Iec pas 63077 2016

IEC PAS 63077 Edition 1 0 201 6 1 1 PUBLICLY AVAILABLE SPECIFICATION PRE STANDARD Good refurbishment practices for medical imaging equipment IE C P A S 6 3 0 7 7 2 0 1 6 1 1 (e n ) ® International Ele[.]

IEC PA S 63077

Editio 1.0 2 16-1

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IEC PA S 63077

Edit io 1.0 2 16-1

INT ER NAT IONAL

ELECT R OT ECHNICAL

®

W arnin ! Mak e s re t hat y ou o t ain d t his publ c tion from a a thorize distribut or

FOREWORD 3

INTRODUCTION 5

1 Sco e 6

2 Normative ref eren es 6

3 Terms an def i ition 6

4 General req irements f or ref urbis ment of u ed medical devices 8

4.1 Qual ty management s stem 8

4.2 Resource management 8

4.3 Cor ective an preventive action 9

4.4 Cu tomer complaints 9

4 5 Prod ction an service provision

9 4.6 Control of non-conf ormin prod ct 9

4.7 Post-market s rvei an e proces 9

4.8 Doc ment control 9

4.9 Purc asin 9

4.10 Control of desig an desig c an es 10 4.1 Ris management proces 10 5 Sp cif i req irements f or go d refurbis ment practice 10 5.1 General 10 5.2 Selection of medical imagin eq ipment for refurbis ment 10 5.3 Evaluatin market ac es req irements 10 5.4 Pre aration f or ref urbis ment, disas embly, p c in , an s ipment 10 5.5 Plan in 1

5.6 In tal ation of saf ety updates (hardware/sof tware) 1

5.7 Per orman e an safety test 1

5.8 Pac in , s ipment, an in tal ation of ref urbis ed medical imagin equipment 1

5.9 Record of ref urbis ment 1

5.10 Ref urbis ment la el 1

Biblogra h 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

_

FOR MEDICAL IMAGING EQUIPMENT

1 Th Intern tio al Ele trote h ic l Commis io (IEC) is a worldwid org niz tio for sta d rdiz tio c mprisin

al n tio al ele trote h ic l c mmite s (IEC Natio al Commite s) Th o je t of IEC is to promote

intern tio al c -o eratio o al q e tio s c n ernin sta d rdiz tio in th ele tric l a d ele tro ic f i ld To

this e d a d in a ditio to oth r a tivitie , IEC p bls e Intern tio al Sta d rd , Te h ic l Sp cific tio s,

Te h ic l Re orts, Pu lcly Av ia le Sp cif i atio s (P S) a d Guid s (h re f ter refer e to a “IEC

Pu lc tio (s)”) Th ir pre aratio is e tru te to te h ic l c mmite s; a y IEC Natio al Commite intere te

in th s bje t d alt with ma p rticip te in this pre aratory work Intern tio al g v rnme tal a d n n

-g v rnme tal org niz tio s laisin with th IEC als p rticip te in this pre aratio IEC c la orate clo ely

with th Intern tio al Org niz tio f or Sta d rdiz tio (ISO) in a c rd n e with c n itio s d termin d b

a re me t b twe n th two org niz tio s

2) Th f ormal d cisio s or a re me ts of IEC o te h ic l maters e pre s, a n arly a p s ible, a intern tio al

c n e s s of o inio o th rele a t s bje ts sin e e c te h ic l c mmite h s re re e tatio fom al

intere te IEC Natio al Commite s

3) IEC Pu lc tio s h v th form of re omme d tio s f or intern tio al u e a d are a c pte b IEC Natio al

Commite s in th t s n e Whie al re s n ble ef forts are ma e to e s re th t th te h ic l c nte t of IEC

Pu lc tio s is a c rate, IEC c n ot b h ld re p n ible for th wa in whic th y are u e or f or a y

misinterpretatio b a y e d u er

4) In ord r to promote intern tio al u if ormity, IEC Natio al Commite s u d rta e to a ply IEC Pu lc tio s

tra s are tly to th ma imum e te t p s ible in th ir n tio al a d re io al p blc tio s An div rg n e

b twe n a y IEC Pu lc tio a d th c re p n in n tio al or re io al p blc tio s al b cle rly in ic te in

th later

5) IEC its lf d e n t pro id a y ate tatio of c nf ormity In e e d nt c rtific tio b die pro id c nf ormity

a s s me t s rvic s a d, in s me are s, a c s to IEC mark of c nf ormity IEC is n t re p n ible f or a y

s rvic s c rie o t b in e e d nt c rtif i atio b die

6) Al u ers s o lde s re th t th y h v th late t e itio of this p blc tio

7) No la i ty s al ata h to IEC or its dire tors, emplo e s, s rv nts or a e ts in lu in in ivid al e p rts a d

memb rs of its te h ic l c mmite s a d IEC Natio al Commite s f or a y p rs n l injury, pro erty d ma e or

oth r d ma e of a y n ture wh ts e er, wh th r dire t or in ire t, or for c sts (in lu in le al f ee ) a d

e p n e arisin o t of th p blc tio , u e of, or rela c u o , this IEC Pu lc tio or a y oth r IEC

Pu lc tio s

8) Ate tio is drawn to th Normativ refere c s cite in this p blc tio Us of th refere c d p blc tio s is

in is e s ble for th c r e t a plc tio of this p blc tio

9) Ate tio is drawn to th p s ibi ty th t s me of th eleme ts of this IEC Pu lc tio ma b th s bje t of

p te t rig ts IEC s al n t b h ld re p n ible for id ntif yin a y or al s c p te t rig ts

A PAS is a tec nical specification not fulfi in the req irements for a stan ard, but made

avai a le to the publ c

IEC PAS 6 0 7 has b en proces ed by s bcommite 6 B: Diag ostic imagin eq ipment, of

IEC tec nical commit e 6 : Electrical eq ipment in medical practice

Th te t of this P S is b s d o th

f olowin d c me t:

This P S wa a pro e for

p blc tio b th P-memb rs of th

c mmite c n ern d a in ic te in

th folowin d c me t

Fol owin publcation of this PAS, whic is a pre-stan ard publ cation, the tec nical commite

or s bcommite con erned may tran form it into an International Stan ard

This PAS s al remain val d for an initial maximum p riod of 3 ye rs startin f rom the

publ cation date The val dity may b exten ed for a sin le p riod up to a maximum of

3 ye rs, at the en of whic it s al b publs ed as another typ of normative doc ment, or

s al b with rawn

Ke pin up with the latest in ovation in medical tec nolog often in olves re lacin

eq ipment in medical practice b fore it re c es the en of its exp cted service lfe This is

b cau e in ovation c cles for medical tec nolog are mu h s orter than the fu ctional

l f ec cle of ca ital eq ipment As a res lt, a s staina le resource management model is

req ired: e rly re lacement of in tal ed medical imagin eq ipment by newer tec nolog is

more economical y f easible if the resid al value of the existin medical imagin eq ipment is

uti zed

Con ervin as ets is a f un amental prin iple of ecological thin in in a rec cl n economy

Several medical imagin eq ipment comp nies have alre dy set up q al ty management

s stems to refurbis u ed medical imagin eq ipment an have del vered this refurbis ed

eq ipment acros the he lth are sector for man ye rs Refurbis ment ad res es the hig

deman for aff orda le an rel a le prod cts Cu tomers of this u ed eq ipment are not only

smal hospitals with l mited bu gets but also le din medical in titutes The EU an the US

re resent by far the two largest markets f or ref urbis ed medical eq ipment Ref urbis ment of

u ed medical imagin eq ipment is a wel -esta l s ed element of the he lth are economy

If u ed medical imagin eq ipment is not ac urately maintained ac ordin to req irements

defined by the man facturer, it may res lt in ad itional ris for p tients an o erators

Con eq ently, some cou tries have imp sed b n on the imp rtation of u ed medical imagin

eq ipment to protect publ c he lth These b n f ai to distin uis b twe n q al ty-as ured

ref urbis ed medical imagin eq ipment an secon -han medical imagin eq ipment of

u def i ed q al ty, with the eff ect that p tients may b denied ac es to the safe an

economical medical imagin eq ipment they ne d

Saf ety an ef fectivenes are the most imp rtant asp cts to con ider with medical imagin

eq ipment, in lu in u ed eq ipment To en ure safety an eff ectivenes , u ed medical

imagin eq ipment has to b ref urbis ed in a hig ly sp cial zed and q al ty-as ured way

GOOD REFURBISHMENT PRA CTICES

FOR MEDICA L IMAGING EQUIPMENT

This doc ment des rib s an def i es the proces of refurbis ment of u ed medical imagin

eq ipment an a ples to the restorin of u ed medical imagin eq ipment to a con ition of

safety an ef fectivenes comp ra le to that of new eq ipment This restoration in lu es

action s c as re air, rework, software/hardware updates, an the re lacement of worn p rts

with original p rts This doc ment en merates the action that mu t b p rormed an the

man er con istent with prod ct sp cification an service proced res req ired to en ure that

the refurbis ment of medical imagin eq ipment is done without c an in the finis ed

medical imagin eq ipment’s p r orman e, saf ety sp cification , or inten ed u e ac ordin to

its original or a plca le val d registration

The f ol owin doc ments are ref er ed to in the text in s c a way that some or al of their

content con titutes req irements of this doc ment For dated referen es, only the edition

cited a ples For u dated ref eren es, the latest edition of the ref eren ed doc ment (in lu in

an amen ments) a pl es

ISO 13 8 :2 16, Med ic l d evic s – Qu l ity ma a eme t syst ems – Re uireme ts for

re ul at ory p rp ses

ISO 14 71:2 0 , Med ic l d evic s – Ap l i at ion of risk ma a eme t to med ical devic s

3 Terms and def initions

For the purp ses of this doc ment, the f ol owin terms an def i ition a ply

ISO an IEC maintain terminological data ases f or u e in stan ardization at the fol owin

ad res es:

• IEC Electro edia: avai a le at ht p:/ www.electro edia.org/

• ISO Onl ne browsin platf orm: avai a le at htp:/ www.iso.org/o p

3.1

e pe te s rvic l f e

time p riod sp cified by the man f acturer d rin whic the medical electrical eq ipment or

medical electrical s stem is exp cted to remain saf e f or u e (i.e maintain b sic saf ety an

es ential p r orman e)

Note 1 to e try: Mainte a c c n b n c s ary d rin th e p cte s rvic lfe

[SOURCE: IEC 6 601-1:2 0 /AMD1:2 12, 3.2 ]

3.2

inte de us

inte de purpos

u e f or whic a prod ct, proces , or service is intended ac ordin to the sp cification ,

in tru tion an information provided by the man facturer

Note 1 to e try: Inte d d u e s o ld n t b c nfu e with n rmal u e Whie b th in lu e th c n e t of u e a

inte d d b th ma uf acturer, inte d d u e fo u e o th me ic l p rp s whie n rmal u e in orp rate n t o ly

th me ic l p rp s , b t mainte a c , tra s ort, etc a wel

[SOURCE: IEC 6 601-1:2 0 /AMD1:2 12, 3.4 ]

3.3

ma uf acturer

natural or legal p rson with resp n ibi ty for the desig , man f acture, p c agin , la el n ,

as embl n , or ada tin medical imagin eq ipment, regardles of whether these o eration

are p r ormed by that p rson or on that p rson's b half by a third p rty

Note 1 to e try: ISO 13 8 :2 16 d fin s “la el n ” a “write , printe or gra hic mater a :

a) af fix d to a me ic l d vic or a y of its c ntain rs or wra p rs, or

b) a c mp n in a me ic l d vic ,

relate to id ntif i atio , te h ic l d s riptio , a d u e of th me ic l d vic , b t e clu in s ip in d c me ts In

this d c me t, th t material is d s rib d a markin s a d a c mp n in d c me t

Note 2 to e try: Ad ptin in lu e ma in s b ta tial mo if i atio s to me ic l ima in e uipme t alre d in u e

Note 3 to e try: In s me juris ictio s, th re p n ible ref urbis er c n b c n id re a ma ufa turer wh n

in olv d in th a tivitie d s rib d

Note 4 to e try: Ad pte f rom ISO 14 71:2 0 , 2.8

[SOURCE: IEC 6 6 1-1:2 0 /AMD1:2 12, 3.5 , modified – The definition an Note 2 have

b en reworded

3.4

me ic l ima ing e uipme t

medical electrical eq ipment that provides images for cl nical a plcation

Note 1 to e try: Se IEC 6 6 1 1:2 0 /AMD1:2 12, 3.6 f or a d finitio of me ic l ele tric l e uipme t

3.5

normal us

o eration, in lu in routine in p ction an adju tments by an o erator, an stan -by,

ac ordin to the in tru tion f or u e

Note 1 to e try: Normal u e s o ld n t b c nfu e with inte d d u e Whie b th in lu e th c n e t of u e a

inte d d b th ma uf acturer, inte d d u e fo u e o th me ic l p rp s whie n rmal u e in orp rate n t o ly

th me ic l p rp s , b t mainte a c , tra s ort, etc a wel

[SOURCE: IEC 6 601-1:2 0 /AMD1:2 12, 3.71]

3.6

operator

p rson han l n the medical imagin eq ipment

[SOURCE: IEC 6 6 1-1:2 0 /AMD1:2 12, 3.7 , modified – The definition has b en

reworded

3.7

ref urbis er

natural or legal p rson who con u ts refurbis ment of medical imagin eq ipment

3.8

patie t

l vin b in (p rson or animal) u dergoin a medical, s rgical or dental proced re

Note 1 to e try: A p tie t c n b a o erator

[SOURCE: IEC 6 6 1-1:2 0 /AMD1:2 12, 3.7 ]

3.9

set of inter related or interactin activities whic tran forms inputs into outputs

[SOURCE: IEC 6 6 1-1:2 0 /AMD1:2 12, 3.8 ]

3.10

ref urbis me t

proces or combination of proces es a pl ed d rin the exp cted service l f e to restore u ed

medical imagin eq ipment to a con ition of safety an ef fectivenes comp ra le to when

new

Note 1 to e try: Ref urbis me t c n in lu e a tivitie s c a re air, rework, re la eme t of worn p rts, a d

u d te of s f tware/h rdware b t s al n t in lu e a tivitie th t re ult in re ulatory s bmis io s

3.1

repair

me n for restorin to a safe, f un tional, normal con ition

[SOURCE: IEC 6 35 :2 14, 3.3 ]

3.12

rework

action taken on a non onformin prod ct so that it wi fulfi the sp cified Device Master

Record req irements b fore it is rele sed for distribution

[SOURCE: 21 CFR 8 0, 3 (x)]

3.13

ris

combination of the pro a i ty of oc ur en e of harm an the severity of that harm

[SOURCE: IEC 6 6 1-1:2 0 /AMD1:2 12, 3.10 ]

3.14

us d me ic l ima ing e uipme t

medical imagin eq ipment that has b en put into service

4 General re uirements f or ref urbishme t of use me ical devic s

Refurbis ment of u ed medical imagin eq ipment s al b con u ted u der a q alty

management s stem (QMS) of the refurbis er in compl an e with ISO 13 8 :2 16 In ad ition

to ISO 13 8 :2 16, the provision in p ragra h 4.2 to 4.1 s al b a pl ed

The ref urbis er s al determine, an provide adeq ate resources, in lu in trained an

q al fied p rsonal, maintained an cal brated eq ipment, an in tru tion , proced res, f iles,

record , or doc ments to p rf orm the ref urbis ment, as wel as an en ironment f or

refurbis ment that is in complete compl an e with the a pl ca le en ironmental, oc up tional

he lth an saf ety, an p st control req irements