I E C P AS 63 0 7 7

®
Edition 1 .0 201 6-1 1

P U B LI C LY AVAI LAB LE

S P E C I F I C ATI ON

P RE -S TAN D ARD

G ood refu rbi s h m e n t practi ces for m e d i cal i m ag i n g eq u i pm en t

IEC PAS 63077:201 6-1 1 (en)

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

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I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 I E C P AS 63 0 7 7
®
Edition 1 .0 201 6-1 1

P U B LI C LY AVAI LAB LE

S P E C I F I C ATI ON

P RE -S TAN D ARD

G ood refu rbi s h m en t practi ces for m ed i cal i m ag i n g eq u i pm en t

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION

ICS 1 1 .040.55 ISBN 978-2-8322-3761 -8

Warn i n g ! M ake s u re th a t you ob tai n ed th i s p u b l i cati on from an au th ori zed d i stri b u tor.

® Registered trademark of the International Electrotechnical Commission

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n
 –2– I EC PAS 63077:201 6 © I EC 201 6

CONTENTS

FOREWORD . .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... . .. .. ... ... ... ... ... ... ... ... .. 3
I NTRODUCTI ON .. ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. .. . ... ... ... ... ... ... ... ... ... 5
1 Scope .. ... ... ... ... ... ... ... ... ... .. ... ... ... ... .. . ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... . 6
2 Norm ative references . ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... . 6
3 Terms and definitions . ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... . 6
4 General requirem ents for refurbishm ent of used m edical devices ... ... ... ... .. ... ... ... ... ... ... ... . 8
4. 1 Quality managem ent system ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... . .. .. ... ... ... ... ... ... ... ... ... . 8
4. 2 Resource managem ent ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... . .. ... ... ... ... .. ... ... ... ... ... ... ... ... 8
4. 3 Corrective and preventive action .. ... ... ... ... ... ... ... .. ... ... ... ... ... ... . .. ... ... ... ... ... ... ... .. ... ... .. 9
4. 4 Custom er com plaints . .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... . .. ... ... ... ... ... ... ... ... ... ... ... ... ... .. 9
4. 5 Production and service provision . ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... .. 9
4. 6 Control of non-conform ing product . ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... .. 9
4. 7 Post-m arket surveillance process . ... ... ... ... ... ... ... .. ... ... ... ... ... ... . .. ... ... ... ... ... ... ... .. ... ... .. 9
4. 8 Document control .. ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... . .. ... . 9
4. 9 Purchasing . ... ... ... ... ... ... ... ... .. ... ... ... ... . .. ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... .. . ... ... ... ... ... ... 9
4. 1 0 Control of design and design changes . ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... . 1 0
4. 1 1 Risk management process ... ... ... ... ... ... ... ... ... ... ... ... .. ... .. . ... ... ... ... ... ... ... ... ... ... ... ... .. .. 1 0
5 Specific requirem ents for good refurbishment practice .. ... ... ... ... .. ... ... ... ... ... ... ... ... .. . ... ... .. 1 0
5. 1 General . ... ... ... ... ... ... ... ... ... ... ... .. ... ... . .. ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... .. . ... ... ... ... ... ... 1 0
5. 2 Selection of medical im aging equipment for refurbishm ent .. ... ... ... .. ... ... ... ... ... ... ... .. 1 0
5. 3 Evaluating m arket access requirem ents . ... ... ... ... ... ... ... ... ... .. ... ... .. . ... ... ... ... ... ... ... ... . 1 0
5. 4 Preparation for refurbishm ent, disassembly, packing, and shipment . ... ... ... ... ... .. ... . 1 0
5. 5 Planning .. ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. . .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... . .. ... ... . 1 1
5. 6 I nstallation of safety updates (hardware/software) . ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... 1 1
5. 7 Perform ance and safety test ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... . .. .. ... ... ... ... ... ... ... ... .. 1 1
5. 8 Packing, shipm ent, and installation of refurbished m edical im aging
equipment ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... . .. .. ... ... ... ... . 1 1
5. 9 Record of refurbishm ent .. ... ... ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. ... ... ... ... ... ... ... . 1 1
5. 1 0 Refurbishment label ... .. ... ... ... ... ... ... ... ... ... ... ... ... ... . .. .. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... 1 1
Bibliograph y .. .. ... ... ... ... ... ... ... ... ... ... ... . .. ... ... ... .. ... ... ... ... ... ... ... ... ... ... ... ... .. . ... ... .. ... ... ... ... ... ... ... ... 1 2

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 I EC PAS 63077:201 6 © I EC 201 6 –3–

INTERNATI ONAL ELECTROTECHNI CAL COMMISSI ON

____________

G O O D RE F U RB I S H M E N T P R AC T I C E S

F O R M E D I C AL I M AG I N G E Q U I P M E N T

FOREWORD
1 ) The I nternati on al Electrotechni cal Comm ission (I EC) is a worl d wid e organization for stan dardization com prisin g
all n ation al el ectrotechnical comm ittees (I EC National Comm ittees). The object of I EC is to prom ote
internati onal co-operation on all q uestions concerni ng stand ardi zati on in the el ectrical an d electronic fi elds. To
this en d and in additi on to other acti vities, I EC pu blish es I nternational Stan dards, Techn ical Specificati ons,
Technical Reports, Publicl y Avail abl e Specificati ons (PAS) an d Gu ides (h ereafter referred to as “I EC
Publication(s)”). Th ei r preparation is entrusted to tech nical comm ittees; any I EC N ational Comm ittee interested
in the subj ect dealt with m ay partici pate in this preparatory work. I nternational, governm ental an d n on -
governm ental organ izations l iaising with th e I EC also participate i n this preparation. I EC collaborates closel y
with the I ntern ational Organi zation for Stand ardization (I SO) in accordance with con ditions determ ined by
agreem ent between th e two organi zati ons.
2) The form al decisions or ag reem ents of I EC on tech nical m atters express, as n early as possible, an i nternati onal
consensus of opi nion on the rel evant subjects since each technical com m ittee has representati on from all
interested I EC N ational Com m ittees.
3) I EC Publications have the form of recom m endations for intern ational use an d are accepted by I EC National
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transparentl y to the m axim um extent possible i n their national an d regi on al publicati ons. Any d ivergence
between an y I EC Publication and the correspondi ng national or regi on al publicati on sh all be clearl y in dicated in
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5) I EC itself d oes n ot provi de an y attestation of conform ity. I n depend ent certificati on bodies provi de conform ity
assessm ent services and, in som e areas, access to I EC m arks of conform ity. I EC is not responsi ble for any
services carri ed out by ind ependent certification bodi es.
6) All users shou ld ensure that th ey have the l atest editi on of thi s publicati on.
7) No liability shall attach to I EC or its directors, em ployees, servants or ag ents inclu din g in divi dual experts an d
m em bers of its technical com m ittees and I EC Nati on al Com m ittees for any person al i njury, property d am age or
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expenses arisi ng out of the publ ication, use of, or relian ce upon, this I EC Publicati on or any other I EC
Publications.
8) Attention is drawn to th e N orm ative references cited in th is publ ication. Use of the referenced publ ications is
indispensable for the correct applicati on of this publication.
9) Attention is drawn to the possibility that som e of the elem ents of this I EC Publication m ay be the su bject of
patent rig hts. I EC shall not be held responsibl e for identifyi ng any or all such patent ri ghts.

A PAS is a technical specification not fulfilling the requirem ents for a standard, but m ade
available to the public.

I EC PAS 63077 has been processed by subcomm ittee 62B: Diagnostic im aging equipment, of
I EC technical committee 62: Electrical equipment in medical practice.
The text of this PAS is based on the This PAS was approved for
following docum ent: publ ication by th e P-m em bers of the
comm ittee concerned as ind icated in
the foll owi ng d ocum ent
D ra ft P AS R e p o rt o n vo ti n g

62B/1 022/PAS 62B/1 030/RVC

Following publication of this PAS, which is a pre-standard publication, the technical comm ittee
or subcom mittee concerned may transform it into an I nternational Standard.

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 –4– I EC PAS 63077:201 6 © I EC 201 6

This PAS shall remain valid for an initial m axim um period of 3 years starting from the
publication date. The validity m ay be extended for a single period up to a maxim um of
3 years, at the end of which it shall be published as another type of normative docum ent, or
shall be withdrawn.

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 I EC PAS 63077:201 6 © I EC 201 6 –5–

INTRODUCTION
Keeping up with the latest innovations in medical technology often involves replacing
equipm ent in m edical practice before it reaches the end of its expected service life. This is
because innovation cycles for medical technology are m uch shorter than the functional
lifecycle of capital equipm ent. As a result, a sustainable resource management model is
required: earl y replacement of installed medical im aging equipm ent by newer technolog y is
more econom icall y feasible if the residual value of the existing m edical imaging equipment is
utilized.

Conserving assets is a fundam ental principle of ecological thinking in a recycling econom y.

Several m edical imaging equipm ent companies have alread y set up quality m anagement
systems to refurbish used m edical im aging equipment and have delivered this refurbished
equipm ent across the healthcare sector for m any years. Refurbishm ent addresses the high
demand for affordable and reliable products. Customers of this used equipm ent are not only
sm all hospitals with limited budgets but also leading medical institutes. The EU and the US
represent by far the two largest m arkets for refurbished m edical equipm ent. Refurbishment of
used m edical im aging equipment is a well-established elem ent of the healthcare econom y.

I f used medical imaging equipment is not accuratel y m aintained according to requirem ents
defined by the manufacturer, it m ay result in additional risk for patients and operators.
Consequentl y, som e countries have imposed bans on the importation of used m edical im aging
equipm ent to protect public health. These bans fail to distinguish between quality-assured
refurbished medical imaging equipm ent and second-hand medical imaging equipm ent of
undefined quality, with the effect that patients m ay be denied access to the safe and
econom ical medical im aging equipment they need.

Safety and effectiveness are the m ost im portant aspects to consider with m edical im aging
equipm ent, including used equipment. To ensure safety and effectiveness, used medical
im aging equipment has to be refurbished in a highl y specialized and quality-assured way.

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 –6– I EC PAS 63077:201 6 © I EC 201 6

G O O D RE F U RB I S H M E N T P R AC T I C E S

F O R M E D I C AL I M AG I N G E Q U I P M E N T

1 S cop e

This document describes and defines the process of refurbishment of used m edical im aging
equipm ent and applies to the restoring of used medical im aging equipm ent to a condition of
safety and effectiveness com parable to that of new equipment. This restoration includes
actions such as repair, rework, software/hardware updates, and the replacement of worn parts
with original parts. This document enum erates the actions that m ust be perform ed and the
manner consistent with product specifications and service procedures required to ensure that
the refurbishm ent of medical imaging equipment is done without changing the finished
medical im aging equipment’s performance, safety specifications, or intended use according to
its original or applicable valid registration.

2 N o rm a t i ve re fe re n c e s

The following docum ents are referred to in the text in such a way that som e or all of their
content constitutes requirements of this docum ent. For dated references, onl y the edition
cited applies. For undated references, the latest edition of the referenced docum ent (including
an y am endm ents) applies.

I SO 1 3485: 201 6, Medical devices – Quality management systems – Requirements for

regulatory purposes
ISO 1 4971 : 2007, Medical devices – Application of risk management to medical devices
3 T e rm s a n d d e fi n i t i o n s

For the purposes of this docum ent, the following terms and definitions apply.

I SO and I EC maintain term inological databases for use in standardization at the following
addresses:
• I EC Electropedia: available at http://www. electropedia. org/
• I SO Online browsing platform : available at http: //www. iso. org/obp
3. 1

exp e cted s e rv i c e l i fe

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 perform ance)
Note 1 to entry: Maintenance can be n ecessary d uri ng th e expected service life.

[SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3. 28]

3. 2

i n te n d e d use

i n te n d e d p u rp o s e

use for which a product, process, or service is intended according to the specifications,
instructions and inform ation provided by the manufacturer

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 I EC PAS 63077:201 6 © I EC 201 6 –7–

Note 1 to entry: I ntend ed use shoul d n ot be confused with norm al use. While both inclu d e the concept of use as
inten ded by th e m anufactu rer, inten ded use focuses on the m edical pu rpose while norm al use incorporates not onl y
the m edical pu rpose, but m aintenance, transport, etc. as well.

[SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3. 44]

3. 3
man u factu rer
natural or legal person with responsibility for the design, m anufacture, packaging, labelling,
assembling, or adapting medical im aging equipm ent, regardless of whether these operations
are perform ed by that person or on that person's behalf by a third party
Note 1 to entry: I SO 1 3485: 201 6 defin es “labell ing ” as “written, printed or graphic m atter as:
a) affi xed to a m edical d evice or any of its contain ers or wrappers, or
b) accom panyin g a m edical d evice,
rel ated to i dentification, techni cal descripti on, and use of the m edical device, but exclu din g shippi ng d ocum ents. I n
this docum ent, that m aterial is described as m arkings and accom panyi ng d ocum ent.
Note 2 to entry: Ad apti ng incl udes m aking substanti al m odifi cations to m edical im aging equ ipm ent alread y in use.
Note 3 to entry: I n som e jurisdictions, the responsible refurbisher can be consi dered a m anufacturer when
involved i n the acti vities d escri bed.
Note 4 to entry: Ad apted from I SO 1 4971 : 2007, 2. 8.

[SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3. 55, modified – The definition and Note 2 have
been reworded. ]

3. 4
med i cal im ag in g eq u ipmen t
medical electrical equipment that provides images for clinical applications
Note 1 to entry: See I EC 60601 -1 : 2005/AMD1 : 201 2, 3. 63 for a defi nition of m edical el ectri cal equi pm ent.

3. 5
n ormal u se
operation, including routine inspection and adj ustments by an y operator, and stand-by,
according to the instructions for use

Note 1 to entry: N orm al use should not be confused with i ntend ed use. While both incl ud e the concept of use as
inten ded by th e m anufactu rer, inten ded use focuses on the m edical pu rpose while norm al use incorporates not onl y
the m edical pu rpose, but m aintenance, transport, etc. as well.

[SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3. 71 ]

3. 6
operator
person handling the medical imaging equipm ent

[SOU RCE: I EC 60601 -1 : 2005/AMD1 : 201 2, 3.73, modified – The definition has been
reworded. ]

3. 7
refu rbi sh er
natural or legal person who conducts refurbishm ent of m edical im aging equipm ent

3. 8
pati en t
living being (person or anim al) undergoing a m edical, surgical or dental procedure
Note 1 to entry: A patient can be an operator.

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 –8– I EC PAS 63077:201 6 © I EC 201 6

[SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 3. 76]

3. 9
process
set of inter-related or interacting activities which transform s inputs into outputs

[SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 3. 89]

3. 1 0
refu rbi sh m en t
process or combination of processes applied during the expected service life to restore used
medical im aging equipm ent to a condition of safety and effectiveness com parable to when
new

Note 1 to entry: Refu rbishm ent can inclu de activities such as repair, rework, repl acem ent of worn parts, and
update of software/hard ware but shall n ot includ e acti vities th at result i n regul atory su bm issions.

3. 1 1
repai r
means for restoring to a safe, functional, normal condition

[SOU RCE: I EC 62353: 201 4, 3.39]

3. 1 2
rework
action taken on a nonconform ing product so that it will fulfill the specified Device Master
Record requirem ents before it is released for distribution

[SOU RCE: 21 CFR 820, 3 (x)]

3. 1 3
ri sk
combination of the probability of occurrence of harm and the severity of that harm

[SOU RCE: I EC 60601 -1 : 2005/AMD1 :201 2, 3. 1 02]

3. 1 4
u sed m ed i cal im ag in g equ ipm en t
medical imaging equipm ent that has been put into service

4 General req ui rem ents for refurbi shm ent of used m edi cal devi ces

4. 1 Qu al ity m an ag em en t system

Refurbishm ent of used m edical imaging equipment shall be conducted under a quality
managem ent system (QMS) of the refurbisher in compliance with I SO 1 3485: 201 6. I n addition
to I SO 1 3485:201 6, the provisions in paragraphs 4.2 to 4. 1 1 shall be applied.

4. 2 Resou rce m an ag em en t

The refurbisher shall determ ine, and provide adequate resources, including trained and
qualified personal, m aintained and calibrated equipment, and instructions, procedures, files,
records, or docum ents to perform the refurbishment, as well as an environment for
refurbishm ent that is in com plete compliance with the applicable environmental, occupational
health and safety, and pest control requirem ents.

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 I EC PAS 63077:201 6 © I EC 201 6 –9–

4.3 Corrective and preventive action

The refurbisher shall implement a com prehensive corrective action and preventive action
(CAPA) process, addressing the specific aspects of the refurbishm ent of used medical
im aging equipment.

In addition, in the event that the refurbisher identifies, through its CAPA system , safety-
related issues that are the responsibility of the original manufacturer and not related to the
refurbishm ent, it shall inform the original m anufacturer accordingl y.

4.4 Customer complaints

The refurbisher shall have in place a system for m anaging com plaints.

In addition, the refurbisher shall communicate to the original manufacturer all custom er
complaints that are not related to the refurbishment of the equipm ent.

4.5 Production and service provision

The refurbisher shall have documented procedures for refurbishm ent and service including
but not lim ited to process validation, disinfection processes, identification, traceability and
packaging. I n addition the organization shall m ake provisions to have the knowledge and the
ability for installing and servicing medical imaging equipm ent, or to ensure that servicing can
be m ade available in those m arkets where the refurbisher m akes refurbished medical im aging
equipment available on the m arket.

4.6 Control of non-conforming product

The refurbisher shall ensure that a product that does not conform to product requirements is
identified during refurbishm ent and controlled to prevent its unintended use or delivery. When
a non-conform ing product is corrected during refurbishm ent, it shall be subj ect to re-
verification to dem onstrate conformity to the requirem ents of the original m anufacturer.

4.7 Post-market surveillance process

The refurbisher shall collect feedback from custom ers and establish docum ented procedures
to notify regulatory authorities of adverse events. The process shall also determine if the
adverse event is related to the refurbishm ent of the used medical im aging equipment or needs
to be reported to the original m anufacturer.

The refurbisher shall also establish his or her own post-m arket surveillance process to
monitor whether the additional risks resulting from refurbishment have been adequatel y
mitigated.

The refurbisher shall enable monitoring of its installed base of refurbished m edical imaging
equipment to allow for update managem ent for safety and effectiveness.

4.8 Document control

The refurbisher shall control all work instructions and procedures used to refurbish medical
im aging equipment.

4.9 Purchasing
The refurbisher shall establish dedicated supplier m anagement capabilities when com ponents
or services are purchased.

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 – 10 – I EC PAS 63077:201 6 © I EC 201 6

4.1 0 Control of design and design changes

The refurbisher shall review, verify, and validate potential design changes to ensure that the
safety and effectiveness requirements of the equipment are not changed from its original or
applicable valid registration. All changes, including parts, shall be evaluated to determine if
the refurbisher needs registration, as he or she m ay becom e the legal m anufacturer.

4.1 1 Risk management process

The refurbisher shall also establish a risk m anagem ent process that includes an y risk
introduced by the refurbishment of used medical imaging equipm ent. 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 refurbishm ent of used medical
imaging equipm ent that, in addition to the general requirem ents described in Clause 4
includes the following specific requirem ents.

5.2 Selection of medical imaging equipment for refurbishment

The refurbisher shall determ ine the criteria that used medical im aging equipment need to
meet in order to qualify for refurbishment, based on an assessment of the risk (in accordance
with I SO 1 4971 : 2007) associated with refurbishment, for an y type of m edical im aging
equipm ent it wishes to process.

This determination shall consider the following items:

a) intended use and norm al use of the equipm ent;
b) expected service life;
c) applicable standards;
d) service/m aintenance history for the equipment;
e) existing procedures for the refurbishment of m edical im aging equipment, such as service,
repair, production, and maintenance.
Used m edical im aging equipm ent 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 m andatory safety
updates, shall not be refurbished.

5.3 Evaluating market access requirements

To ensure regulatory compliance, the refurbisher shall have a process in place to evaluate
market access requirements, such as valid registrations and licenses or restrictions, and to
provide instructions for use in the appropriate languages, safety inform ation, warnings, and
labels.

Refurbished medical imaging equipm ent for which the registrations or licenses of the original
or refurbished m edical im aging equipment have been discontinued or where there is no
original license may require the refurbisher to obtain a valid registration prior to
comm ercialization.

5.4 Preparation for refurbishment, disassembly, packing, and shipment

The refurbisher shall have procedures in place to ensure that the m edical imaging equipm ent
has been suitabl y cleaned and disinfected to avoid harm ing an y person involved in the
disassembly, packing, and shipm ent. The m edical imaging equipm ent shall be adequatel y
I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n
 I EC PAS 63077:201 6 © I EC 201 6 – 11 –

disassem bled (if necessary) and packed to prevent damage during shipment. Appropriate
procedures shall be in place to avoid violation of privacy rules concerning patient data
possibl y stored on the relevant equipm ent.

5. 5 Pl an n i n g

A refurbishm ent plan shall be developed and followed to restore the medical im aging
equipm ent to a condition of safety and effectiveness com parable to when new.

5. 6 I n s ta l l a ti o n o f s a fe t y u p d a t e s ( h a rd w a re /s o ft w a re )

The refurbisher shall install all safety updates released by the m anufacturer for the relevant
medical im aging equipment since it was placed on the m arket.

5. 7 P e rfo rm a n c e a n d s a fe t y t e s t

Tests specified for the original medical imaging equipm ent shall be conducted to verify that
original perform ance and safety specifications are m et, including all m andatory safety
updates.

5. 8 P a c ki n g , s h i p m e n t, an d i n stal l ati on o f re fu rb i s h e d m ed i cal i magin g eq u i pm en t

Packing and shipm ent shall be adequate to prevent damage during transit and load/unload
operations. I nstallation, inspection, and an y required testing shall be perform ed according to
docum ented procedures of the manufacturer.

5. 9 Re c o rd o f re fu rb i s h m e n t

The record shall reflect for the relevant m edical imaging equipment that all operations and
processes described in the refurbishment plan have been accom plished. I n addition, the
record of refurbishment is specificall y required to contain, or refer to the location of, the
following inform ation:
a) date of refurbishment;
b) an y m edical imaging equipm ent identification and control num bers used;
c) the prim ary identification label and labelling used for each refurbished unit;
d) the acceptance records that dem onstrate that the equipment has been refurbished in
accordance with the refurbishment plan;
e) list of replaced parts and their identification informati on.
The record shall authenticate an y refurbished m edical im aging equipm ent through m eans that
allow inspection by authorities and verification by custom ers as requested.

5. 1 0 R e fu rb i s h m e n t l a b e l

The refurbisher shall label all refurbished medical imaging equipment in proxim ity to the
original label identifying that the medical imaging equipment has been refurbished by the
refurbisher and the date of refurbishment.

I n tern ati o n al E l ectro tech n i cal C o m m i s s i o n

 – 12 – I EC PAS 63077:201 6 © I EC 201 6

Bibliography
I EC 60601 -1 : 2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
I EC 60601 -1 : 2005/AMD1 :201 2

Medical electrical equipment – Recurrent test and test after repair of medical
I EC 62353: 201 4,
electrical equipment
US FDA 21 CFR Part 820 Quality System Regulation, Title 21 – Food and drugs – Chapter I –
Food and drug administration department of health and human services – Subchapter H –
Medical devices – Part 820: Quality system regulation

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