Metrological performance requirements . 3
6.1 General . 3
6.2 Calculation of maximum permissible errors not given in Tables 1 and 2 . 3
7 User information . 5
8 Marking . . 6
iii
ISO 8655-4:2022(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, 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 8655-4:2002), which has been technically
revised. It also incorporates the Technical Corrigendum ISO 8655-4:2002/Cor.1:2008.
The main changes are as follows:
— ISO 8655-7 has been added as a normative reference;
— Tables 1 and 2 have been revised.
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 2
...

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