Abstract
Design validation is a complex process in all kinds of industries but especially in the biomedical field due to the potential risks of using devices for interacting with organs and biological structures. The rapid manufacture of prototypes is an enormous help for carrying out validation trials; however, reaching preproduction stage in the case of biodevices is still complicated, as the normative environment is also multifaceted and several steps have to be followed.
As already explained, systematic validations throughout the whole development process, by using simulations and computer-aided engineering resources for in silico testing, rapid prototypes with increasing level of detail for in vitro trials and (only when working principles and safety have been verified) in vivo trials with animal models, are essential for reaching the preproduction stage.
In this chapter, we introduce the different kinds of procedures used for testing biodevices, providing examples of in silico, in vitro and in vivo testing and trying to detail some novel resources for more adequate validations, from workbenches and automated test systems to physical biomimetic models and virtual reality (VR) haptic devices.
Some commercial systems from relevant enterprises in their respective sectors are provided, as a help for researchers seeking novel, improved and secure ways of probing their biodevices and medical appliances, without directly resorting to the use of animal models. Important advices can also be obtained by consulting the most relevant related standards, which are also discussed. It is necessary to highlight again the importance of multidisciplinary teams in projects linked to the development of novel biodevices as, also for the different kinds of trials, abilities from physicians, surgeons, engineers and scientists are needed.
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References
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15.5.1 “New Approach” Directives Related to the Medical Industry
Directive 93/42/EEC related to “Medical devices”
Directive 90/385/EEC related to “Active implantable medical devices”
Directive 98/79/EC related to “Medical devices for “in vitro” diagnosis”
15.5.2 Standards Related to the Development of Medical Devices
ISO 10993 standard on “Biological evaluation of medical devices”
ISO 13485 standard on “Sanitary products. Quality management and regulatory affairs”
ISO 13488 standard on “Quality systems. Medical devices, sanitary products and especial requirements for applying ISO 9002 standard”
ISO 14971 standard on “Application of risk management to medical devices and sanitary products”
ISO 15223 standard on “Symbols used for labelling and information provided together with medical devices”
15.5.3 Additional Documents of Interest
Council of Europe “Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine” (1994)
UNESCO “Universal Declaration on the Human Genome and Human Rights” (1997) and “Guidelines for Implementation” (1999)
World Medical Association “Declaration of Helsinki. Ethical principles for medical research involving human subjects” (current revised edition 2008)
15.5.4 Some Interesting Related Websites
http://biomedical.materialise.com/anatomical-models. Accessed Mar 2013
http://biomedical.materialise.com/heartprint. Accessed Mar 2013
http://biomedical.materialise.com/other-anatomical-models. Accessed Mar 2013
http://simbionix.com. Accessed Mar 2013
http://worldwide.bose.com. Accessed Mar 2013
http://worldwide.bose.com/electroforce/en/web/home/page.html. Accessed Mar 2013
http://www.3bscientific.es. Accessed Mar 2013
http://www.cae.com/en/healthcare/home.asp. Accessed Mar 2013
http://www.ccmijesususon.com. Accessed Mar 2013
http://www.simulab.com. Accessed Mar 2013
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Lantada, A.D. (2013). In Silico, In Vitro and In Vivo Testing of Biodevices. In: Lantada, A. (eds) Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6789-2_15
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DOI: https://doi.org/10.1007/978-1-4614-6789-2_15
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