prEN ISO 18113-3

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)

Decision BT C87/2011 (extension of DOW): DOW = DAV + 36 months

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3: Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal (ISO/DIS 18113-3:2021)

Dieses Dokument legt Anforderungen an die durch den Hersteller von IVD-Geräten für den Gebrauch durch Fachpersonal bereitgestellten Informationen fest.
Dieses Dokument gilt auch für Geräte und Ausrüstungen, die für den Gebrauch zusammen mit IVD-Geräten für den Gebrauch durch Fachpersonal vorgesehen sind.
Dieses Dokument kann auch auf Zubehör angewendet werden.
Dieses Dokument gilt nicht für:
a) Anweisungen für die Geräteinstandhaltung oder -reparatur;
b) IVD-Reagenzien, einschließlich Kalibriermaterialien und Kontrollmaterialien zur Kontrolle des Reagenz;
c) IVD-Geräte zur Eigenanwendung.

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO/DIS 18113-3:2021)

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 3. del: Diagnostični instrumenti in vitro za poklicno uporabo (ISO/DIS 18113-3:2021)

General Information

• Status: Not Published
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Due Date: 14-Apr-2022
• Completion Date: 14-Apr-2022
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/481 - Mandate to CEN, CENELEC and ETSI for Standardisation in the fieid of household dishwasher
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 18113-3:2021 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)

RELATIONS

• Revised: EN ISO 18113-3:2011 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
• Effective Date: 27-Nov-2019

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 18113-3:2021
01-oktober-2021

In vitro diagnostični preskusni sistemi - Informacije proizvajalca (označevanje) - 3.

del: Diagnostični instrumenti in vitro za poklicno uporabo (ISO/DIS 18113-3:2021)

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)

- Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)

In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller - Teil 3:

Geräte für in-vitro-diagnostische Untersuchungen zum Gebrauch durch Fachpersonal
(ISO/DIS 18113-3:2021)

Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant

(étiquetage) - Partie 3: Instruments de diagnostic in vitro à usage professionnel (ISO/DIS

18113-3:2021)
Ta slovenski standard je istoveten z: prEN ISO 18113-3
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
oSIST prEN ISO 18113-3:2021 en,fr,de

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

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oSIST prEN ISO 18113-3:2021
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oSIST prEN ISO 18113-3:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 18113-3
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-08-02 2021-10-25
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 3:
In vitro diagnostic instruments for professional use

Dispositifs médicaux de diagnostic in vitro — Informations fournies par le fabricant (étiquetage) —

Partie 3: Instruments de diagnostic in vitro à usage professionnel
ICS: 11.100.10
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
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 18113-3:2021(E)
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 SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 18113-3:2021
ISO/DIS 18113-3:2021(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.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
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oSIST prEN ISO 18113-3:2021
ISO/DIS 18113-3:2021(E)
Contents Page

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

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

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

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

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

4 Essential requirements ................................................................................................................................................................................. 2

5 Labels and marking ........................................................................................................................................................................................... 2

5.1 General ........................................................................................................................................................................................................... 2

5.2 Identification of the IVD instrument .................................................................................................................................... 2

5.2.1 IVD instrument name .................................................................................................................................................. 2

5.2.2 Serial number ..................................................................................................................................................................... 2

5.2.3 In vitro diagnostic use ................................................................................................................................................. 2

5.2.4 Unique device identifier/indentification (UDI) .................................................................................... 3

6 Elements of the instructions for use ................................................................................................................................................ 3

7 Content of the instructions for use .................................................................................................................................................... 4

7.1 Manufacturer ............................................................................................................................................................................................ 4

7.2 Identification of the IVD instrument .................................................................................................................................... 4

7.2.1 IVD instrument name .................................................................................................................................................. 4

7.2.2 Module and software identification ................................................................................................................ 4

7.3 Intended use/Intended purpose ............................................................................................................................................. 4

7.4 Storage and handling ......................................................................................................................................................................... 5

7.5 Warnings and precautions and/or measures to be taken and limitations of use

regarding the instrument ............................................................................................................................................................... 5

7.6 Instrument installation .................................................................................................................................................................... 5

7.6.1 General...................................................................................................................................................................................... 5

7.6.2 Action upon delivery .................................................................................................................................................... 6

7.6.3 Site preparation prior to installation ............................................................................................................. 6

7.6.4 Bringing into operation .............................................................................................................................................. 6

7.7 Theory of operation ............................................................................................................................................................................ 6

7.8 Functions ...................................................................................................................................................................................................... 7

7.9 Limitations .................................................................................................................................................................................................. 7

7.10 Preparation prior to operation ................................................................................................................................................. 7

7.11 Operating procedure .......................................................................................................................................................................... 7

7.12 Control procedure ................................................................................................................................................................................ 7

7.13 Calculation of examination results ........................................................................................................................................ 8

7.14 Special functions .................................................................................................................................................................................... 8

7.15 Emergency primary samples ...................................................................................................................................................... 8

7.16 Shut-down procedure ....................................................................................................................................................................... 8

7.17 Disposal information ......................................................................................................................................................................... 8

7.18 Maintenance .............................................................................................................................................................................................. 9

7.19 Troubleshooting ..................................................................................................................................................................................... 9

7.20 Document control ................................................................................................................................................................................. 9

Bibliography .............................................................................................................................................................................................................................10

© ISO 2021 – All rights reserved iii
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oSIST prEN ISO 18113-3:2021
ISO/DIS 18113-3:2021(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 212, Clinical laboratory testing and in

vitro diagnostic test systems.

This second edition cancels and replaces the first edition (ISO 18113:2009), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— Updated text to reflect changes in regulations and provide examples for clarity

— Added Information pertaining to UDI (Unique Device Identifier/Identification)
— Updated bibliography

In this document, the following verbal forms are used: — “shall” indicates a requirement; — “should”

indicates a recommendation; — “may” indicates a permission; — “can” indicates a possibility or a

capability. Information marked as “NOTE” is for guidance in understanding or clarifying the associated

requirement.
A list of all parts in the ISO 18113 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 2021 – All rights reserved
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oSIST prEN ISO 18113-3:2021
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Introduction

Manufacturers of in vitro diagnostic (IVD) instruments for professional use supply users with

information to enable the safe use and expected performance of their devices according to the intended

use. The type and level of detail varies according to the intended uses and country-specific regulations.

The International Medical Device Regulators Forum (IMDRF) encourages convergence of the evolution

of regulatory systems for medical devices at the global level. Eliminating differences among regulatory

jurisdictions could allow patients earlier access to new technologies and treatments. This document

provides a basis for harmonization of labelling requirements for IVD instruments for professional use.

This document is concerned solely with information supplied with IVD instruments and equipment

intended for professional use. It is intended to be used in conjunction with ISO 18113-1, which contains

the general requirements for information supplied by the manufacturer and definitions of general

labelling concepts.

This document is intended to support the essential labelling requirements of all the IMDRF [6] partners,

as well as other countries that have or plan to enact labelling regulations for IVD medical devices.

For IVD instruments for professional use that are intended to be used as a system with reagents provided

by the same manufacturer, this document is also intended to be used together with ISO 18113-1 and

ISO 18113-2.
© ISO 2021 – All rights reserved v
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oSIST prEN ISO 18113-3:2021
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oSIST prEN ISO 18113-3:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 18113-3:2021(E)
In vitro diagnostic medical devices — Information supplied
by the manufacturer (labelling) —
Part 3:
In vitro diagnostic instruments for professional use
1 Scope

This document specifies requirements for information supplied by the manufacturer of IVD instruments

intended for professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for

professional use.
This document can also be applied to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;

b) IVD reagents, including calibrators and control materials for use in control of the reagent;

c) IVD instruments for self-testing.
2 Normative references

The following referenced documents are indispensable for the application 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 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 18113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) —

Part 1: Terms, definitions and general requirements

IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use —

Part 1: General requirements

IEC 61010-2-101, Safety requirements for electrical equipment for measurement, control and laboratory

use — Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61326-2-6, Electrical equipment for measurement, control and laboratory use — EMC requirements —

Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment

IEC 62366, Medical devices — Application of usability engineering to medical devices

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 18113-1 apply.

© ISO 2021 – All rights reserved 1
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oSIST prEN ISO 18113-3:2021
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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 https:// www .electropedia .org/
4 Essential requirements
The requirements of ISO 18113-1 apply.
5 Labels and marking
5.1 General
The requirements of IEC 61010-1, IEC 61010-2-101 and IEC 61326-2-6 conc
...