A state-of-the-art guide about the effects of sterilization processes on 3D-printed materials for surgical planning and medical applications: A comparative study

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: Acompa 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; 3Dp 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 × 8mm 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 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 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 TableS1 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 . 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 151Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 (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. 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 152Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 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. 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 153Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 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. 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 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 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 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, hehighe 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 1. ISO/ASTM, 2015, INTERNATIONAL STANDARD ISO / ASTM 52900 Addi i e manu ac u ing—Gene al 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. h ps://doi.o g/10.1007/s00268-015-3295-y 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 163Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 4. Tack P, Vic o J, Gemmel P, e al., 2016, 3D-p in ing echniques in a medical se ing: A sys ema ic li e a u e e iew. Biomed Eng Online, 1–21. h ps://doi.o g/10.1186/s12938-016-0236-4 5. Dodziuk H, 2016, Applica ions o 3D p in ing in heal hca e. Ka diochi u gia i To akochi u gia Polska/Polish. J Tho ac Ca dio asc Su g, 13(3): 283–293. h ps://doi.o g/10.5114/ki p.2016.62625 6. Kuno janek M, Wankm C, 2021, An analysis o he global addi i e manu ac u ing esponse o he COVID-19 pandemic. J Manu Technol Manag, 32(9): 75–100. h ps://doi.o g/10.1108/JMTM-07-2020-0263 7. Kalaska DM, 2022, 3D P in ing in Medicine, Woodhead P. Woodhead Publishing. 8. Tejo-O e o A, Buj-Co al I, Fenollosa-A és F, 2020, 3D p in ing in medicine o p eope a i e su gical planning: A e iew. Ann Biomed Eng, 48(2): 536–555. h ps://doi.o g/10.1007/s10439-019-02411-0 9. Ma coni S, Pugliese L, Bo i M, e al., 2017, Value o 3D p in ing o he comp ehension o su gical ana omy. Su g Endosc, 31(10): 4102–4110. h ps://doi.o g/10.1007/s00464-017-5457-5 10. Lee K, 2015, Accu acy o h ee-dimensional p in ing o manu ac u ing eplica ee h. Ko ean J O hod, 45(5): 217–225. 11. Rozema FR, Bos RRM, Boe ing G, e al., 1991, The e ec s o di e en s eam-s e iliza ion p og ams on ma e ial p ope ies o poly (L-lac ide). J Appl Bioma e , 2(1): 23–28 h ps://doi.o g/10.1002/jab.770020104 12. Cappello IA, Candela i M, Panone L, e al., 2022, 3D p in ed su gical guide o co ona y a e y bypass g a : Wo k low om compu ed omog aphy o p o o ype. Bioenginee ing, 9(5): 179. 13. Cos anzo R, Fe ini G, B unasso L, e al., 2022, The ole o 3D-p in ed cus om-made e eb al body implan s in he ea men o spinal umo s: A sys ema ic e iew. Li e, 12(4):489. 14. Co nejo J, Co nejo-Aguila JA, Va gas M, e al., 2022, Ana omical enginee ing and 3D p in ing o su ge y and medical de ices: In e na ional e iew and u u e exponen ial inno a ions. Biomed Res In , 2022: 6797745. h ps://doi.o g/10.1155/2022/6797745 15. ISO 13485:2016—Medical de ices—Quali y managemen sys ems—Requi emen s o egula o y pu poses. www.iso. o g (accessed No . 30, 2022). 16. Neches RY, Flynn KJ, Zaman L, e al., 2016, On he in insic s e ili y o 3D p in ing. Pee J, 4: e2661. h ps://doi.o g/10.7717/pee j.2661 17. ISO 11357-2, 1999, Plas ics—Di e en ial scanning calo ime y—Pa 2: De e mina ion o glass ansi ion empe a u e. 18. Kubyshkina G, Zupančič B, Š ukelj M, e al., 2011, S e iliza ion e ec on s uc u e, he mal and ime-dependen p ope ies o polyamides. In: P oulx T. (ed.), Mechanics o Time-Dependen Ma e ials and P ocesses in Con en io. 19. Sica d GK, Hayashi K, Manley PA, 2002, E alua ion o 5 ypes o ishing ,a e ial, 2 s e iliza ion me hods, and a c imp-clamp sys em o ex a-a icula s abiliza ion o he canine s i le join . Ve Su g, 31: 78–84. h ps://doi.o g/10.1053/j e .2002.30539 20. De Melo D, Kelly de Oli ei a L, Vicke y K, e al., 2018, Rep ocessing sa e y issues associa ed wi h complex-design o hopaedic loaned su gical ins umen s and implan s. Inju y, 49(11): 2005–2012. h ps://doi.o g/10.1016/j.inju y.2018.09.006 21. Geo ge M, A oom KR, Hawes HG, e al., 2017, 3D p in ed su gical ins umen s: The design and ab ica ion p ocess. Wo ld J Su g, 41(1): 314–319. h ps://doi.o g/10.1007/s00268-016-3814-5 22. Wallace CA, Wo ds K, 2016, New de elopmen s in disin ec ion and s e iliza ion. Am J In ec Con ol, 44(5): e23–e27. h ps://doi.o g/10.1016/j.ajic.2016.02.022 23. Pe ez MA, Block M, Espalin D, e al., 2012, S e iliza ion o FDM-manu ac u ed pa s. In 2012 in e na ional solid ee o m ab ica ion symposium. Uni e si y o Texas a Aus in. 285–296. h p://dx.doi.o g/10.26153/ sw/15350 24. O h O, Daucho C, O ellana M, e al., 2019, How o s e ilize 3D p in ed objec s o su gical use? An e alua ion o he olume ic de o ma ion o 3D-p in ed genioplas y guide in PLA and PETG a e s e iliza ion by low- empe a u e hyd ogen pe oxide gas plasma abs ac . Open Den J, 13(1): 410–417. h ps://doi.o g/10.2174/1874210601913010410 25. Modja ad K, Ebnesajjad S, Eds., 2014, Handbook o Polyme Applica ions in Medicine and Medical De ices, 354. 26. Chen JV, Tanaka K S, Dang ABC, e al., 2020, Iden i ying a comme cially-a ailable 3D p in ing p ocess ha minimizes model dis o ion a e annealing and au ocla ing and he e ec o s eam s e iliza ion on mechanical s eng h. 3D P in Med, 6: 1–10. 27. Popescu D, Baciu F, Vl D, e al., 2020, E ec s o mul iple s e iliza ions and na u al aging on he mechanical beha io o 3D-p in ed ABS. Mech Ma e , 148(Decembe 2019): 2020. h ps://doi.o g/10.1016/j.mechma .2020.103423 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 164Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 28. Aboame MA, Elgoha y DH, Almukil AA, e al., 2022, A compa a i e s udy o mechanical beha io o ABS ma e ial based on UVC s e iliza ion o medical usage. J Mech Sci Technol, 36(7): 3373–3385. h ps://doi.o g/10.1007/s12206-022-0616-6 29. Bosc R, To olano L, He san B, e al., 2021, Bac e iological and mechanical impac o he S e ad s e iliza ion me hod on pe sonalized 3D p in ed guides o mandibula econs uc ion. Sci Rep, 11(1): 1–10. h ps://doi.o g/10.1038/s41598-020-79752-7 30. Wong JY, P ahnl AC, 2014, 3D p in ing o su gical ins umen s o long-du a ion space missions. A ia Sp En Med, 85: 758–763. h ps://doi.o g/10.3357/ASEM.3898.2014 31. Ha yńska A, Gubanska I, Kucinska-Lipka J, e al., 2018, Fab ica ion and cha ac e iza ion o lexible medical- g ade TPU ilamen o Fused Deposi ion Modeling 3DP echnology. Polyme s (Basel), 10(12): 1304. h ps://doi.o g/10.3390/polym10121304 32. Pop SI, Dudescu M, Mihali SG, e al., 2022, E ec s o disin ec ion and s eam s e iliza ion on he mechanical p ope ies o 3D SLA- and DLP-p in ed su gical guides o o hodon ic implan placemen . Polyme s (Basel), 14(10): 2107. 33. Sha ma N, Cao S, Msallem B, e al., 2020, E ec s o s eam s e iliza ion on 3D p in ed biocompa ible esin ma e ials o su gical guides—An accu acy assessmen s udy. J Clin Med, 9(5): 1506. h ps://doi.o g/10.3390/jcm9051506 34. Chan M, Huang LG, Wu P, e al., 2021, S udy he design pa ame e s o 3D p in ing su gical guide de o ma ion quan i y by disin ec ion and s e iliza ion. J Ind P od Eng, 38(7): 499–507. h ps://doi.o g/10.1080/21681015.2021.1943719 35. Robles Lina es-Al elais HRS José A, Obed Figue oa-Ca azos J, Chuck-He nandez C, e al., 2018, Hyd os a ic high-p essu e pos -p ocessing o specimens ab ica ed by DLP, SLA, and FDM: An al e na i e o he s e iliza ion o polyme -based biomedical de ices. Ma e ials (Basel), 11: 2540. h ps://doi.o g/10.3390/ma11122540 36. Rouz F, Cade R, Na eau A, e al., 2022, Accu acy o comme cial 3D p in e s o he ab ica ion o su gical guides in den al implan ology. J Den , 117: 103909. h ps://doi.o g/10.1016/j.jden .2021.103909 37. Told R, Uj alusi Z, Pen ek M, e al., 2022, A s a e-o - he- a guide o he s e iliza ion o he moplas ic polyme s and esin ma e ials used in he addi i e manu ac u ing o medical de ices. Ma e Des, 223: 111119. h ps://doi.o g/10.1016/j.ma des.2022.111119 38. Rynio P, Galan K, Łukasz W, e al., 2022, E ec s o s e iliza ion me hods on di e en 3D p in able ma e ials o empla es o physician-modi ied ao ic s en g a s used in ascula su ge y—A p elimina y s udy. In J Mol Sci, 23: 1–13. 39. Popescu D, Baciu F, Vl D, e al., 2020, Mechanics o ma e ials e ec s o mul iple s e iliza ions and na u al aging on he mechanical beha io o 3D-p in ed ABS. Mech Ma e , 148: 103423. h ps://doi.o g/10.1016/j.mechma .2020.103423 40. Luchini K, Sloan SNB, Mau o R, e al., 2021, S e iliza ion and sani izing o 3D-p in ed pe sonal p o ec i e equipmen using polyp opylene and a single wall design. 3D P in Med, 7(1): 1–10. 41. Co é J J, Haggs om J, Vi ekanandan R, e al., 2020, COVID-19 and a no el ini ia i e o imp o e sa e y by 3D p in ing pe sonal p o ec i e equipmen pa s om compu ed omog aphy. 3D P in Med, 6(1): 1–12. 42. Spö k M, 2018, Op imisa ion o he mechanical p ope ies and p ocessing o polyp opylene and poly (lac ic acid) pa s p oduced by ex usion-based addi i e manu ac u ing, Ghen Uni e si y. 43. Głowacki M, Mazu kiewicz A, Słomion M, e al., 2022, Resis ance o 3D-p in ed componen s , es specimens and p oduc s o wo k unde en i onmen al condi ions—Re iew. Ma e ials (Basel), 15(17): 1–19. 44. Tö ök G, Gombocz P, Bogná E, e al., 2020, E ec s o disin ec ion and s e iliza ion on he dimensional changes and mechanical p ope ies o 3D p in ed su gical guides o implan he apy—Pilo s udy. BMC O al Heal h, 20(1): 1–12. h ps://doi.o g/10.1186/s12903-020-1005-0 45. S a asys, 2023, PolyJe ma e ials. h ps://www.s a asys.com/en/ma e ials/ma e ials-ca alog/ polyje -ma e ials/? il e =MT_PolyJe 46. Gielisch M, Heimes D, Thieme DGE, e al., 2022, S eam- s e ilized and deg adable used ilamen ab ica ion-p in ed polylac ide/polyhyd oxyalkanoa e su gical guides o den al implan s: A e hey accu a e enough o s a ic na iga ion? In J Biop in , 9(2). h p://dx.doi.o g/10.18063/ijb. 9i2.655 47. Zhu WY, Su YX, Pow EHN, e al., 2021, ‘Th ee-in-one’ pa ien -speci ic su gical guides o simul aneous den al implan s in ibula lap jaw econs uc ion: A p ospec i e case se ies. Clin Implan Den Rela Res, (23): 43–53. h ps://doi.o g/10.1111/cid.12954 48. Schwa zkop R, Fe nandez E, Buckland A, e al., 2019, Feasibili y o single-use 3D-p in ed ins umen s o o al knee a h oplas y. Bone J J, (101): 115–120. h ps://doi.o g/10.1302/0301-620X.101B7.BJJ-2018-1506. R1 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 165Volume 9 Issue 5 (2023) h ps://doi.o g/10.18063/ijb.756 49. Fo mlabs, Resin o pliable p o o yping. h ps:// o mlabs-media. o mlabs.com/da ashee s/1801084- TDS-ENUS-0P.pd 50. Liou as PA, Hons M, Quayle MR, e al., 2016, 3D p in ed models o cle pala e pa hology o su gical educa ion. Plas Recons Su g Glob Open, 4(9): 1–6. h ps://doi.o g/10.1097/GOX.0000000000001029 51. Aima A, Pale mo A, Innocen i B, 2019, The ole o 3D p in ing in medical applica ions: A s a e o he a . J Heal hc Eng, 5340616. h ps://doi.o g/10.1155/2019/5340616 52. Bosc R, To olano L, He san B, e al., 2021, Bac e iological and mechanical impac o he S e ad s e iliza ion me hod on pe sonalized 3D p in ed guides o mandibula econs uc ion. Sci Rep, 11: 581. h ps://doi.o g/10.1038/s41598-020-79752-7 53. Fuen es JM, A ie a MP, Bo ona T, 2022, E ec s o s eam hea and d y hea s e iliza ion p ocesses on 3D p in ed comme cial polyme s p in ed by used deposi ion modeling. Polyme s (Basel), 14(855): 855. 54. Zuni a M, Make iha a IGBN, I awan i R, 2022, 3D p in ed polye he e he ke one (PEEK), polyamide (PA) and i s e alua ion o mechanical p ope ies and i s uses in heal hca e applica ions. IOP Con Se Ma e Sci Eng, 1224: 0–8. h ps://doi.o g/10.1088/1757-899X/1224/1/012005 55. Msallem B, Sha ma N, Cao S, e al., 2020, E alua ion o he dimensional accu acy o 3D-p in ed ana omical mandibula models using. J Clin Med, 9(3): 817. 56. Raza iye MK, Ta i RA, Khajehmohammadi M, 2022, SLS 3D p in e : An expe imen al app oach. CIRP J Manu Sci Technol, 38: 760–768. h ps://doi.o g/10.1016/j.ci pj.2022.06.016 57. Chen YW, Moussi J, D u y JL, e al., 2016, Zi conia in biomedical applica ions. Expe Re Med De ices, 13(10): 945–963. h ps://doi.o g/10.1080/17434440.2016.1230017 58. Xing H, Zou B, Li S, e al., 2017, S udy on su ace quali y, p ecision and mechanical p ope ies o 3D p in ed Z O2 ce amic componen s by lase scanning s e eoli hog aphy. Ce am In , 43(18): 16340–16347. h ps://doi.o g/10.1016/j.ce amin .2017.09.007 59. Kassab GS, Sacks MS, 2016, S uc u e-based mechanics o issues and o gans. 60. Abbo RD, Kaplan DL, 2015, S a egies o imp o ing he physiological ele ance o human enginee ed issues. T ends Bio echnol, 33(7): 401–407. h ps://doi.o g/10.1016/j. ib ech.2015.04.003 61. Gu Q, Tomasko ic-C ook E, Lozano R, 2016, Func ional 3D neu al mini‐ issues om p in ed gel‐based bioink and human neu al s em cells. Ad Heal hc Ma e , 5(12): 1429–1438. 62. Tejo-O e o A, Fenollosa-A és F, Achae andio I e al., 2022, So - issue-mimicking using hyd ogels o he de elopmen o phan oms. Gels, 8(1): 40. h ps://doi.o g/10.3390/gels8010040 63. Yoon YC, Lee JS, Pa k SU, e al., 2017, Quan i a i e assessmen o li e ib osis using sho e du ome e . Ann Su g T ea Res, 93(6): 300–304. 64. Es e mann SJ, Pah DH, Reisinge A, 2020, Quan i ying ac ile p ope ies o li e issue, silicone elas ome s, and a 3D p in ed polyme o manu ac u ing ealis ic o gan models. J Mech Beha Biomed Ma e , 104: 103630. 65. Tejo-O e o A, Lus ig-Gainza P, Fenollosa-A és F, e al., 2020, 3D p in ed so su gical planning p o o ype o a bilia y ac habdomyosa coma. J Mech Beha Biomed Ma e , 109:103844.