In e na ional Jou nal o Biop in ing
145
RESEARCH ARTICLE
Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
A s a e-o - he-a guide abou he e ec s o
s e iliza ion p ocesses on 3D-p in ed ma e ials
o su gical planning and medical applica ions:
Acompa a i e s udy
A nau Valls-Es e e1,2,3*, Pamela Lus ig-Gainza4, Nu ia Adell-Gomez1,3,
Ai o Tejo-O e o4, Ma i Englí-Rueda1,3, Es ibaliz Julian-Al a ez5,
Osmeli Na a o-Su eda5, Felip Fenollosa-A és4,6, Josep Rubio-Palau2,3,7,8,
Lucas K auel2,3,7, Josep Munue a2,3,9
1Inno a ion Depa men , Hospi al San Joan de Déu, Esplugues de Llob ega , Spain
2Medicina i Rece ca T anslacional, Facul a de Medicina i Ciències de la Salu , Uni e si a de
Ba celona, Spain
33D o Heal h Uni (3D4H), Hospi al San Joan de Déu, Uni e si a de Ba celona, Spain
4Cen e CIM, Uni e si a Poli ècnica de Ca alunya (CIM UPC), Ba celona, Spain
5S e iliza ion Depa men , Hospi al San Joan de Déu, Uni e si a de Ba celona, Spain
6Depa men o Mechanical Enginee ing, School o Enginee ing o Ba celona (ETSEIB), Uni e si a
Poli ècnica de Ca alunya, Ba celona, Spain
7Depa men o Pedia ic Su ge y, Hospi al San Joan de Déu, Uni e si a de Ba celona, Spain
8Maxillo acial Uni , Depa men o Pedia ic Su ge y, Hospi al San Joan de Déu, Uni e si a de
Ba celona, Spain
9Depa men o Diagnos ic Imaging, Hospi al San Joan de Déu, Uni e si a de Ba celona, Spain
(This a icle belongs o he Special Issue: Bio ab ica ion: The u u e o Medicine)
Abs ac
Su geons use di e en medical de ices in he su ge y, such as pa ien -speci ic
ana omical models, cu ing and posi ioning guides, o implan s. These de ices mus
be s e ilized be o e being used in he ope a ion oom. The e a e many s e iliza ion
p ocesses a ailable, wi h au ocla e, hyd ogen pe oxide, and e hylene oxide being
he mos common in hospi al se ings. Each me hod has bo h ad an ages and
disad an ages in e ms o mechanics, chemical in e ac ion, and pos - ea men
accu acy. The aim o he p esen s udy is o e alua e he dimensional and mechanical
e ec o he mos commonly used s e iliza ion echniques a ailable in clinical se ings,
i.e., Au ocla e 121, Au ocla e 134, and hyd ogen pe oxide (HPO), on 11 o he mos
used 3D-p in ed ma e ials ab ica ed using addi i e manu ac u ing echnologies.
The esul s showed ha he empe a u e (depending on he s e iliza ion me hod)
and he exposu e ime o ha empe a u e in luence no only he mechanical
beha io bu also he o iginal dimensioning planned on he 3D model. The e o e,
HPO is a be e o e all op ion o mos o he ma e ials e alua ed. Finally, based
on he esul s o he s udy, a ecommenda ion guide on s e iliza ion me hods pe
ma e ial, echnology, and clinical applica ion is p esen ed.
Keywo ds: Addi i e manu ac u ing; S e iliza ion; Ma e ials; Su gical planning;
3Dp in ing accu acy
*Co esponding au ho :
A nau Valls-Es e e
([email p o ec ed])
Ci a ion: Valls-Es e e A,
Lus ig-Gainza P, Adell-Gomez N,
e al., 2023, A s a e-o - he-a guide
abou he e ec s o s e iliza ion
p ocesses on 3D-p in ed ma e ials
o su gical planning and medical
applica ions: A compa a i e s udy.
In J Biop in , 9(5): 756.
h ps://doi.o g/10.18063/ijb.756
Recei ed: Janua y 03, 2023
Accep ed: Ma ch 01, 2023
Published Online: May 17, 2023
Copy igh : © 2023 Au ho (s).
This is an Open Access a icle
dis ibu ed unde he e ms o he
C ea i e Commons A ibu ion
License, pe mi ing dis ibu ion,
and ep oduc ion in any medium,
p o ided he o iginal wo k is
p ope ly ci ed.
Publishe ’s No e: Whioce
Publishing emains neu al wi h
ega d o ju isdic ional claims in
published maps and ins i u ional
a ilia ions.
In e na ional Jou nal o Biop in ing Guide abou he e ec s o s e iliza ion on 3D-p in ed ma e ials o medicine
146Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
1. In oduc ion
Addi i e manu ac u ing (AM) and h ee-dimensional (3D)
p in ing echnologies a e e olu ionizing manu ac u ing
indus ies by enabling he de elopmen o de ices and
p oduc s a he poin o demand in a unique way. The e
a e se en ca ego ies o AM echnologies acco ding o ISO/
ASTM 52900[1]: (i) a pho opolyme iza ion (VP), which
includes s e eoli hog aphy (SLA), digi al ligh p ocessing
(DLP), and olume ic 3D p in ing (3DVP); (ii) ma e ial
ex usion (ME), which includes used ilamen ab ica ion
(FFF) o used deposi ion modeling (FDM) and di ec
ink w i ing (DIW); (iii) ma e ial je ing (MJ); (i ) binde
je ing (BJ); ( ) powde bed usion (PBF), which includes
selec i e lase sin e ing (SLS) and selec i e lase mel ing
(SLM); ( i) di ec ed ene gy deposi ion (DED); and
( ii)shee lamina ion.
This e olu ion has been accele a ed due o he
COVID-19 pandemic and he supply sho ages in he
medical ield[2-6], u he popula izing he manu ac u ing
o pa ien -speci ic poin -o -ca e medical de ice. AM and
3D p in ing in heal hca e e e mainly o echnologies
ocused on gene a ing 3D physical objec s o p oduce
pe sonalized medical de ices ( om ana omical models o
pe sonalized splin s, ad anced medicines, o implan s)[7].
The gene a ion o pe sonalized ools o su gical planning
and medical aining models ha e become he main
applica ions o 3D p in ing echnologies[8]. In mos cases,
he p ocess is based on acqui ed images om a human
body, ypically aken om bo h compu ed omog aphy
(CT) and magne ic esonance imaging (MRI). An iden ical
copy, ob ained ei he om olume ende ing (VR) o 3D
compu e -aided design (CAD) models, o he clinical case
is an ad an age o cus omizing he su gical app oach[2,4,9].
In his p ocess, cus omized su gical ools and implan s can
be designed and p oduced[10-14]. These ools p in ed wi h
AM echnologies a e being apidly adop ed, bu mos o
he ma e ials used o p in ing he ools we e o iginally
designed o applica ions in o he (nonmedical) indus ies.
In medical applica ions, unc ional p oduc s a e subjec
o applica ion-speci ic mechanical loads, p essu e, e osion
and s ess, and a e exposed o chemicals and en i onmen al
ac o s limi ed o speci ic wo king and s o age condi ions.
Addi ionally, he ma e ials and manu ac u ing p ocesses
and he design o pa s depend no only on hei indica ion
o use and he ime o usage, bu also on he pe o mance
needed and he physical and chemical condi ions hey will
wo k in. Since May 2017, depending on hei indica ion
o use and isk, AM medical applica ions a e classi ied by
he Eu opean Union as Medical De ices egula ed unde
he Medical De ice Regula ion (MDR)[15]. Thus, each
applica ion is classi ied acco ding o i s isk and ime in
con ac wi h he pa ien . Fo example, an ana omical model
o su gical planning and aining is classi ied as Class I; a
cu ing guide o a posi ioning guide ( ha will be in sho
con ac wi h he pa ien ’s mucosa/body) is classi ied as
Class IIa, he same as a pa ien -speci ic acheo omy ube.
An implan able pla e will be a Class IIb, and a unc ional
implan , such as a knee implan , is classi ied as Class III.
Al hough he i s 3D p in ing o AM ma e ials es ed
and alida ed o medical use ha e appea ed in ecen
yea s, mos o he exis ing ma e ials a e no designed
and alida ed o ollow he hospi al s anda ds and MDR
compliance, no a e hei mechanical p ope ies analyzed
o he main s e iliza ion p ocesses used in hospi al se ings,
aking in o accoun hei indica ions o use[9,16-19]. Thus, i
is impo an o unde s and he e ec s o hese chemical
and p essu e p ocesses and how he mechanical p ope ies
o 3D-p in ed pa s a e a ec ed. All su gical ins umen s
a e cleaned and s e ilized be o e hey a e used. In some
applica ions, ce ain se s o ma e ials con aining su gical
aid ools and implan s a e cleaned and s e ilized se e al
imes pe day[20]. The e ec o s e iliza ion on mechanical
beha io and dimensional changes and dis o ion o
3D-p in ed pa s is key o unde s anding i s po en ial
applica ions and is he unde lying cause o ailu es[21].
S e iliza ion p ocess can be pe o med by wo di e en
ypes o known p ocesses[22]: (i) he mal s e iliza ion by
d y hea o s eam, also known as mois hea s e iliza ion
o au ocla e; (ii) low- empe a u e s e iliza ion, such as
chemical (wi h e hylene oxide o hyd ogen pe oxide) o
adia ion (ionizing o ul a iole [UV] adia ion). Mos
common s e iliza ion me hods a ailable in hospi als a e
s eam hea s e iliza ion (also known as au ocla e [AU]),
gas plasma (also known as hyd ogen pe oxide [HPO]
au ocla e), and e hylene oxide[23]. O he s e iliza ion
echniques ha e signi ican disad an ages o hei use in
hospi als. Fo ins ance, he mal s e iliza ion by d y hea
is a his momen banned om hospi als o he Eu opean
Union due o he inac i i y on p ions[24]. Then, adia ion
s e iliza ion, which is mainly used in he ood indus y as
well as in he medical de ice indus y, is no sui able o
hospi als[24]. E hylene oxide should be a oided o se e al
easons: (i) i changes he polyme s uc u es; (ii) i causes
molecula weigh loss; and (iii) i gene a es oxici y on he
su ace o he sample, o example, in polylac ic acid (PLA)
o polye hylene e eph hala e glycol (PETG)[25]. Unlike
he HPO low- empe a u e s e iliza ion, no oxic esidues
emain on he i ems ha ha e been s e ilized. Addi ionally,
his echnique is no only e ec i e and sa e bu also does no
equi e any ae a ion ime compa ed o e hylene oxide[24].
The ma e ials ha ha e been s udied so a include:
(i) PLA[24,26], ac yloni ile bu adiene s y ene (ABS)[27-30] o
In e na ional Jou nal o Biop in ing Guide abou he e ec s o s e iliza ion on 3D-p in ed ma e ials o medicine
147Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
he moplas ic polyu e hane (TPU)[31] using FDM (a ME
echnology); (ii) Den aGuide (Asiga)[32], Den al Su gical
Guide Ma e ial (Fo mlabs)[32-34] o Clea V02 (Fo mlabs)
using SLA (a VP echnology)[35]; and (iii) MED610 using
MJ echnology[33,34]. No da a on SLS (a PBF echnology)
ha e been ob ained ega ding he e ec o s e iliza ion
me hods in e ms o mechanical p ope ies, limi ed o only
3D p in ing accu acy[36]. A p esen , no s udy has been
pe o med o analyze he impac o s e iliza ion in a wide
ange o ma e ials o making su gical planning models
and su gical guides.
The e o e, he pu pose o his s udy is o e alua e
he dimensional and mechanical e ec o h ee o he
mos commonly used s e iliza ion echniques in clinical
se ings, i.e., Au ocla e 121, Au ocla e 134, and HPO,
on 11 o he mos used 3D-p in ed ma e ials using 3D
p in ing echnologies, such as FDM, SLA, SLS, and MJ. The
goal o he p esen s udy is o con ibu e a p ac ical guide
ega ding he ma e ials which may o may no be used o
each medical applica ion.
2. Ma e ials and me hods
This s udy e alua es he e ec s o di e en s e iliza ion
me hods (Au ocla e 121, Au ocla e 134 and HPO) on ou
di e en 3Dp in ing echnologies and 11 common AM
ma e ials used o he manu ac u e o 3D-p in ed su gical
guides, ana omical models, and o he cus omized medical
de ices. To do so, a li e a u e e iew and a mechanical
es ing s udy was pe o med. Figu e 1 shows he schema ic
o he p ocess in his s udy.
2.1. Ma e ials
All ma e ials used in his s udy, including he manu ac u e ’s
name, ci y and coun y o o igin, a e lis ed in Table 1.
2.2. 3D p in ing
In his sec ion, he di e en AM echnologies used a e
desc ibed wi h summa ies o he p in ing pa ame e s
needed o he manu ac u e o he 3D-p in ed samples.
Two ypes o samples we e manu ac u ed, one o ha d
ma e ials and he o he o so ma e ials, wi h di e en
specimens depending on he mechanical es s o be
pe o med. 3D-p in ed ensile samples ollowing he ISO
527 ype IA we e p oduced o all igid ma e ials. Fo elas ic
ma e ials, cylind ical elas ic samples (16 mm diame e ×
8mm heigh ) we e p in ed o Sho e ha dness es .
2.2.1. Fused deposi ion modeling
FDM is de ined as he con inuous deposi ion o a ilamen
o e a hea pla e laye -by-laye . The PLA, ABS and TPU
Figu e 1. Scheme o he p esen s udy.
In e na ional Jou nal o Biop in ing Guide abou he e ec s o s e iliza ion on 3D-p in ed ma e ials o medicine
148Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
samples we e manu ac u ed using Epsilon W50 (BCN3D,
Ba celona, Spain). The p in ing pa ame e s we e he same
o all ma e ials, i.e., a nozzle diame e o 0.4 mm, a laye
heigh o 0.1 mm, an in ill o 80%, an in ill o e lap o
15%, and a wall hickness o 0.8 mm. The samples we e
manu ac u ed ho izon ally.
2.2.2. S e eoli hog aphy
This p ocess is based on pho opolyme iza ion o esins
using UV lase o c ea e he laye s. Each laye is solidi ied
in x–y di ec ions and he building pla o m ises in z
di ec ion o c ea e he di e en laye s. Fo he manu ac u e
o Su gical Guide, Du able samples, Elas ic 50, and Flexible
80 samples, a Fo m 3BL (Fo mlabs, Massachuse s, USA)
was used a Ba celona Child en’s Hospi al San Joan de
Déu (HSJD). The samples we e manu ac u ed wi h an
angle o 20° om he building pla o m o inc ease p oduc
esis ance and acili a e pos p ocessing.
2.2.3. Selec i e lase sin e ing
SLS is a p ocess in which he 3D p in e uses a lase as bo h he
powe and hea sou ce o sin e powde ed ma e ial laye -by-
laye un il he 3D objec is manu ac u ed. Fo he manu ac u e
o he PA12 samples, a Ricoh AM S5500P was used a CIM
UPC acili ies, which has a laye hickness be ween 0.08 and
0.1 mm. The samples we e manu ac u ed ho izon ally.
2.2.4. Ma e ial je ing
MJ is based on pho opolyme iza ion o ma e ial je ed on o
he p in ing pla o m, whe e i is solidi ied by UV ligh
and he model is buil laye -by-laye . Fo he manu ac u e
o he MED610, VERO and Elas ic Clea samples, a J5
p in e was used a HSJD. The samples we e manu ac u ed
ho izon ally.
2.3. S e iliza ion me hod
To e alua e he c i ical e ec o s e iliza ion me hods
in 3D-p in ed, cus om-made medical de ices used in
hospi als, h ee o he mos used s e iliza ion p ocesses
a ailable in clinical se ings we e selec ed ollowing
clinically alida ed p o ocols. To compa e he e ec o he
di e en p ocesses, he p oduced specimens we e di ided
in o con ol and s udy g oups. Fo each ma e ial, h ee
specimens we e p in ed o each s e iliza ion me hod,
and h ee mo e specimens we e p in ed as con ols. The
sample size is conside ed app op ia e since he objec i e
is o demons a e he e ec o s e iliza ion on each
ma e ial, ins ead o demons a ing he exac mechanical
p ope y alue o each ma e ial (since he mechanical
p ope y alues o each ma e ial a e al eady gi en by he
manu ac u e s [Table 2] and se e al s udies ha e al eady
in es iga ed in his ega d o each ma e ial). Mechanical
esul s be ween s udies and manu ac u e s may a y due
o di e en es ing me hods used.
No s e iliza ion o disin ec ion p ocess was applied
o he con ol sample. The s udy g oup samples we e
subjec ed o h ee di e en s e iliza ion p ocedu es, i.e.,
HPO, Au ocla e 121, and Au ocla e 134, a ailable a a
s e iliza ion-ce i ied acili y a HSJD. All o hem we e
pe o med using machines om Ma achana (I aly). Those
me hods a e among he mos used o he s e iliza ion o
medical de ices. No all ma e ial samples we e subjec ed o
s e iliza ion me hods. The mel ing limi o each ma e ial,
Table 1. In o ma ion abou he ma e ial and he 3D p in ing echnology
P in ing
echnology
Ma e ial Vendo Ci y and coun y o o igin Sample Flexible/Elas ic Ins i u e esponsible
o p in ing
SLA Elas ic 50 Fo mlabs Massachuse s, USA Cylind ical Yes HSJD
SLA Flexible 80 Fo mlabs Massachuse s, USA Cylind ical Yes HSJD
SLA Du able Fo mlabs Massachuse s, USA Type 1A ISO 527 No HSJD
SLA Su gical Guide Fo mlabs Massachuse s, USA Type 1A ISO 527 No HSJD
MJ Elas ic Clea S a asys S a asys, Minneso a, USA Cylind ical Yes HSJD
MJ MED610 S a asys S a asys, Minneso a, USA Type 1A ISO 527 No HSJD
MJ VERO S a asys S a asys, Minneso a, USA Type 1A ISO 527 No HSJD
FDM ABS Kimya Nan es, F ance Type 1A ISO 527 No HSJD
FDM PLA Kimya Nan es, F ance Type 1A ISO 527 No HSJD
FDM TPU/TPE Rec eus Alican e, Spain Cylind ical Yes CIM UPC
SLS PA12 3D Sys ems Hemel Hemps ead, UK Type 1A ISO 527 No CIM UPC
Abb e ia ions: ABS, ac yloni ile bu adiene s y ene; CIM UPC, Cen e CIM o Uni e si a Poli ècnica de Ca alunya; FDM, used deposi ion modeling;
HSJD, Ba celona Child en’s Hospi al San Joan de Déu; MJ, ma e ial je ing; PLA, polylac ic acid; SLA, s e eoli hog aphy; SLS, selec i e lase sin e ing;
TPE, he moplas ic elas ome ; TPU, he moplas ic polyu e hane
In e na ional Jou nal o Biop in ing Guide abou he e ec s o s e iliza ion on 3D-p in ed ma e ials o medicine
149Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
which depends on i s glass ansi ion empe a u e (Tg),
can be known om he manu ac u ing echnical ile. The
s e iliza ion me hods pe o med o each ma e ial samples
can be ound in Table S1 (Supplemen a y File).
2.3.1. Hyd ogen pe oxide
HPO s e iliza ion is a low- empe a u e chemical
s e iliza ion p ocess ha uses HPO as he s e ilan . The
p ocess in ol es he ollowing s eps:
(1) P e acuum phase: Ai is emo ed om he
s e iliza ion chambe o p epa e o he in oduc ion
o HPO. This phase las s o 3–5 min.
(2) Pulse phase: A measu ed amoun o HPO is
in oduced in o he s e iliza ion chambe . The HPO
apo izes and begins o pene a e and s e ilize he
equipmen and con en s. This phase las s o 3–5 min.
(3) P essu e holding phase: The p essu e inside he
s e iliza ion chambe is main ained o a speci ied
pe iod o ime o allow he HPO o pene a e and
s e ilize he equipmen and con en s. This phase las s
o app oxima ely 30 min.
(4) Decon amina ion phase: The HPO is hen neu alized
and emo ed om he s e iliza ion chambe . This
phase las s o 10 min.
Du ing he HPO s e iliza ion cycle, he empe a u e
eaches 60°C, while he maximum p essu e eached is
a ound 69 kPa.
2.3.2. Au ocla e 121
Au ocla e 121 (AU121) is a p ocess ha uses a empe a u e
o 121°C o s e iliza ion. The s e iliza ion p ocess in ol es
he ollowing s eps:
(1) P ehea ing:
• Ai emo al: The ai inside he au ocla e is emo ed
h ough a acuum cycle, which helps o imp o e
s eam pene a ion. This s age las s o 2–5 min.
• S eam injec ion: S eam is in oduced in o he
au ocla e and he p essu e and empe a u e begin
o ise. This s age las s o 5 min.
(2) Holding ime: The empe a u e and p essu e a e
main ained a ound 121°C and 2.5–3 a m, espec i ely,
o 20 min. This is he ime equi ed o he s eam o
pene a e and kill any mic obial o ganisms.
(3) Dep essu iza ion: The p essu e inside he au ocla e
is educed back o a mosphe ic p essu e. This s ep
las s o 10 min.
(4) D ying: The i ems inside he au ocla e a e d ied.
This s age las s o 15 min.
The maximum p essu e eached is 2.5–3 a m, and he
empe a u e eached du ing he cycle is 121°C.
2.3.3. Au ocla e 134
Au ocla e 134 (AU134) is a p ocess ha uses a highe
empe a u e o s e iliza ion. The s e iliza ion p ocess
Table 2. Mechanical p ope ies and me hods used acco ding o manu ac u e o each ma e ial and 3D p in ing echnology used
Pa ame e s Manu ac u e Mechanical p ope ies acco ding o manu ac u e
Tensile
s eng h
(MPa)
Young’s
modulus
(MPa)
Elonga ion
a b eak
(%)
Glass ansi ion
empe a u e (Tg)
(°C)
Sho e
ha dness
Me hods
PLA (Manu ac u e ) Kimya 22.9 2.097 4.2 107 76.8D ISO 527-2/5A/50, ISO 178, ISO 868
ABS Kimya 35.3 1443 9.8 107 70.0D ISO 527-2/5A/50, ISO 178, ISO 868
TPU/TPE (Fila lex
60A P o)
Rec eus 26 2.5 950 – 63A DIN ISO 7619-1, DIN 53504-S2
PA12 3D Sys ems 43 1387 14 192 73D ASTM D638, ASTM D790, ASTM D2240
Elas ic 50 Fo mlabs 3.23 1.59 160 – 50A ASTM D 412-06 (A), ASTM 2240
Flexible 80 Fo mlabs 8.9 6.3 120 27 80A ASTM D 412-06 (A), ASTM 2240
Du able Fo mlabs 28 1000 55 – – ASTM D638-14, ASTM D 790-15
Su gical Guide Fo mlabs 73 2900 12.3 – 67D ASTM D790, ASTM D638
Elas ic Clea S a asys 3–5 – 360–400 – 45A ASTM D-412, ASTM D-395, ASTM D-2240
MED610 S a asys 50–65 2000–3000 10–20 54 86D ASTM D-638-03-04-05, D-790-04, DMA E
VERO S a asys 40–55 2000–2500 15–20 54 86D ASTM D-638-03-04-05, D-790-04, DMA E
Abb e ia ions: ABS, ac yloni ile bu adiene s y ene; PLA, polylac ic acid; TPE, he moplas ic elas ome ; TPU, he moplas ic polyu e hane
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150Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
in ol es he same s eps as AU121 bu wi h di e en
du a ion:
(1) P ehea ing:
• Ai emo al: he ai inside he au ocla e is emo ed
h ough a acuum cycle, which helps o imp o e
s eam pene a ion. This s age las s o 2–5 min.
• S eam injec ion: S eam is injec ed in o he
au ocla e and he p essu e and empe a u e begin
o ise. This s age las s o 5 min.
(2) Holding ime: The empe a u e and p essu e a e
main ained a ound 134°C and 2.5–3 a m, espec i ely,
o 4–5 min. This is he ime equi ed o he s eam o
pene a e and kill any mic obial o ganisms.
(3) Dep essu iza ion: The p essu e inside he au ocla e
is educed back o a mosphe ic p essu e. This s ep
las s o 10 min.
(4) D ying: The i ems inside he au ocla e a e d ied.
This s age las s o 15 min.
The maximum p essu e eached is 2.5–3 a m and he
empe a u e eached du ing he cycle is 134°C.
2.4. Tensile es ing
The ensile es s we e pe o med o he igid ma e ials wi h
Ins on 4507 a he EEBE-UPC (School o Enginee ing o
Ba celona Eas , a UPC acili y) using 3D-p in ed samples
ollowing he ISO 527 ype IA. Th ee con ol ensile es s
and h ee ensile es s o each s e iliza ion p ocess and
each ma e ial we e pe o med. De o ma ion measu emen s
we e made by Digi al Imaging Co ela ion (DIC) wi h he
Vic-Gauge 2D/3D so wa e. I uses op imized 2D and
3D co ela ion algo i hms o p o iding he eal- ime
displacemen and de o ma ion da a o mechanical es ing.
This can be seen as a se o i ual s ain gauges in which
da a can be ob ained o a ious poin s and plo ed in li e
e sus analog load inpu s. Then, esul s we e sa ed o each
poin examined, and comple e images s o ed o analysis in
bo h Vic-2D and Vic-3D (Figu e S1).
Fou digi al gauges ( ose e gauges) we e used o he
es s, wi h a ying dis ances be ween he gauges acco ding
o he ma e ial de o ma ion, and we e placed in he es
zone o he specimen. To ake he images and measu e he
de o ma ion, a Basle came a was used. Fo ha , Fuji ilm
lenses o 50 o 35 mm we e used and a ied acco ding
o he de o ma ion o he ma e ial (because i i de o ms
oo much, i comes ou o he came a). The samples
we e p epa ed as pe he s eps in he ollowing: (i) a
isual inspec ion was made; (ii) wi h a mic ome e , he
measu emen s o he specimens we e aken (see TableS1
in Supplemen a y File); and (iii) o place he gauges and
ensu e high accu acy in he measu emen , he specimens
we e pain ed in whi e colo and he e e ence poin ma ke s
(“li le black do s”) we e placed on he specimens o ensu e
con as and accu a e e e ences o scanning. In his way,
he digi al gauges ake he ini ial pa e n whe e hey a e
placed, and he spa ial e e ence on he specimen is e en i
he e is a lo o de o ma ion.
The pain ing did no a ec he esul s o he es s since
he pain ing was inished be o e he es was pe o med;
he e o e, no chemicals om he pain could in luence
he samples. Samples we e manually placed on he es ing
machine, and he es s we e pe o med a 3 mm/min speed
o all he ma e ials.
2.5. Sho e ha dness
Ha dness es s we e only pe o med on so ma e ials
wi h cylind ical specimens because he ha dness o hese
ma e ials could a y due o s e iliza ion. The du ome e
always p oduced he highes alue when he ha dness o
igid ma e ials was being measu ed. In e ms o he Sho e
ha dness es , he ATSM D2240—Du ome e Ha dness
me hod was ca ied ou . Fo ha , he Sho e du ome e
ype A (Baxlo, Ins umen os de medida y p ecisión S.L.,
Spain) was used o measu ing he ha dness o he di e en
samples. To ob ain mo e accu a e esul s, a s and a m
was used, and a du ome e suppo was designed and
ab ica ed. The ha dness alue was always measu ed a he
same le el o he s and a m, and h ee measu emen s we e
aken om each sample.
2.6. 3D p in ing accu acy
Fo he igid ma e ials, su ace compa ison o ensiles
be ween he di e en g oups (s e ilized and con ol) was
pe o med o analyze he dimensional changes since in
some ensiles; po en ial dimensional and geome ical
de o ma ions we e de ec ed once hey we e subjec ed o
s e iliza ion a high empe a u es o p essu es.
A CT scan o all ensiles was pe o med using a 1.5 T
Sys em MR-Philips in HSJD o ob ain he 3D digi alized
model o each p in ed ensile. Once he CT scan was
acqui ed, he esul ing DICOM (Digi al Imaging and
Communica ions in Medicine) images we e segmen ed o
ob ain he STL (S anda d Tessella ion Language) model
o each ensile. Using 3-Ma ic om Ma e ialise®, e e y
3D mesh o each s e ilized ensile was aligned o a con ol
ensile mesh (Figu e 2) and he poin cloud we e compa ed
by a poin cloud-based analysis.
The poin -based e alua ion o he 3D cloud meshes
in ol ed analyzing indi idual poin s wi hin he mesh in he x,
y, and z coo dina es. The ollowing s eps ou line he p ocess:
(1) Ob ain he 3D poin cloud mesh da a which includes
he x, y, and z coo dina e alues o each poin .
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(2) T ans o m he poin cloud da a in o he desi ed
e e ence ame (e.g., Wo ld Coo dina e Sys em
[WCS]) by applying a ans o ma ion ma ix.
(3) Compu e he dis ances be ween he poin s along he
x, y, and z axes.
(4) De e mine he a e age dis ance be ween he poin s.
(5) Each poin in he cloud had an RGB colo alue
assigned.
The ob ained ile in . x o ma o each analysis was hen
analyzed o ob ain he a e age dis ance (see Figu e S36).
3. Resul s
3.1. Mechanical es ing o he 3D-p in ed ma e ials
3.1.1. Polylac ic acid
Figu e 3 shows he mechanics es ing pe o med on
he 3D-p in ed PLA samples, wi h he g oup o samples
s e ilized by HPO and he con ol samples (no s e ilized)
being compa ed. O e all, i seems ha he HPO
s e iliza ion does no signi ican ly change he beha io o
he mechanical p ope ies o PLA. Table 3 shows di e en
mechanical p ope ies abou PLA wi h di e en me hods.
O he s e iliza ion me hods we e no es ed wi h PLA as
i s Tg is lowe (Table 2) han he empe a u e eached in
AU121 and AU134 s e iliza ion me hods.
3.1.2. Ac yloni ile bu adiene s y ene
Figu e 4 shows he mechanics o he 3D-p in ed ABS
samples s e ilized by HPO and he con ol samples. The
e ec o HPO s e iliza ion on he ABS samples was no
signi ican ly di e en when compa ed o he con ol
samples. The esul s showed di e ences below 10% in
elonga ion a b eak (8%) and ensile s eng h (2.4%)
be ween HPO samples and con ol samples. This means
ha he use o his me hod is e ec i e o i s use in su gical
planning. Table 4 shows di e en mechanical p ope ies o
ABS wi h di e en me hods.
3.1.3. MED610
Figu e 5 shows he mechanics o he con ol samples and
3D-p in ed MED610 samples s e ilized by HPO, AU121,
and AU134. Among he h ee di e en s e iliza ion
echniques, au ocla e has a bigge in luence on he
mechanical p ope ies in compa ison o HPO. A simila
ensile s eng h was ound be ween con ol samples and
HPO-s e ilized samples (wi h a di e ence o 0.64%),
al hough he e was a majo di e ence when compa ed
o bo h AU121 (17.40%) and AU134 (14.57%), showing
he AU134 esul s in highe ensile s eng h in samples
compa ed o he con ol samples. Table 5 shows di e en
mechanical p ope ies o MED610 wi h di e en me hods.
I can be no iced ha one specimen o AU134 has a
signi ican di e ence wi h espec o o he s specimens,
which can be a ibu ed o a p in ing de ec .
Figu e 2. P ealignmen be ween a MED610 con ol ensile (g ay) and a MED610 ensile ha was s e ilized wi h AU134 me hod (blue).
Figu e 3. PLA s e iliza ion compa ison. Da a a e ep esen ed as mean
alues. N = 3 PLA Con ol/g oup; N = 3 PLA HPO/g oup.
Table 3. Mechanical p ope ies o he 3D-p in ed PLA
Pa ame e s Mechanical p ope ies
Tensile s eng h (MPa) Young’s modulus (MPa) Elonga ion a yield (%) Elonga ion a b eak (%)
Con ol 21.85 ± 0.37 1568 ± 45 0.44 ± 0.74 4.18 ± 1.96
HPO 21.63 ± 1.2204 1408 ± 40 1.37 ± 0.10 4.11 ± 0.58
Da a a e ep esen ed as mean ± SD. N = 3 PLA Con ol/g oup; N = 3 PLA HPO/g oup.
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Figu e 4. ABS s e iliza ion compa ison. Da a a e ep esen ed as mean alues. N = 3 ABS Con ol/g oup; N = 3 ABS HPO/g oup.
Table 4. Mechanical p ope ies o he 3D-p in ed ABS
Pa ame e s Mechanical p ope ies
Tensile s eng h (MPa) Young’s modulus (MPa) Elonga ion a yield (%) Elonga ion a b eak (%)
Con ol 23.01 ± 1.32 1352 ± 53 1.73 ± 0.08 4.35 ± 0.85
HPO 23.57 ± 1.42 1271 ± 23 1.79 ± 0.12 4.73 ± 0.76
Da a a e ep esen ed as mean ± SD. N = 3 ABS Con ol/g oup; N = 3 ABS HPO/g oup.
Figu e 5. MED610 s e iliza ion compa ison. Da a a e ep esen ed as mean alues. N = 3 MED610 Con ol/g oup; N = 3 MED610 HPO/g oup; N = 3
MED610 AU121/g oup; N = 3 MED610 AU134/g oup.
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Table 5. Mechanical p ope ies o he 3D-p in ed MED610
Pa ame e s Mechanical p ope ies
Tensile s eng h (MPa) Young’s modulus (MPa) Elonga ion a yield (%) Elonga ion a b eak (%)
Con ol 26.26 ± 4.30 1375 ± 168 1.92 ± 0.15 8.82 ± 1.90
HPO 26.43 ± 0.82 1341 ± 43 1.92 ± 0.16 12.95 ± 3.55
AU121 21.69 ± 2.71 1201 ± 76 1.93 ± 0.19 12.14 ± 2.10
AU134 30.74 ± 2.75 1380 ± 145 1.33 ± 0.67 6.04 ± 5.55
Da a a e ep esen ed as mean ± SD. N = 3 MED610 Con ol/g oup; N = 3 MED610 HPO/g oup; N = 3 MED610 AU121/g oup; N = 3 MED610 AU134/g oup.
Figu e 6. VERO s e iliza ion compa ison. Da a a e ep esen ed as mean alues. N = 3 VERO Con ol/g oup; N = 3 VERO HPO/g oup; N = 3 VERO
AU121/g oup; N = 3 VERO AU134/g oup.
Figu e 7. Su gical Guide esin s e iliza ion compa ison. Da a a e ep esen ed as mean alues. N = 3 Su gical Guide esin Con ol/g oup; N = 3 Su gical
Guide esin HPO/g oup; N = 3 Su gical Guide esin AU121/g oup; N = 3 Su gical Guide esin AU134/g oup.
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160Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
Gi en he biocompa ibili y and hea - esis ance,
bo h MED610 and Su gical Guide esins s and as good
op ions o p oduce su gical guides and posi ioning guides
in con ac wi h mucous o less han 24 h ( ollowing
biocompa ibili y es ing). MED610 has a good mechanical
esis ance a e being s e ilized by HPO and AU121, and
hus, i is a mo e solid op ion. This esul is in line wi h
Gielisch e al.[46] who compa ed he beha io o polylac ide/
polyhyd oxyalkanoa e (PLA/PHA) su gical guides p in ed
by FFF and MED610 guides p in ed by MJ in ully
guided den al implan placemen be o e and a e s eam
s e iliza ion, and he s udy ound signi ican de ia ions in
angles and accu acy in he PLA/PHA guide as compa ed o
he MED610 guide. MED610 and Su gical Guide esin can
also be used o he p oduc ion o cus om-made medical
de ices o suppo ea men s wi h ma e ials needing skin
o mucous con ac o less han 24 h[47,48].
VERO and Du able, al hough do no ha e
biocompa ibili y es ed o mucous con ac , a e good
al e na i es o p oduce ma e ial ha do no ha e o be
in con ac wi h pa ien s, such as ana omical models and
ma e ial o educa ion and simula ion pu poses. Du able
is no mally used o low- ic ion assemblies and impac -
esis an applica ions; howe e , e y ew in o ma ion
ega ding i s biocompa ibili y and s e iliza ion esis ance
is p o ided by he manu ac u e [49]. VERO is used o he
p oduc ion o cus om-made bone and issue simula o s,
such as he case p esen ed by Liou as e al.[50].
4.1.3. Liquid esin lexible/elas ic ma e ials (SLA, MJ)
SLA and MJ lexible ma e ials such as Elas ic Clea (MJ) o
Elas ic 50 and Flexible 80 (SLA) a e no mally used o he
p oduc ion o ana omical models mimicking essels o so
issues[51]. Acco ding o he p esen ed esul s, o e all, he
elas ic ma e ials become ha de a e di e en s e iliza ion
me hods a e applied. This is consis en wi h Told e al.[37]
and Fuen es e al.[53]. Al hough he main applica ion o
elas ic ma e ials is he p oduc ion o ana omical models
o su gical aining and educa ion, mos o hem ail in
mechanically mimicking he beha io o eal human issue
(Figu e 10). Mo eo e , he e is s ill a lack o mucous-
biocompa ible so ma e ials, which could ha e an
impo an impac on he imp o emen o pa ien -speci ic
empo a y implan s, such as s en s.
4.1.4. Powde polyme ic ma e ial (SLS)
Powde polyme ic ma e ials p in ed using SLS echnology
end o ha e good esis ance o hea . Acco ding o his
wo k, PA12 could be s e ilized ollowing any o he
s udied s e iliza ion p ocesses (HPO, AU121, and AU134);
al hough ew mechanical p ope ies we e a ec ed, hei
mino changes we e no ound o be signi ican om
a p ac ical poin o iew. This is in acco dance wi h
p e ious wo ks[54]. Fo ins ance, Msallem e al.[55] ound
ha SLS PA12 is he mos accu a e ma e ial and has be e
hea esis ance when hey compa ed he mechanical
pe o mance o a 3D-p in ed d y human bony mandible,
made o polyamide (PA) (SLS), Whi e V4 esin (SLA),
VERO (MJ), PLA (FFF) and ou o he binde je ing
ma e ials, s e ilized by di e en me hods.
Addi ionally, i is impo an o highligh ha PA12
is commonly used in su gical guides because acco ding
o EN ISO 10993-1, PA12 is a ma e ial ha is chemically
and physically du able and biocompa ible[56]. Howe e , i
has a main d awback, which is he dus o med a whe e
mechanical ic ion o ces a e applied.
PA12 ep esen s a good candida e o ha d and
esis an ma e ial o he p oduc ion o pa ien -speci ic
cu ing and posi ioning guides, as well as cus om-made
medical de ices.
4.2. Tissue-ma e ial-mimicking compa ison
P oducing ana omical models is a common applica ion
o 3D p in ing in heal hca e sec o . These models a e
usually used o aining, simula ion o enhancing he
comp ehension and communica ion be ween pa ien s
and clinicians. Howe e , mos o he p esen 3D-p in able
ma e ials a e a om being mechanically compa able o
he beha io o human issues and he e o e lack a ce ain
ac ile ealism. Figu e 10 shows he compa ison o di e en
da a ob ained om di e en esea ch pape s[57-62] wi h he
mechanical p ope ies o he 3D-p in ed ma e ials used
in his wo k. The Su gical Guide esin ma e ial is he bes
ma e ial o mimicking ha d issues such as he bone.
Howe e , he analyzed ma e ials we e unable o mimic he
so ness o issues such as hose in li e o hea . This means
ha o hese issues, i is necessa y o ind so e ma e ials
which ha e been p e iously analyzed by Tejo-O e o
e al.[62]. Figu e 12 shows a compa ison o Sho e ha dness
be ween he elas ic ma e ials shown in he p esen pape and
hose in o he s udies, in which he Sho e ha dness o so
issue has been in es iga ed[62-65]. The Sho e ha dness alues
o he elas ic ma e ials all wi hin he ange o Sho e A, while
hose o he so issues all wi hin he ange o Sho e 00.
This implies ha , e en i he men ioned ma e ials a e close
o o he ma e ials in e ms o ha dness/so ness, hey a e
no he bes ma e ials used o mimicking so issues. This
shows ha in issue-mimicking applica ions, o he so e
ma e ials, such as hyd ogels o silicones, mus be used.
4.3. Con ibu ion o he cu en wo k
This cu en wo k p esen s p ac ical es ing complemen ed
wi h a li e a u e e iew, b inging in new insigh s in o
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161Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
he use o he mos clinically used s e iliza ion p ocesses
o he disin ec ion o he mos used AM ma e ials and
echnologies in he hospi al se ings. Some o he da a
p o ided he ein a e no a ailable om he ma e ial
p o ide s a he ime o he s udy, no published by
p e ious esea ch, as can be seen in Table 12. This wo k
also p o ides a p ac ical p oposal o po en ial applica ions
o cus om-made medical p oduc s o each ma e ial,
acco ding o he esea ch conduc ed on s e iliza ion
p ocesses and mechanical p ope ies.
As o he limi a ions o he s udy, i mus be s a ed
ha he po en ial e ec on mechanical p ope ies and
he mal beha io o di e en p in ing pa ame e s (in ill,
p in ing di ec ion, e c.) we e no in es iga ed in de ail,
no a ho ough s udy o he mechanical p ope ies o
each ma e ial was conduc ed. This wo k in ended o
demons a e he p ac ical easibili y o he p ope use o
3D-p in ed ma e ials in common heal hca e applica ions.
Mos o he mechanical p ope ies o each ma e ial can be
ound in da a shee s p o ided by each p o ide .
5. Conclusion
The g owing adop ion o 3D echnologies in medical
applica ions necessi a es he p ecise delinea ion o he
p ope ies and e ec s o s e iliza ion and wo king p ocesses
in he clinical and hospi al se ings on each ma e ial, as
well as he limi a ions in each o hei applica ions. I is
impo an o know when and o wha pu pose we can
make use o each ma e ial and AM echnology, and o
know he e ec s o empe a u e, s e iliza ion, chemicals
Figu e 12. Tissue–ma e ial compa ison in e ms o he Sho e ha dness ( anges 00 and A).
In e na ional Jou nal o Biop in ing Guide abou he e ec s o s e iliza ion on 3D-p in ed ma e ials o medicine
162Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756
and o he agen s on he inal medical p oduc o decide
how we should ea hem.
This pape can be used as a guide o u u e s udies
and as a guide o doc o s who a e s a ing o use AM
echnologies as well as s e iliza ion me hods. The e a e
se e al poin s ha mus be highligh ed:
(1) The empe a u e (depending on he s e iliza ion
me hod) and he exposu e ime in luence he
mechanical beha io o ma e ials. The highe he
empe a u e and he longe he exposu e ime,
hehighe he isk o he mechanical and geome ical
p ope ies o be a ec ed and he bigge he changes
om i s o iginal o m.
(2) The 3D p in ing accu acy showed ha AU134 and
AU121 me hods ha e a g ea e in luence on he samples
compa ed o HPO me hod. The e o e, HPO me hod is
a be e op ion, depending on he selec ed ma e ial.
(3) In gene al, ha d liquid esin ma e ials p oduced
by MJ such as MED610, o p oduced by SLA such
as Su gical Guide esin, and powde polyme ic
ma e ials p in ed using SLS echnology such as PA12
ha e be e beha io han he moplas ic ma e ials
p oduced by ME in hea -based s e iliza ion
p ocesses; he e o e, i is a be e op ion o he
p oduc ion o su gical guides. Among hese ha d
liquid esin ma e ials, MED610 and specially PA12
a e he s onges candida es.
(4) The selec ion o ma e ials, echnology, and
s e iliza ion p ocess o be used depends on he inal
applica ion and i s own mechanical and dimensional
equi emen s.
(5) The ma e ials analyzed in his s udy can mos ly
mimic ha d issues, owing o hei compa able elas ic
modulus. Howe e , o he ma e ials such as silicones
o hyd ogels a e needed o mimicking so issues.
Fo ma e ials whose su ace and geome y could be
po en ially a ec ed by he s e iliza ion p ocess, design
and dimensions o he inal pa s may play a ole in
manipula ing he desi ed mechanical p ope ies. Fo
s anda diza ion pu poses, he analysis o he p esen s udy
was based on he ISO ensile es ing. Ne e heless, u u e
wo k should be ocused on he analysis o he impac o
he design and he sample dimensions o each ma e ial o
be subjec ed o a s e iliza ion p ocess. Fo u u e s udies,
so e ma e ials such as silicones o hyd ogels could also be
included o analysis.
Acknowledgmen s
None.
Funding
The esea ch desc ibed in his pape was pa ially unded by
he p ojec named Qui o AM (Exp. COMRDI16-1-0011)
and unded by ACCIÓ om he Ca alan go e nmen and
ERDF om Eu opean Union.
Con lic o in e es
The au ho s decla e no con lic o in e es s.
Au ho con ibu ions
Concep ualiza ion: A nau Valls-Es e e, Pamela Lus ig-
Gainza, Ai o Tejo-O e o, Nu ia Adell-Gomez
In es iga ion:All au ho s
Me hodology: A nau Valls-Es e e, Pamela Lus ig-Gainza,
Nu ia Adell-Gomez, Ai o Tejo-O e o, Felip Fenollosa-
A és, Es ibaliz Julian-Al a ez, Osmeli Na a o-Su eda,
Josep Rubio-Palau, Lucas K auel, Josep Munue a
Fo mal analysis: A nau Valls-Es e e, Ai o Tejo-O e o,
Felip Fenollosa-A és, Josep Rubio-Palau, Lucas
K auel, Josep Munue a
W i ing – o iginal d a : A nau Valls-Es e e, Ai o Tejo-
O e o
W i ing – e iew & edi ing:All au ho s
E hics app o al and consen o pa icipa e
No applicable.
Consen o publica ion
No applicable.
A ailabili y o da a
Da a can be a ailable o eade s upon easonable eques .
Re e ences
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p inciples—Te minology. In O gan S and.
h ps://doi.o g/10.1520/ISOASTM52900-15
2. M. T. P. MATTHEW FOX, 2016, 3-D p in ing: Re olu ionizing
p eope a i e planning, esiden aining, and he u u e o
su gical ca e. Bull Am Coll Su g, 101(7):9–18.
h ps://bulle in. acs.o g/2016/07/3-d-p in ing-
e olu ionizing-p eope a i e-planning- esiden - aining-
and- he- u u e-o -su gical-ca e/ (accessed No . 30, 2022).
3. K auel L, Fenollosa F, Riaza L, e al., 2016, Use o 3D
p o o ypes o complex su gical oncologic cases. Wo ld J
Su g, 40(4): 889–894.
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