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Liu J.,Shanghai Inspection and Testing Institute for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

Based on the current GB standard and IEC standard, some unique security risk points of the superconductive magnet were discussed and pointed, some security eigenvalue of widely used MRI were calculated, method and technology of the quench risk & protection were focused. Currently during the type test of superconductive MRI, the national standards and industry standards have not included items focus on superconductive magnet particularly, so this paper gives some recommended discussing and hopes to improve and enhance the future standard. Because superconductive MRI uses a large number of helium gas which is very short in China and if quenching, helium will evaporate quickly, so the helium recycling are also discussed.


Ding B.,Shanghai Inspection and Testing Institute for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2011

A great deal of comparisons on domestic standards for Orthopedic implants with ISO and ASTM standards have been presented, and some conclusions have been drawn: Domestic standards for orthopedic implants coincide with ISO and ASTM standards in the items of materials, geometry and classification. There are much bigger differences in some key performances of implants such as assembly, fatigue, wear and tear and so on. Some constructive ways have been suggested.


Huang J.,Shanghai Inspection and Testing Institute for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2011

The clinical failure factors of Orthopedic implants which happened recent years have been summarized. The main failure factors are quality of orthopedic implants itself, iatrogenic and patient-derived. The ways to preventive measures have been suggested.


Lin F.,Shanghai Inspection and Testing Institute for Medical Devices
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2013

The FE model of proximal humeral locking plate was established and analyzed to provide academic support of the proximal humeral locking plate failure. The stress distributions of the locking plate were observed under the situations of the fracture area providing support and without support. In summary, this type of locking plate cannot afford the stress at 120 degrees abduction position under the situation of fracture area provides without support. In order to reduce the probability of locking plate failure, it is recommended that using other type of locking plate instead or avoiding 120 degree abduction of the patient.


Wang C.-T.,Shanghai JiaoTong University | Jin Z.-M.,Xian Jiaotong University | Liao G.-S.,Shanghai JiaoTong University | Mao Y.-Q.,Shanghai JiaoTong University | And 4 more authors.
Yiyong Shengwu Lixue/Journal of Medical Biomechanics | Year: 2012

Objective: To investigate the wear mechanism of artificial hip joints and the criteria for wear life definition, analyze the causes of abnormal wear and the clinical manifestations of wear failure, establish the reasoning route of failure incidents. Methods: The wear process and early factors on abnormal wear in artificial hip joints were studied through elastohydrodynamic lubrication computation and finite element analysis; the service life of artificial hip joints was determined through establishing criteria for wear life definition; the clinical manifestations of wear failure were introduced and classified through wear-osteolysis morphological matrix; the reasoning logic of failure incidents was established through clinical investigation. Results: The minimal synovium thickness and contact stress between the femoral head and the acetabular cup were calculated, and the effect of relevant parameters was studied as theoretical references for wear analysis; the criteria on wear life definition of artificial hip joints were proposed, namely the mechanistic failure due to geometric change in artificial hip joints and the biological failure due to osteolysis; nine kinds of clinical manifestation for wear failure were found; the reasoning route for failure incidents was presented. Conclusions: Primary wear process in artificial hip joints includes boundary and mixed friction, adhesive, ploughing and third-body wear; surface quality, fit clearance between the acetabular cup and the femoral head, and roundness have great impact on early abnormal wear; normal mechanistic life of metal-UHMWPE artificial hip joint can reach 40 years, but its maximum biological life is no more than 10-15 years, which is the constraint of prosthesis life today; the diversity of clinical manifestations for wear failure is the morphological results of mechanical wear and osteolysis, which is helpful for the reasoning route of failure incidents.

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