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International Journal of Bioprinting        Guide about the effects of sterilization on 3D-printed materials for medicine



               Given the biocompatibility and heat-resistance,   a practical point of view. This is in accordance with
            both  MED610  and  Surgical  Guide  resins  stand  as good   previous works . For instance, Msallem  et  al.  found
                                                                           [54]
                                                                                                      [55]
            options to produce surgical guides and positioning guides   that SLS PA12 is the most accurate material and has better
            in contact with mucous for less than 24 h (following   heat resistance when they compared the mechanical
            biocompatibility testing). MED610 has a good mechanical   performance of a 3D-printed dry human bony mandible,
            resistance after being sterilized by HPO and AU121, and   made of polyamide (PA) (SLS), White V4 resin (SLA),
            thus, it is a more solid option. This result is in line with   VERO (MJ), PLA (FFF) and four other binder jetting
            Gielisch et al.  who compared the behavior of polylactide/  materials, sterilized by different methods.
                      [46]
            polyhydroxyalkanoate (PLA/PHA) surgical guides printed   Additionally, it is important to highlight that PA12
            by FFF and MED610 guides printed by MJ in fully    is  commonly  used  in  surgical  guides  because  according
            guided dental implant placement before and after steam   to EN ISO 10993-1, PA12 is a material that is chemically
            sterilization, and the study found significant deviations in   and physically durable and biocompatible . However, it
                                                                                                 [56]
            angles and accuracy in the PLA/PHA guide as compared to   has a main drawback, which is the dust formed at where
            the MED610 guide. MED610 and Surgical Guide resin can   mechanical friction forces are applied.
            also be used for the production of custom-made medical
            devices to support treatments with materials needing skin   PA12 represents a good candidate of hard and
            or mucous contact for less than 24 h [47,48] .     resistant material for the production of patient-specific
                                                               cutting and positioning guides, as well as custom-made
               VERO and Durable, although do not have
            biocompatibility tested for mucous contact, are good   medical devices.
            alternatives to produce material that do not have to be   4.2. Tissue-material-mimicking comparison
            in contact with patients, such as anatomical models and   Producing anatomical models is a common application
            material for education and simulation purposes. Durable   of 3D printing in healthcare sector. These models are
            is normally used for low-friction assemblies and impact-  usually used for training, simulation or enhancing the
            resistant applications; however, very few information   comprehension and communication between patients
            regarding its biocompatibility and sterilization resistance   and clinicians. However, most of the present 3D-printable
            is provided by the manufacturer . VERO is used for the   materials are far from being mechanically comparable to
                                      [49]
            production of custom-made bone and tissue simulators,   the behavior of human tissues and therefore lack a certain
            such as the case presented by Lioufas et al. .     tactile realism. Figure 10 shows the comparison of different
                                             [50]
            4.1.3. Liquid resin flexible/elastic materials (SLA, MJ)  data obtained from different research papers [57-62]  with the
            SLA and MJ flexible materials such as Elastic Clear (MJ) or   mechanical properties of the 3D-printed materials used
            Elastic 50 and Flexible 80 (SLA) are normally used for the   in this work. The Surgical Guide resin material is the best
            production of anatomical models mimicking vessels or soft   material for mimicking hard tissues such as the bone.
            tissues . According to the presented results, overall, the   However, the analyzed materials were unable to mimic the
                 [51]
            elastic materials become harder after different sterilization   softness of tissues such as those in liver or heart. This means
            methods are applied. This is consistent with Told et al.    that for these tissues, it is necessary to find softer materials
                                                        [37]
            and Fuentes  et al. . Although the main application of   which have been previously analyzed by Tejo-Otero
                           [53]
                                                                   [62]
            elastic materials is the production of anatomical models   et al. . Figure 12 shows a comparison of Shore hardness
            for surgical training and education, most of them fail in   between the elastic materials shown in the present paper and
            mechanically mimicking the behavior of real human tissue   those in other studies, in which the Shore hardness of soft
            (Figure  10). Moreover, there is still a lack of mucous-  tissue has been investigated [62-65] . The Shore hardness values
            biocompatible  soft  materials,  which  could  have  an   of the elastic materials fall within the range of Shore A, while
            important impact on the improvement of patient-specific   those of the soft tissues fall within the range of Shore 00.
            temporary implants, such as stents.                This implies that, even if the mentioned materials are closer
                                                               to other materials in terms of hardness/softness, they are
            4.1.4. Powder polymeric material (SLS)             not the best materials used for mimicking soft tissues. This
            Powder polymeric materials printed using SLS technology   shows that in tissue-mimicking applications, other softer
            tend to have good resistance to heat. According to this   materials, such as hydrogels or silicones, must be used.
            work, PA12 could be sterilized following any of the
            studied sterilization processes (HPO, AU121, and AU134);   4.3. Contribution of the current work
            although few mechanical properties were affected, their   This current work presents practical testing complemented
            minor changes were not found to be significant from   with  a  literature  review, bringing  in new insights  into



            Volume 9 Issue 5 (2023)                        160                         https://doi.org/10.18063/ijb.756
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