SIST EN IEC 63077:2020

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.

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SIST EN IEC 63077:2020

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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

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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

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SIST EN IEC 63077:2020
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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.

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SIST EN IEC 63077:2020
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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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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.

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SIST EN IEC 63077:2020
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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

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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
...