RESUMO
Biological tests of medical devices is an important part to evaluate its biological safety. Good quality management of the test is a powerful guarantee to ensure the authenticity, integrity and reliability of the test results. This paper is based on the biological tests of medical devices, compares GLP and ISO/IEC 17025 which is widely used in China medical device testing institutions, describes the implementation of the GLP reference points to strengthen the quality management of biological tests of medical devices under the ISO/IEC 17025 system, to provide reference for quality management of medical device testing institutions.
Assuntos
Segurança de Equipamentos , Equipamentos e Provisões , China , Reprodutibilidade dos TestesRESUMO
Using alkali pretreatment can effectively remove residual variable-valence metals from non-metallic powder (WPCBP) in waste printed circuit boards. However, substantial amounts of waste lye are generated, which causes secondary pollution. On this basis, this study innovatively utilized waste alkali lye to prepare nano-magnesium hydroxide. When the dispersant polyethylene glycol 6000 was used at a dosage of 3 wt.% of the theoretical yield of magnesium hydroxide, the synthesized nano-magnesium hydroxide exhibited well-defined crystallinity, good thermal stability and uniform particle size distribution, with a median diameter of 197 nm. Furthermore, the in situ method was selected to prepare WPCBP/Mg(OH)2 hybrid filler (MW) and the combustion behavior, thermal and mechanical properties of PP blends filled with MW were evaluated. The combustion behavior of the PP/MW blends increased with the increasing hybrid ratio of Mg(OH)2, and the MW hybrid filler reinforced PP blends showed better thermal and mechanical properties compared to the PP/WPCBP blends. Furthermore, the dynamic mechanical properties of the PP/MW blends were also increased due to the improved interfacial adhesion between the MW fillers and PP matrix. This method demonstrated high economic and environmental value, providing a new direction for the high value-added utilization of WPCBP.
RESUMO
Reversible chemical covalency provides a path to materials that can degrade and recombine with appropriate stimuli and which can be used for tissue regeneration and repair. However, designing and preparing efficient and quickly self-healing materials has always been a challenge. The preparation strategies of photoresponsive gels attract a lot of attention due to their precise spatial and temporal control and their predetermined response to light stimulation. In this work, the linear copolymer PAC was synthesized via precipitation polymerization of acrylic acid and 7-(2-acrylate-ethoxylated)-4-methylcoumarin. The coumarin groups on the copolymer PAC side chains provide a reversible chemical cross-linking via photostimulation, which achieves reversible regulation of the gel network structure. The concentration of 18 wt% PAC solution produces gelation under irradiation with 365 nm. In contrast, PAC gel is restored to soluble copolymers under irradiation with 254 nm. Meanwhile, the mechanical and self-healing properties of the gel were also explored. It is demonstrated that the cracks of the gel can be repaired simply, quickly, and efficiently. Furthermore, the PAC copolymer shows an excellent adhesion property based on the reversible sol-gel transition. Thus, the PAC gel has considerable potential for applications in engineering and biomedical materials.
RESUMO
Poor interlaminar fracture toughness has been a major issue in glass fiber-reinforced epoxy resin (GF/EP) laminate composites. In this paper, soft carboxy-terminated nitrile (CTBN) rubber particles and rigid nano-SiO2 are used to toughen the epoxy resin (EP) matrix to improve the interlayer properties of GF/EP laminate composites. The effects of adding two toughening agents on the mechanical and interlayer properties of GF/EP laminates were studied. The results showed that adding the two kinds of particles improved the mechanical properties of the epoxy matrix. When the additional amount of flexible CTBN rubber particles was 8 wt%, and the rigid nano-SiO2 was 0.5 wt%, the fracture toughness of the matrix resin was increased by 215.8%, and the tensile strength was only decreased by 2.3% compared with the pure epoxy resin. On this basis, the effects of two kinds of particles on the interlayer properties of GF/EP composites were studied. Compared with the unmodified GF/EP laminates, the interlayer shear strength and mode I interlayer fracture toughness is significantly improved by a toughening agent, and the energy release rate GIC of interlayer shear strength and interlayer fracture toughness is increased by 109.2%, and 86.8%, respectively. The flexible CTBN rubber particles and rigid nano-SiO2 improve the interfacial adhesion between GF and EP. The cavitation of the two particles and the plastic deformation of the matrix is the toughening mechanism of the interlayer properties of the composite. Such excellent interlaminar mechanical properties make it possible for GF/EP laminates to be widely used as engineering materials in various industries (e.g., aerospace, hydrogen energy, marine).
RESUMO
This paper focuses on the characterization of the physico-chemical properties, surface modification, residual copper content and in situ hybrid inorganic particle modification of polypropylene (PP) composites reinforced by waste printed circuit board powder (WPCBP). A series of WPCBP/SiO2 hybrids (TSW) were prepared by a sol-gel method at different pH values. Characterization results revealed the in situ generation of SiO2 on the surface of WPCBP, and showed that with an increase in pH value, the size of SiO2 particles increased gradually and the copper content decreased in the TSW powder. The mechanical properties, oxidation induction time (OIT) and thermal properties of PP composites were improved by reinforcement with TSW, which might be ascribed to the formation of serrated interfaces. This work not only develops a powerful method to enhance the properties of PP/WPCBP composites, but also provides an environmentally sustainable approach to the high-added-value reutilization of WPCBP.
RESUMO
In this study, non-metallic materials of waste-printed circuit board powders (WPCBP) were successfully used as reinforcing filler to produce polypropylene (PP)â»wood composites, and their effect on the weathering properties of PP composites were fully evaluated via oxidation induction time (OIT), attenuated total reflectance Fourier-transform infrared spectroscopy (ATR-FTIR), differential scanning calorimetry, vicat softening point (VST), scanning electron microscopy, and mechanical properties analysis. The OIT analysis confirmed that the anti-thermal oxidative aging properties of PPâ»wood composites were decreased with the loading of WPCBP. Apart from that, the PP composite, reinforced with 30 wt.% of WPCBP, exhibited the highest value of active energy, which suggests that it is more sensitive to temperature and oxygen when compared with other PP composites. The mechanical properties analysis revealed that neat PP exhibited the poorest weathering properties after being subjected to UV exposure, and its retention rate of tensile strength and notched impact strength were only 70.6% and 59.6%, respectively, while WPCBP and wood flour (WF) could efficiently improve the retention rates of the mechanical properties of the PP composites when subjected to UV exposure. The visual appearance of the PP composites after being subjected to UV exposure showed more and smaller cracks with the loading of WPCBP and WF. The ATR-FTIR results revealed that the carbonyl index increased for all the weathered samples, and the more WPCBP was added into the PP composites led to a higher carbonyl index value, which might be due to the multivalent transition metals in WPCBP, which accelerate the photo-oxidation of the PP composites. The VST results show that both WPCBP and WF can effectively enhance the heat deformation resistance of the PP composites that have been subjected to UV exposure.