Good refurbishment practices for medical imaging equipment

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: – X-RAY EQUIPMENT; – X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; – X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; – MAGNETIC RESONANCE EQUIPMENT; – ULTRASONIC DIAGNOSTIC EQUIPMENT; – GAMMA CAMERAS; – PLANAR WHOLEBODY IMAGING EQUIPMENT; – equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); – SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – POSITRON EMISSION TOMOGRAPHS (PET); – PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and – other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems. IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016: a) the scope was delineated more clearly; b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added; c) smaller corrections were performed.

Sachgemäße Verfahren zur Aufarbeitung von medizinischen bildgebenden Geräten

Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale

L'IEC 63077:2019 décrit et définit le PROCESSUS de RECONDITIONNEMENT des APPAREILS D’IMAGERIE MEDICALE USAGES et s’applique à redonner aux APPAREILS D’IMAGERIE MEDICALE USAGES une condition de sécurité et de performances comparable à celle d’un appareil neuf, c’est-à-dire un APPAREIL D’IMAGERIE MEDICALE qui n’a pas été utilisé. Cette restauration inclut des actions telles que la REPARATION, la RETOUCHE, les mises à jour logiciel/matériel ainsi que le remplacement des pièces usagées par des pièces d’origine. Le présent document énumère les actions qui sont réalisées en cohérence avec les spécifications et les procédures d’entretien applicables, exigées pour garantir que le RECONDITIONNEMENT d’un APPAREIL D’IMAGERIE MEDICALE est effectué sans modification des performances de l’APPAREIL D’IMAGERIE MÉDICALE fini, des spécifications de sécurité ni de l’UTILISATION PREVUE selon son enregistrement valide d’origine ou applicable. Les APPAREILS et systèmes D’IMAGERIE MEDICALE couverts par le présent document incluent les éléments suivants: – APPAREILS À RAYONNEMENT X; – APPAREILS A RAYONNEMENT X pour INTERVENTIONS GUIDEES PAR RADIOSCOPIE; – APPAREILS A RAYONNEMENT X POUR TOMODENSITOMETRIE; – APPAREILS À RÉSONANCE MAGNÉTIQUE; – APPAREILS DE DIAGNOSTIC A ULTRASONS; – CAMÉRAS GAMMA; – EQUIPEMENTS D’IMAGERIE PLANAIRE DU CORPS ENTIER; – appareils pour TOMODENSITOMETRIE PAR EMISSION DE PHOTONS SIMPLES (SPECT); – systèmes hybrides SPECT/CT, combinant une CAMERA GAMMA et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – TOMOGRAPHES A EMISSION DE POSITRONS (PET); – systèmes hybrides SPECT/CT combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un EQUIPEMENT A RAYONNEMENT X POUR TOMODENSITOMETRIE (CT); – systèmes hybrides PET/MRI combinant un TOMOGRAPHE A EMISSION DE POSITRONS et un APPAREIL A RESONANCE MAGNETIQUE: et – autres combinaisons des APPAREILS ou systèmes énumérés ci-dessus. Le présent document ne s’applique pas aux appareils d’endoscopie, aux appareils pour fond d’œil, aux appareils de radiothérapie ni aux systèmes associés. L'IEC 63077:2019 inclut les modifications techniques majeures suivantes par rapport à l'édition précédente: a) le domaine d'application a été défini plus précisément; b) une liste informative des références croisées du contenu de l'IEC 63077 en regard de l'ISO 13485 a été ajoutée (Annexe A); c) de petites corrections ont été faites.

Dobre prakse za obnovo medicinske opreme za slikanje (IEC 63077:2019)

Ta dokument opisuje in opredeljuje PROCES OBNOVE UPORABLJENE MEDICINSKE OPREME ZA SLIKANJE in se navezuje na obnovo UPORABLJENE MEDICINSKE OPREME ZA SLIKANJE do stanja varnosti in učinkovitosti, ki je primerljivo z novo MEDICINSKO OPREMO ZA SLIKANJE, tj. MEDICINSKO OPREMO ZA SLIKANJE, ki še ni bila uporabljena. Ta obnova vključuje ukrepe, kot so POPRAVILO, PREDELAVA, posodobitve programske/strojne opreme in zamenjava dotrajanih delov z originalnimi deli. Ta dokument našteva izvedene ukrepe in način, skladen z ustreznimi specifikacijami in servisnimi postopki, potrebnimi za zagotovitev, da se OBNOVA MEDICINSKE OPREME ZA SLIKANJE izvede brez spreminjanja zmogljivosti, varnostnih specifikacij ali NAMENA UPORABE končne MEDICINSKE OPREME ZA SLIKANJE v skladu z zahtevami izvirne ali trenutno veljavne registracije. MEDICINSKA OPREMA ZA SLIKANJE in sistemi, ki jih zajema ta dokument, so: – RENTGENSKA OPREMA; – RENTGENSKA OPREMA za RADIOSKOPSKO VODENE INTERVENCIJSKE POSTOPKE; – RENTGENSKA OPREMA ZA RAČUNALNIŠKO TOMOGRAFIJO; – MAGNETNO RESONANČNA OPREMA; – ULTRAZVOČNA DIAGNOSTIČNA OPREMA; – GAMA KAMERE; – OPREMA ZA PLANARNO SLIKANJE CELOTNEGA TELESA; – oprema za RAČUNALNIŠKO TOMOGRAFIJO Z ENIM FOTONOM (SPECT); – hibridni sistemi SPECT/CT, ki združujejo GAMA KAMERO z RENTGENSKO OPREMO ZA RAČUNALNIŠKO TOMOGRAFIJO (CT); – POZITRONSKA EMISIJSKA TOMOGRAFIJA (PET); – hibridni sistemi PET/CT, ki združujejo POZITRONSKO EMISIJSKO TOMOGRAFIJO z RENTGENSKO OPREMO ZA RAČUNALNIŠKO TOMOGRAFIJO (CT); – hibridni sistemi PET/MRI, ki združujejo POZITRONSKO EMISIJSKO TOMOGRAFIJO in OPREMO ZA MAGNETNO RESONANCO; in – druge kombinacije zgoraj navedene MEDICINSKE OPREME ZA SLIKANJE ali sistemov. Ta dokument se ne uporablja za endoskopsko opremo, funduskopsko opremo, opremo za sevalno terapijo ter povezane sisteme

General Information

Status
Published
Publication Date
19-Dec-2019
Current Stage
6060 - Document made available
Due Date
20-Dec-2019
Completion Date
20-Dec-2019

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SLOVENSKI STANDARD
SIST EN IEC 63077:2020
01-marec-2020
Dobre prakse za obnovo medicinske opreme za slikanje (IEC 63077:2019)
Good refurbishment practices for medical imaging equipment (IEC 63077:2019)

Sachgemäße Verfahren zur Aufarbeitung von medizinischen bildgebenden Geräten (IEC

63077:2019)

Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale (IEC

63077:2019)
Ta slovenski standard je istoveten z: EN IEC 63077:2019
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
SIST EN IEC 63077:2020 en

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

---------------------- Page: 1 ----------------------
SIST EN IEC 63077:2020
---------------------- Page: 2 ----------------------
SIST EN IEC 63077:2020
EUROPEAN STANDARD EN IEC 63077
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2019
ICS 11.040.55
English Version
Good refurbishment practices for medical imaging equipment
(IEC 63077:2019)

Bonnes pratiques de reconditionnement pour les appareils Sachgemäße Verfahren zur Aufarbeitung von

d'imagerie médicale medizinischen bildgebenden Geräten
(IEC 63077:2019) (IEC 63077:2019)

This European Standard was approved by CENELEC on 2019-12-18. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN IEC 63077:2019 E
---------------------- Page: 3 ----------------------
SIST EN IEC 63077:2020
EN IEC 63077:2019 (E)
European foreword

The text of document 62B/1149/FDIS, future edition 1 of IEC 63077, prepared by SC 62B "Diagnostic

imaging equipment" of IEC/TC 62 "Electrical equipment in medical practice" was submitted to the IEC-

CENELEC parallel vote and approved by CENELEC as EN IEC 63077:2019.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2020-09-18

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2022-12-18

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 63077:2019 was approved by CENELEC as a European

Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified)
IEC 62353:2014 NOTE Harmonized as EN 62353:2014 (not modified)
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SIST EN IEC 63077:2020
EN IEC 63077:2019 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

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.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:

www.cenelec.eu.
Publication Year Title EN/HD Year
ISO 13485 - Medical devices -- Quality management EN ISO 13485 2016
systems -- Requirements for regulatory
purposes
- - + AC 2018
ISO 14971 2007 Medical devices_- Application of risk - -
management to medical devices
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SIST EN IEC 63077:2020
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SIST EN IEC 63077:2020
IEC 63077
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Good refurbishment practices for medical imaging equipment
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-7595-5

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 7 ----------------------
SIST EN IEC 63077:2020
– 2 – IEC 63077:2019 © IEC 2019
CONTENTS

FOREWORD ........................................................................................................................... 3

INTRODUCTION ..................................................................................................................... 5

1 Scope .............................................................................................................................. 6

2 Normative references ...................................................................................................... 6

3 Terms and definitions ...................................................................................................... 7

4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT ................ 9

4.1 Quality management system ................................................................................... 9

4.2 Resource management ........................................................................................... 9

4.3 Corrective and preventive action ............................................................................. 9

4.4 Customer complaints .............................................................................................. 9

4.5 Production and service provision ............................................................................ 9

4.6 Control of nonconforming PRODUCT ....................................................................... 10

4.7 Post-market surveillance PROCESS ........................................................................ 10

4.8 Document control .................................................................................................. 10

4.9 Purchasing ............................................................................................................ 10

4.10 Control of design and design changes .................................................................. 10

4.11 RISK management PROCESS ................................................................................... 10

5 Specific requirements for good REFURBISHMENT practice ................................................ 11

5.1 General ................................................................................................................. 11

5.2 Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT ................................. 11

5.3 Evaluating market access requirements ................................................................ 11

5.4 Preparation for REFURBISHMENT, disassembly, packing, and transport ................... 11

5.5 Planning ............................................................................................................... 11

5.6 Installation of software and hardware to ensure the safety of the MEDICAL

IMAGING EQUIPMENT ................................................................................................ 12

5.7 Performance and safety test ................................................................................. 12

5.8 Packing, transport, and installation of refurbished MEDICAL IMAGING

EQUIPMENT............................................................................................................. 12

5.9 Record of REFURBISHMENT ..................................................................................... 12

5.10 REFURBISHMENT label ............................................................................................ 12

Annex A (informative) Cross reference list of the contents of IEC 63077 versus

ISO 13485 ..................................................................................................................... 13

Bibliography .......................................................................................................................... 15

Index of defined terms used in this document ....................................................................... 16

Table A.1 – Cross reference list of the contents of IEC 63077 versus ISO 13485 .................. 13

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SIST EN IEC 63077:2020
IEC 63077:2019 © IEC 2019 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 63077 has been prepared by subcommittee 62B: Diagnostic

imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.

This first edition cancels and replaces the second edition of IEC PAS 63077 published in 2016.

This edition constitutes a technical revision.

This edition includes the following significant technical changes with respect to IEC PAS

63077:2016:
a) the scope was delineated more clearly;

b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added;

c) smaller corrections were performed.
---------------------- Page: 9 ----------------------
SIST EN IEC 63077:2020
– 4 – IEC 63077:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
62B/1149/FDIS 62B/1155/RVD

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
– requirements and definitions: roman type;

– informative material appearing outside of tables, such as notes, examples and references: in smaller type.

Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3: SMALL CAPITALS.

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
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SIST EN IEC 63077:2020
IEC 63077:2019 © IEC 2019 – 5 –
INTRODUCTION

This document specifies requirements for a quality management system that can be used by

organizations involved in REFURBISHMENT of MEDICAL IMAGING EQUIPMENT.

The requirements defined in this document can be used by MANUFACTURERS or organizations

providing REFURBISHMENT. Organizations providing REFURBISHMENT can voluntarily choose to

conform to the requirements of this document or can be required by contract with the

MANUFACTURER of the MEDICAL IMAGING EQUIPMENT to conform.

Several jurisdictions have regulatory requirements regarding refurbished MEDICAL IMAGING

EQUIPMENT e.g. regarding the import and making refurbished MEDICAL IMAGING EQUIPMENT

available. These regulatory requirements differ from nation to nation and region to region. The

organizations involved in REFURBISHMENT of MEDICAL IMAGING EQUIPMENT should understand

how the regulatory requirements in the several jurisdictions will be interpreted and may be

met by applying this document.

In some jurisdictions a definition of the term remanufacturer is available. This document does

not cover the topic of how organizations are acting in the role of a remanufacturer.

This document can also be used by internal and external parties, including certification bodies,

to assess the organization’s ability to meet requirements applicable for the REFURBISHMENT of

MEDICAL IMAGING EQUIPMENT.

It is emphasized that the requirements specified in this document are complementary to other

International Standards such as on quality management system and on RISK management.

There is a wide variety of medical equipment with different requirements on REFURBISHMENT.

Therefore, this document only applies to named groups of MEDICAL IMAGING EQUIPMENT. These

groups are defined in Clause 1 Scope.
---------------------- Page: 11 ----------------------
SIST EN IEC 63077:2020
– 6 – IEC 63077:2019 © IEC 2019
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
1 Scope

This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING

EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of

safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL

IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR,

REWORK, software/hardware updates, and the replacement of worn parts with original parts.

This document enumerates the actions, that are performed, and the manner consistent, with

relevant specifications and service procedures required to ensure that the REFURBISHMENT of

MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING

EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or

applicable valid registration.
The MEDICAL IMAGING EQUIPMENT and systems covered by this document include:
– X-RAY EQUIPMENT;
– X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES;
– X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY;
– MAGNETIC RESONANCE EQUIPMENT;
– ULTRASONIC DIAGNOSTIC EQUIPMENT;
– GAMMA CAMERAS;
– PLANAR WHOLEBODY IMAGING EQUIPMENT;
– equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT);
– SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR
COMPUTED TOMOGRAPHY (CT);
– POSITRON EMISSION TOMOGRAPHS (PET);

– PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT

FOR COMPUTED TOMOGRAPHY (CT);
– PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC
RESONANCE EQUIPMENT; and
– other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above.

This document does not apply to endoscopic equipment, funduscopic equipment, radiation

therapy equipment, nor associated systems.
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 13485:2016, Medical devices – Quality management systems – Requirements for
regulatory purposes

ISO 14971:2007, Medical devices – Application of risk management to medical devices

---------------------- Page: 12 ----------------------
SIST EN IEC 63077:2020
IEC 63077:2019 © IEC 2019 – 7 –
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:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
EXPECTED SERVICE LIFE

time period specified by the MANUFACTURER during which the medical electrical equipment or

medical electrical system is expected to remain safe for use (i.e. maintain basic safety and

essential performance)
Note 1 to entry: Maintenance can be necessary during the EXPECTED SERVICE LIFE.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.28]
3.2
INTENDED USE
INTENDED PURPOSE

use for which a PRODUCT, PROCESS, or service is intended according to the specifications,

instructions and information provided by the MANUFACTURER

Note 1 to entry: INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as

intended by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not

only the medical purpose, but maintenance, transport, etc. as well.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.44]
3.3
MANUFACTURER

natural or legal person with responsibility for the design, manufacture, packaging, labelling,

assembling, or adapting MEDICAL IMAGING EQUIPMENT, regardless of whether these operations

are performed by that person or on that person's behalf by a third party

Note 1 to entry: Adapting includes making substantial modifications to MEDICAL IMAGING EQUIPMENT already in use.

[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.55, modified – The term MEDICAL IMAGING

EQUIPMENT is replacing ME EQUIPMENT or ME SYSTEM in the definition and in the Note to entry,

and three Notes to entry have been deleted.]
3.4
MEDICAL IMAGING EQUIPMENT
medical electrical equipment that provides images for clinical applications

Note 1 to entry: See IEC 60601-1:2005, 3.63 for a definition of MEDICAL ELECTRICAL EQUIPMENT.

3.5
NORMAL USE

operation, including routine inspection and adjustments by any OPERATOR, and stand-by,

according to the instructions for use
Not
...

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