A development and biological safety evaluation of novel PVC medical devices with surface structures modified by UV irradiation to suppress plasticizer migration

2013 ◽  
Vol 101A (9) ◽  
pp. 2630-2643 ◽  
Author(s):  
Yuji Haishima ◽  
Kazuo Isama ◽  
Chie Hasegawa ◽  
Toshiyasu Yuba ◽  
Atsuko Matsuoka
Keyword(s):  
Uv Irradiation ◽  
Medical Devices ◽  
Safety Evaluation ◽  
Surface Structures ◽  
Biological Safety ◽  
Plasticizer Migration

scholarly journals Biological Safety Evaluation and Surface Modification of Biocompatible Ti–15Zr–4Nb Alloy

Materials ◽  
2021 ◽  
Vol 14 (4) ◽  
pp. 731
Author(s):  
Yoshimitsu Okazaki ◽  
Shin-ichi Katsuda
Keyword(s):  
Dental Implant ◽  
Safety Evaluation ◽  
Histopathological Analysis ◽  
Negative Effects ◽  
Biological Safety ◽  
Artificial Hip Joint ◽  
Artificial Hip ◽  
Pullout Load ◽  
Al2o3 Particles ◽  
Zr Alloys

We performed biological safety evaluation tests of three Ti–Zr alloys under accelerated extraction condition. We also conducted histopathological analysis of long-term implantation of pure V, Al, Ni, Zr, Nb, and Ta metals as well as Ni–Ti and high-V-containing Ti–15V–3Al–3Sn alloys in rats. The effect of the dental implant (screw) shape on morphometrical parameters was investigated using rabbits. Moreover, we examined the maximum pullout properties of grit-blasted Ti–Zr alloys after their implantation in rabbits. The biological safety evaluation tests of three Ti–Zr alloys (Ti–15Zr–4Nb, Ti–15Zr–4Nb–1Ta, and Ti–15Zr–4Nb–4Ta) showed no adverse (negative) effects of either normal or accelerated extraction. No bone was formed around the pure V and Ni implants. The Al, Zr, Nb, and Ni–Ti implants were surrounded by new bone. The new bone formed around Ti–Ni and high-V-containing Ti alloys tended to be thinner than that formed around Ti–Zr and Ti–6Al–4V alloys. The rate of bone formation on the threaded portion in the Ti–15Zr–4Nb–4Ta dental implant was the same as that on a smooth surface. The maximum pullout loads of the grit- and shot-blasted Ti–Zr alloys increased linearly with implantation period in rabbits. The pullout load of grit-blasted Ti–Zr alloy rods was higher than that of shot-blasted ones. The surface roughness (Ra) and area ratio of residual Al2O3 particles of the Ti–15Zr–4Nb alloy surface grit-blasted with Al2O3 particles were the same as those of the grit-blasted Alloclassic stem surface. It was clarified that the grit-blasted Ti–15Zr–4Nb alloy could be used for artificial hip joint stems.

Anticancer activity in vitro and biological safety evaluation in vivo of Sika deer antler protein

2017 ◽  
Vol 41 (6) ◽  
pp. e12421 ◽  
Author(s):  
Huihai Yang ◽  
Lulu Wang ◽  
Hang Sun ◽  
Xiaofeng He ◽  
Jing Zhang ◽  
...  
Keyword(s):  
Anticancer Activity ◽  
Sika Deer ◽  
Safety Evaluation ◽  
Deer Antler ◽  
Biological Safety

Nonclinical Safety Evaluation of Medical Devices

2018 ◽  
pp. 95-152
Author(s):  
Kathleen A. Funk ◽  
Victoria A. Hampshire ◽  
JoAnn C. L. Schuh
Keyword(s):  
Medical Devices ◽  
Safety Evaluation

scholarly journals Biological Safety Evaluation of 99mTc-DTPA-Ketoconazole for Diagnosis of Fungal Infection

2017 ◽  
Vol 2 (1) ◽  
pp. 1
Author(s):  
Maula Eka Sriyani ◽  
Hendris Wongso ◽  
Eva Maria Widyasari ◽  
Rizky Juwita Sugiharti ◽  
Iim Halimah ◽  
...  
Keyword(s):  
Single Dose ◽  
Fungal Infection ◽  
Radiochemical Purity ◽  
Safety Evaluation ◽  
Fungal Growth ◽  
In Vitro Assays ◽  
Toxic Response ◽  
Biological Safety ◽  
Safety Parameters

Infectious diseases have become one of the leading cause of mortality around the world, including in the Southeast Asia. One of the microbial that cause infection is fungi. Occasionally, deep-seated fungal infection is difficult to detect using conventional diagnosis methods and therefore leads to inaccurate detection. Our previous research was conducted in order to obtain the labeled compound of <sup>99m</sup>Tc-DTPA-Ketoconazole with a high radiochemical purity (98.40 ± 0.86%). Moreover, the in-vitro assays showed that <sup>99m</sup>Tc-DTPA-Ketoconazole can potentially bind to Candida albicans. On the other hand, in clinical routine use, diagnostic kit should be safe for the patients. Consequently, this research was conducted to determine the biological safety parameters of <sup>99m</sup>Tc-DTPA-Ketoconazole on the animal study, including single dose and acute toxicity test, sterility, and apirogenicity test. The results showed that both the single dose at 34.6 μCi and dose until 149 times of the single dose did not stimulate the toxic response to the animals. In addition, the sterility data revealed that there was no microbial growth after 7 days of incubation at 37°C as well as fungal growth after 14 days of incubation at 25°C. Furthermore, the apirogenicity test using rabbits revealed that there was no increase in temperature more than 0.6°C for each animal and not more than 1.5°C of total increase of temperature for all the animals. It is concluded that the <sup>99m</sup>Tc-DTPA-Ketoconazole is satisfy the requirements of biological safety of a radiopharmaceutical and therefore was acceptable for fungal detection in nuclear medicine.

In vivo biological safety evaluation of an iron-based bioresorbable drug-eluting stent

BioMetals ◽  
2020 ◽  
Vol 33 (4-5) ◽  
pp. 217-228
Author(s):  
Jianfeng Shi ◽  
Xuewen Miao ◽  
Haiyang Fu ◽  
Aili Jiang ◽  
YanFen Liu ◽  
...  
Keyword(s):  
Safety Evaluation ◽  
Drug Eluting Stent ◽  
Biological Safety ◽  
Drug Eluting ◽  
Iron Based
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