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in vivo Testing
Published in Claudio Migliaresi, Antonella Motta, Scaffolds for Tissue Engineering, 2014
Milena Fini, Nicolò Nicoli Aldini, Paola Torricelli
The ISO is a worldwide federation of national standards bodies, whose task is to draft the international rules for a variety of technical subjects and applications. Among the International Standards, the ISO 10993 refers to the fundamental principles governing the biological evaluation of medical devices.16 The definition of categories of devices is mainly based on the nature and duration of the contact with the body, and the selection of appropriate tests is performed consequently. Well-trained and experienced professionals should apply ISO tests with interpretation and judgement. The factors relevant to the material, its expected applications and the current knowledge provided by scientific literature as previous clinical experience must be considered. In particular, the biocompatibility tests must be performed on materials and the final products, taking into account the type, duration and conditions of the exposure in the human body, the physical and chemical features of the product, the toxicological activity of the chemical elements or compounds and the presence of leachable materials.
Biocompatibility
Published in Richard C. Fries, Handbook of Medical Device Design, 2019
ISO is in the process of publishing a series of standards on the biological evaluation of medical devices—ISO 10993. Many parts of this series have been accepted as international standards, while the rest are under development (see Table 16-3). The subject of the first part, ISO 10993-1, is the categorizing and performance of safety testing. Part 2 of the standard, ISO 10993-2, is concerned with animal welfare requirements; another section, ISO 10993-12, deals with sample preparation and reference materials. Most of the remaining parts of the standard treat the individual tests.
Biomaterials and Material Testing
Published in Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, 2018
Paul H. King, Richard C. Fries, Arthur T. Johnson
ISO 10993 is a series of standards on the biological evaluation of medical devices (see Table 10.3). The subject of the first part, ISO 10993-1, is the categorizing and performance of safety testing. Part two of the standard, ISO 10993-2, is concerned with animal welfare requirements; another section, ISO 10993-12, deals with sample preparation and reference materials. Most of the remaining parts of the standard treat the individual tests.
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
ISO is an independent, nongovernmental, international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges. It consists of 250 Technical Committees (TCs) and defines the scope of each TC [22]. In the medical device industry, for example, ISO/TC 210 ‘Quality management and corresponding general aspects for medical devices’ develops standards such as ISO 13485 ‘Medical devices – Quality management systems – Requirements for regulatory purposes’ and ISO 14971 ‘Medical devices – Application of risk management to medical devices.’ ISO/TC 194 ‘Biological and clinical evaluation of medical devices’ develops standards such as ISO 10993–1 ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’ and ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice.’ Further, ISO/TC 106 ‘Dentistry,’ ISO/TC 121 ‘Anesthetic and respiratory equipment,’ etc. develop many standards related to medical devices.
Compatibility and durability of the gel stent material
Published in Expert Review of Medical Devices, 2022
Vanessa Vera, Arsham Sheybani, William Wustenberg, Laszlo Romoda, Larissa Camejo, Xiongfei Liu, Richard Lewis
A variety of biocompatibility tests were performed to characterize the long-term and short-term profile of the stent. This preclinical testing was conducted in compliance with International Standard ISO 10993–1 [11]; the standardized biological evaluation of medical devices, including the evaluation and testing within a risk management process. This guides the classification of a device according to how it is in contact with a patient, what the potential risks are, what testing is necessary, and the results of those assays demonstrated that the materials were appropriate and would not show adverse effects.
Graphene in wearable textile sensor devices for healthcare
Published in Textile Progress, 2022
Md Raju Ahmed, Samantha Newby, Wajira Mirihanage, Prasad Potluri, Anura Fernando
There is a requisite for the biological interface to be closely connected in real-time medical applications, so the wearable medical device must not create additional health threats and inconveniences that may restrict daily activities. Biocompatibility between the human body and the wearable sensor is key to preventing several difficulties, such as adverse immune reactions (Ponraj, Kirthika, Lim, & Ren, 2018). Additionally, the ISO 10993 family of standards and ISO 13485 both offer required standards for biocompatibility within medical devices and the manufacturing environments that the device and material should satisfy the relevant standards (Morris & Murray, 2020). It has been reported that needle-like CNTs can cause asbestos-like pathogenicity when injected in large amounts into the lungs of mice (Poland et al., 2008). Therefore, for future applications of nanostructured materials, a deeper understanding of the immune responses and a definition of the exposure criteria under individual circumstances, such as skin contact, uptake, inhalation, and injection, are essential. GaN is both biocompatible, and an ideal choice for applications in high-speed electronic and optoelectronic equipment (Podolska et al., 2012) and therefore is suggested as the base for many biocompatibility biosensors. Recently, Rogers et al. proposed a silicon-based multifunctional brain sensor and several immunohistochemical studies on brain tissue after implantation, two, four, and eight weeks, showing that the sensor and its by-products were released in the brain cavity were fully biocompatible (S.-K. Kang et al., 2016). Consequently, this traditional semiconductor can be used for biomedical implants and health surveillance. Several other organic active substances, such as poly(3,4-ethylenedioxythiophene) (PEDOT) and polypyrrole (PPy) have shown biocompatibility and can be used for monitoring photoactive substances (W. Zhou, Guan, Sun, Xing, & Zhang, 2019).