IEC 63077:2019

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

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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

– 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

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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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.

– 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.
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.

– 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

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
Note 1 to entry: NORMAL USE should not be confused with INTENDED 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, 3.71]

– 8 – IEC 63077:2019 © IEC 2019
3.6
OPERATOR
person handling the MEDICAL IMAGING EQUIPMENT
[SOURCE: IEC 60601-1:2005, 3.73, modified – "Equipment" was replaced by "medical
imaging equipment".]
3.7
REFURBISHER
natural or legal person who conducts REFURBISHMENT of MEDICAL IMAGING EQUIPMENT
Note 1 to entry: In some jurisdictions, the responsible REFURBISHER can be considered as MANUFACTURER when
involved in the activities described.
3.8
PATIENT
living being (person or animal) undergoing a medical, surgical or dental procedure
Note 1 to entry: A PATIENT can be an OPERATOR.
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.76]
3.9
PROCESS
set of inter-related or interacting activities which transforms inputs into outputs
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.89]
3.10
PRODUCT
result of PROCESS
[SOURCE: ISO 13485:2016, 3.15]
3.11
REFURBISHMENT
PROCESS or combination of PROCESSES applied during the EXPECTED SERVICE LIFE to restore
USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance according to the
specification of the MANUFACTURER.
Note 1 to entry: REFURBISHMENT can include activities such as REPAIR, REWORK, replacement of worn parts, and
update of software/hardware but does not include activities that result in the need of a new certification of the
MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the REFURBISHER.
Note 2 to entry: REFURBISHMENT does not include restoration after the EXPECTED SERVICE LIFE.
Note 3 to entry: In some jurisdictions a definition of the term remanufacturer is available. REFURBISHMENT differs
from actions related to REFURBISHER acting in the role of a remanufacturer.
Note 4 to entry: In some jurisdictions a definition of the term reprocessing is available. In those jurisdictions the
term reprocessing is typically related to reusable medical devices such as single-use medical devices and is
related to processes such as sterilization. REFURBISHMENT is different from reprocessing.
Note 5 to entry: REFURBISHMENT may result in a higher level of safety because e.g. safety updates released by
the MANUFACTURER for the relevant MEDICAL IMAGING EQUIPMENT are applied within REFURBISHMENT.
3.12
REPAIR
means for restoring to a safe, functional, normal condition
[SOURCE: IEC 62353:2014, 3.39]

3.13
REWORK
action taken on a nonconforming PRODUCT so that it will fulfill the specified Device Master
Record requirements before it is released for distribution
3.14
RISK
combination of the probability of occurrence of harm and the severity of that harm
[SOURCE: IEC 60601-1:2005/AMD1:2012, 3.102]
3.15
USED MEDICAL IMAGING EQUIPMENT
MEDICAL IMAGING EQUIPMENT that has been put into service
4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT
4.1 Quality management system
EFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT shall be conducted under a quality
R
management system (QMS) of the REFURBISHER in compliance with ISO 13485:2016. In
addition to ISO 13485:2016, the provisions in 4.2 to 4.11 shall be applied.
4.2 Resource management
The REFURBISHER shall determine, and provide adequate resources, including:
– trained and qualified personal;
– maintained and calibrated equipment;
– instructions, procedures, files, records, or documents to perform the REFURBISHMENT; and
– an environment for REFURBISHMENT that is in compliance with the applicable environmental,
occupational health and safety requirements.
4.3 Corrective and preventive action
The REFURBISHER shall implement a comprehensive corrective action and preventive action
(CAPA) PROCESS, addressing the specific aspects of the REFURBISHMENT of USED MEDICAL
IMAGING EQUIPMENT.
REFURBISHER identifies, through its CAPA system, safety
In addition, in the event that the
related issues that are the responsibility of the original MANUFACTURER and not related to the
REFURBISHMENT, it shall inform the original MANUFACTURER accordingly.
4.4 Customer complaints
The REFURBISHER shall have in place a system for managing complaints.
In addition, the REFURBISHER shall communicate to the original MANUFACTURER all customer
complaints that are not related to the REFURBISHMENT of the MEDICAL IMAGING EQUIPMENT.
4.5 Production and service provision
The REFURBISHER shall have documented procedures for REFURBISHMENT and service including
but not limited to PROCESS validation, disinfection PROCESSES, identification, traceability and
packaging. In addition, the REFURBISHER shall make provisions to have the knowledge and the
ability for installing and servicing MEDICAL IMAGING EQUIPMENT, or to ensure that servicing can
be made available in those markets where the REFURBISHER makes refurbished MEDICAL
IMAGING EQUIPMENT available on the market.

– 10 – IEC 63077:2019 © IEC 2019
4.6 Control of nonconforming PRODUCT
The REFURBISHER shall ensure that a PRODUCT, that does not conform to PRODUCT
requirements, is identified during REFURBISHMENT and controlled to prevent its unintended use
or delivery. When a nonconforming PRODUCT is corrected during REFURBISHMENT, it shall be
subject to re-verification to demonstrate conformity to the requirements of the original
MANUFACTURER.
4.7 Post-market surveillance PROCESS
The REFURBISHER shall collect feedback from customers and establish documented
procedures to notify regulatory authorities of adverse events caused by the refurbished
MEDICAL IMAGING EQUIPMENT. The PROCESS shall also determine if the adverse event is related
to the REFURBISHMENT of the USED MEDICAL IMAGING EQUIPMENT or needs to be reported to the
original MANUFACTURER.
The REFURBISHER shall also establish its own post-market surveillance PROCESS to monitor
whether the additional RISKS resulting from REFURBISHMENT have been adequately mitigated.
The REFURBISHER shall enable monitoring of its installed base of refurbished MEDICAL IMAGING
to allow for update management for safety and performance.
EQUIPMENT
NOTE To term installed base: All refurbished MEDICAL IMAGING EQUIPMENT provided by the REFURBISHER and
installed, which meets all acceptance criteria for verification of installation.
4.8 Document control
The REFURBISHER shall control all work instructions and procedures used to refurbish MEDICAL
IMAGING EQUIPMENT.
4.9 Purchasing
The REFURBISHER shall document procedures to ensure that purchased components, service
parts and other materials such as packaging material, services as needed for REFURBISHMENT
conforms to purchasing information as specified by the MANUFACTURER of the MEDICAL IMAGING
EQUIPMENT. The REFURBISHER shall establish dedicated supplier management capabilities
when components, services, or other materials such as packaging materials, services are
purchased.
4.10 Control of design and design changes
The REFURBISHER shall review, verify, and validate potential design changes to ensure that the
safety and performance requirements of the MEDICAL IMAGING EQUIPMENT are not changed from
its original or applicable valid registration. All changes, including parts, shall be evaluated to
determine if the MEDICAL IMAGING EQUIPMENT needs new certification and the REFURBISHER
needs registration, as it may become the legal MANUFACTURER.
NOTE Control of design and design changes are not applicable to a REFURBISHER because this can result in the
need of a new certification of the MEDICAL IMAGING EQUIPMENT and a legal MANUFACTURER status of the
REFURBISHER.
4.11 RISK management PROCESS
The REFURBISHER shall also establish a RISK management PROCESS that includes any RISK
introduced by the REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT. This includes changes
that would affect parts.
5 Specific requirements for good REFURBISHMENT practice
5.1 General
The REFURBISHER shall establish a specific PROCESS for the REFURBISHMENT of USED MEDICAL
IMAGING EQUIPMENT that, in addition to the general requirements described in Clause 4,
includes the following specific requirements.
5.2 Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT
The REFURBISHER shall determine the criteria that USED MEDICAL IMAGING EQUIPMENT needs to
meet in order to qualify for REFURBISHMENT, based on an assessment of the RISK in
accordance with ISO 14971:2007 associated with REFURBISHMENT, for any type of MEDICAL
IMAGING EQUIPMENT it wishes to PROCESS.
This determination shall consider the following items:
a) INTENDED USE and NORMAL USE of the MEDICAL IMAGING EQUIPMENT;
b) EXPECTED SERVICE LIFE;
c) applicable standards;
d) service/maintenance history for the MEDICAL IMAGING EQUIPMENT;
e) existing procedures for the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT, such as service,
REPAIR, production, and maintenance.
USED MEDICAL IMAGING EQUIPMENT that is at the end of EXPECTED SERVICE LIFE or that cannot be
restored to at least the original safety and performance levels, including all mandatory safety
updates, shall not be refurbished.
5.3 Evaluating market access requirements
REFURBISHER shall have a PROCESS in place to evaluate
To ensure regulatory compliance, the
market access requirements, such as valid registrations and licenses or restrictions, and to
provide instructions for use in the appropriate languages, safety information, warnings, and
labels.
Only a MANUFACTURER can register a MEDICAL IMAGING EQUIPMENT.
Refurbished MEDICAL IMAGING EQUIPMENT for which the registrations or licenses of the original
or refurbished MEDICAL IMAGING EQUIPMENT has been discontinued or where there is no license
may require a registration or license prior to commercialization of the refurbished MEDICAL
IMAGING EQUIPMENT.
5.4 Preparation for REFURBISHMENT, disassembly, packing, and transport
The REFURBISHER shall have procedures in place to ensure that the MEDICAL IMAGING
EQUIPMENT has been suitably cleaned and disinfected to avoid harming any person involved in
the disassembly, packing, and transport. The MEDICAL IMAGING EQUIPMENT shall be adequately
disassembled (if necessary) and packed to prevent damage during transport. Appropriate
procedures shall be in place to avoid violation of privacy rules concerning PATIENT data
possibly stored on the relevant MEDICAL IMAGING EQUIPMENT.
5.5 Planning
A REFURBISHMENT plan shall be developed and followed to restore the MEDICAL IMAGING
EQUIPMENT to a condition of safety and performance according to the specifications of the
MANUFACTURER.
– 12 – IEC 63077:2019 © IEC 2019
5.6 Installation of software and hardware to ensure the safety of the MEDICAL IMAGING
EQUIPMENT
The REFURBISHER shall install all software and hardware safety updates released by the
MANUFACTURER for the relevant MEDICAL IMAGING EQUIPMENT since it was placed on the market
to ensure the safety of the MEDICAL IMAGING EQUIPMENT.
5.7 Performance and safety test
Tests specified for the original MEDICAL IMAGING EQUIPMENT shall be conducted to verify that
original performance and safety specifications are met, including all mandatory safety updates.
5.8 Packing, transport, and installation of refurbished MEDICAL IMAGING EQUIPMENT
Packing and transport shall be adequate to prevent damage during transit and load/unload
operations. Installation, inspection, and any required testing shall be performed according to
MANUFACTURER.
documented procedures of the
5.9 Record of REFURBISHMENT
The record shall reflect for the relevant MEDICAL IMAGING EQUIPMENT that all operations and
PROCESSES described in the REFURBISHMENT plan have been accomplished. In addition, the
record of REFURBISHMENT is specifically required to contain, or refer to the location of, the
following information:
a) date of REFURBISHMENT;
b) any MEDICAL IMAGING EQUIPMENT identification and control numbers used;
c) the primary identification label and labelling used for each refurbished MEDICAL IMAGING
EQUIPMENT;
MEDICAL IMAGING EQUIPMENT has been
d) the acceptance records that demonstrate that the
refurbished in accordance with the REFURBISHMENT plan;
e) list of replaced parts and their identification information;
f) REPAIR, REWORK and hardware/software updates.
The record shall authenticate any refurbished MEDICAL IMAGING EQUIPMENT through means that
allow inspection by authorities and verification by customers as requested.
5.10 REFURBISHMENT label
The REFURBISHER shall label all refurbished MEDICAL IMAGING EQUIPMENT, identifying that the
MEDICAL IMAGING EQUIPMENT has been refurbished by the REFURBISHER. The REFURBISHER label
shall include the year of REFURBISHMENT and be placed in proximity to the original label
without obscuring any original label.

Annex A
(informative)
Cross reference list of the contents of IEC 63077 versus ISO 13485
Table A.1 displays a cross reference list of the contents of IEC 63077 versus ISO 13485:2016.
Table A.1 – Cross reference list of the contents of IEC 63077 versus ISO 13485
IEC 63077 ISO 13485:2016 Remarks
Subclause Subclause title/Requirement Subclause Subclause title/Requirement

4.2 Resource management
trained and qualified personal 6.2 Human resources Adapted

maintained and calibrated equipment 7.6 Control of monitoring and Adapted
measuring equipment
instructions, procedures, files,
7.1 Planning of PRODUCT realization Addition
records, or documents to perform
the REFURBISHMENT
environment for REFURBISHMENT 6.4.1 Work environment Addition
6.4.2 Contamination control
4.3 Corrective and preventive action

a comprehensive corrective action 8.5.2 Corrective action Addition
and preventive action (CAPA) 8.5.3 Preventive action
PROCESS for specific aspect of
REFURBISHMENT
to communicate with original 8.5 Improvement Addition
MANUFACTURER when safety related
issue that original MANUFACTURER is
responsible
4.4 Customer complaints
a system for managing complaints 8.2.2 Complaint handling Adapted

to communicate to the original 8.2 Monitoring and measurement Addition
MANUFACTURER all complaints that
are not related the REFURBISHMENT

4.5 Production and service provision

documented procedures for 7.5.1 Control of production and Addition
REFURBISHMENT and service service provision

PROCESS validation of 7.5.6 Validation of processes for Addition
REFURBISHMENT production and service provision

identification for refurbished MEDICAL 7.5.8 Identification Addition
IMAGING EQUIPMENT
traceability 7.5.9 Traceability Addition

disinfection 7.5.2 a) Cleanliness of PRODUCT Addition

knowledge and ability for installing 6.2 Human resource Addition
and servicing
7.5.3 Installation activities
4.6 Control of nonconforming
PRODUCT
to ensure identification of non 8.3.1 General Addition
conforming refurbished MEDICAL
IMAGING EQUIPMENT and to prevent
unintended use and delivery
requirements when a nonconforming 8.3.4 Control of nonconforming Addition
refurbished MEDICAL IMAGING PRODUCT
EQUIPMENT is identified
– 14 – IEC 63077:2019 © IEC 2019
IEC 63077 ISO 13485:2016 Remarks
Subclause Subclause title/Requirement Subclause Subclause title/Requirement
4.7 Post-market surveillance PROCESS

collection of feedback from 8.5 Improvement Addition
customers
establishment of post market 8.5 Improvement Addition
surveillance PROCESS
monitoring of its installed base of 8.5 Improvement Addition
refurbished MEDICAL IMAGING
EQUIPMENT
4.8 Document control
control of all work instructions and 4.2.4 Control of documents Addition
procedures used for REFURBISHMENT

4.9 Purchasing
supplier management capabilities 7.4.1 Purchasing Addition
relevant for REFURBISHMENT
4.10 Control of design and design
changes
control of design changes by the 7.3.9 Control of design and design Addition
REFURBISHER changes
4.11 RISK management PROCESS
establishment of RISK management 7.1 Planning of PRODUCT realization Addition
for REFURBISHMENT
Bibliography
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
IEC 60601-2-33:2010, Medical electrical equipment – Part 2-33: Particular requirements for
the basic safety and essential performance of magnetic resonance equipment for medical
diagnosis
IEC 60601-2-37:2007, Medical electrical equipment – Part 2-37: Particular requirements for
the basic safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
IEC 60601-2-43:2010, Medical electrical equipment – Part 2-43: Particular requirements for
the basic safety and essential performance of X-ray equipment for interventional procedures
IEC TR 60788:2004, Medical electrical equipment – Glossary of defined terms
IEC 61223-2-6:2006, Evaluation and routine testing in medical imaging departments –
Part 2-6: Constancy tests – Imaging performance of computed tomography X-ray equipment
IEC 61675-2:2015, Radionuclide imaging devices – Characteristics and test conditions –
Part 2: Gamma cameras for planar, wholebody, and SPECT imaging
IEC TR 61948-3:2018, Nuclear medicine instrumentation – Routine tests – Part 3: Positron
emission tomographs
IEC 62353:2014, Medical electrical equipment – Recurrent test and test after repair of medical
electrical equipment
– 16 – IEC 63077:2019 © IEC 2019
Index of defined terms used in this document
NOTE In the present document, terms defined either in IEC 60601-1:2005, its collateral standards, in IEC
TR 60788:2004, in other IEC TC 62 publications or in Clause 3 of this standard were used.
EXPECTED SERVICE LIFE . 3.1
GAMMA CAMERA .IEC 60788:2004, rm-34-03
INTENDED USE . 3.2
MAGNETIC RESONANCE EQUIPMENT . IEC 60601-2-33:2010, 201.3.218
MANUFACTURER . 3.3
MEDICAL IMAGING EQUIPMENT . 3.4
NORMAL USE . IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.71
OPERATOR . 3.6
PLANAR WHOLEBODY IMAGING EQUIPMENT . IEC 61675-2:2015, 3.34
POSITRON EMISSION TOMOGRAPH . IEC TR 61948-3:2018, 3.9
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE . IEC 60601-2-43:2010, 201.3.203
REFURBISHER . 3.7
PATIENT . 3.8
PROCESS . 3.9
PRODUCT . 3.10
REFURBISHMENT . 3.11
REPAIR . 3.12
REWORK . 3.13
RISK . 3.14
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) . IEC 61675-2:2015, 3.44
USED MEDICAL IMAGING EQUIPMENT. 3.15
ULTRASONIC DIAGNOSTIC EQUIPMENT . IEC 60601-2-37:2007, 201.3.217
RISK MANAGEMENT . IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.107
RISK MANAGEMENT FILE . IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.108
X-RAY EQUIPMENT . IEC 60601-1-3:2008, 3.78
X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY .IEC 61223-2-6:2006, 3.2

____________
– 18 – IEC 63077:2019 © IEC 2019
SOMMAIRE
AVANT-PROPOS . 19
INTRODUCTION . 21
1 Domaine d’application . 22
2 Références normatives . 22
3 Termes et définitions . 23
4 Exigences générales relatives au RECONDITIONNEMENT des APPAREILS D’IMAGERIE
MEDICALE USAGES . 25
4.1 Système de management de la qualité . 25
...