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.

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.

General Information

Status
Published
Publication Date
12-Nov-2019
Current Stage
PPUB - Publication issued
Completion Date
13-Nov-2019
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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
IEC 63077:2019-11(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
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: 3 ----------------------
– 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

---------------------- Page: 4 ----------------------
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

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services carried out by independent certification bodies.

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

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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: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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: 7 ----------------------
– 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: 8 ----------------------
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

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]
---------------------- Page: 9 ----------------------
– 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]
---------------------- Page: 10 ----------------------
IEC 63077:2019 © IEC 2019 – 9 –
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

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.
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– 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 manag
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