[Study on Testing Methods of Pen-injector's Dosing Accuracy].

Objective: An accuracy test method is proposed to reduce the amount of reagents used in the test and reduce the cost of spot checks and self-tests.

Methods: According to the requirements of dose accuracy test in standard atmospheric conditions in ISO 11608-1:2014, dose accuracy test is carried out for the same batch of reusable pen injector samples by using the test method proposed in this paper and the test method in relevant foreign research, and the data measured by the two methods are processed.

Results: After experimental testing and analysis, the data measured by the two methods did not exceed the dose accuracy limit specified in the ISO standard.

[Research on Mathematical Distribution of Failure Time and Engineering Evaluation for Medical Electrical Equipment Based on Operation and Maintenance Data].

This study mainly discusses the contents, methods and characteristics of the collection of operation and maintenance data, as well as the establishment and evaluation methods of the distribution model of the failure time of medical electrical equipment. The distribution models of failure time at three levels of medical electrical equipment are established by linear regression method and goodness of fit test:The first is the device level MTBF distribution model, the second is the failure rate distribution model of the failure mode of key components, the third is the calculation model of the influence coefficient of influence factor on the failure mode of key components. This study presents a method of establishing MTBF segment model and implements a calculation model of influence coefficient varying with time.

[Study on Feasibility and Countermeasures of Social Third-party EMC Testing for Medical Device Registration].

In view of the background that the regulation of medical device supervision and management is about to cancel the registration and inspection, this paper analyses the risk of electromagnetic compatibility of medical devices, combs the current situation of electromagnetic compatibility testing, discusses the factors to be considered in the approval of third-party testing reports, and gives relevant solutions suitable for China's national conditions.

[Discussion and Suggestion on Revision Basis of YY 0505 Standard].

In order to coordinate with the overall conversion progress of IEC 60601-1, the third edition of the General Standard for Electrical Safety of Medical Electrical Equipment, this paper compares the differences between the two editions in the world and the current edition in China, and analyses the quotation of IEC 60601 series standards, and then discusses the advantages and disadvantages of the conversion of the two editions. Finally, some suggestions for revision of the third edition of the standard are given, which is suitable for China's national conditions.

[Musculoskeletal System Anatomic Database Software Applied to the Internet].

We developed a new the musculoskeletal anatomic database software based on internet. This article presents the design objective and basic routes of the software, further present the technical plan, software functionality and service objects. This software is used to store the anatomic data of musculoskeletal system, that allows the users to enquire and do statistial analysis through the large amount of anatomic data, that guides the doctors to design operative schemes, that provides technical supports for medicine and industry fields.

[Exploration of Domestic Medical Electrical Equipment Reliability Promotion Method].

The reliability of domestic medical equipment is one of the main factors that restrict the competitiveness of domestic medical devices. It is also an important factor that endangers the safety of patients and a blind spot in safety risk management. By analyzing the core elements of reliability and the situation of domestic medical device industry, this paper sorts out and analyzes the problems existing in the reliability of medical device industry, and puts forward the key points and problems to be solved to improve the reliability of domestic medical equipment products.

[Simulation Study on Radiated Immunity Test of Active Implantable Medical Device].

In the electromagnetic compatibility standards of active implantable medical devices such as ISO 14117,radiated immunity test above 450 MHz frequency is recommended to be carried out in the electromagnetic shielding room.However,different test locations and the shape/size of the shielding room may lead to very different electromagnetic field distribution in the radiation exposure area of the sample,thus affecting the consistency of the test.With the model built by COMSOL software,this paper analyzes the impact of different parameters,such as size of the room and position of torso simulator on the distribution of field intensity,and reaches results about the distribution of field intensity on the torso simulator area under tow sizes of shielding rooms and two typical test positions.

[Analysis of the Electromagnetic Compatibility Standard for Active Implantable Medical Devices Using in the Heart].

In this paper,standards for active implantable cardiac medical devices are discussed.Potential EMC risks and its correspondent tests settings as well as the design principle of the tests have been analyzed.The problems arises from the difference between domestic and international standards on the limitation of exposure of the general public to electromagnetic fields and the lack of assessment of EMC risk which generated by the the 5th generation mobile communication for the impact on the active implantable devices devices.

[A Torso Simulator Design for Implantable Nerve Stimulator Test].

This paper introduces ISO 14708-3:2017, the new edition of the international standard for implantable neurostimulator, and emphasizes the new requirements in the clause of protection from RF electromagnetic interference. To meet this new requirements, this paper presents a design of torso simulator for the testing of implantable neurostimulator. The design includes volume conductor, electrodes and grids, which can simulate the actual operating environment of implantable neurostimulator in RF electromagnetic interference testing.

[Research on Field Strength of Radiated Immunity Test for Active Implantable Medical Devices].

In order to compare the radiation immunity test level of ISO 14708 series standards and the domestic and international environmental radiation standards and then to ascertain whether the radiated immunity test level has reached the limit of the radiation strength in the relevant radiation environmental standards, this paper calculated the radiation field intensity and power density according to the radiated immunity test of ISO 14708 standards, and compared with the limit of ICNIRP 1998 and GB 8702-2014.

[Design of EMC Test System for Implantable Cardiac Pacemakers and Implantable Cardioverter Defbrillators].

This paper reviews the basic function and principle of the implantable cardiac pacemakers and implantable cardioverter defibrillators, also reviews the resemblances and differences between them in terms of electromagnetic compatibility (EMC). There is analysis and classification on the EMC test set up defined by the section 27 of the international standards ISO 14708-2:2005 and ISO 14708-6:2010. A new EMC test set up design is proposed for some tests defined by section 27 of the international standards.

[Development of Monitoring System for Infant Incubator Based on IOT Technology].

IOT(Internet of things) is a relatively new technology, more and more integrated into our lives. In this paper we use infant incubator for example, introduce the application of IOT technology to reduce the risk of the use of medical devices, and through the dynamic management to improve the management level and efficiency. Put forward a method of medical equipment linked.

[Development and Application of the Kinematic Database Software of Lower Limbs Based on Internet].

In current study, we develop a new kinematic database software for lower limbs based on internet. This article present technical features as well as functions of the software, further present the development idea and working process. This software can be used to store kinematic data of lower limbs in any motion state, and take data statistics, from macro perspectives, it works for doctors to improve the clinical treatment level and rehabilitation training, evaluate the motion ability of lower limb of patient, help industry and medical device manufacturers with lower limb prosthesis design, it also can provide technical support to the production's ergonomic design.

[Finite Element Analysis of Biodegradable Polylactic Acid Stent].

Biodegradable vascular stent, also known as the third generation stent, has recently been widely studied. Finite element models of three stents with the same structure and different specifications were developed. The mechanical behavior under crimping, expanding and fatigue testing were assessed by von Mises yield and Goodman convergence.

[The uncertainty of different vickers-hardness test force in medical device testing].

Vickers hardness is widely used in the performance testing of the metallic medical devices. It discusses the relationship between different test force and the uncertainty by mathematical simulation and experiment. With the increase of test force its uncertainty becomes smaller at 400 times magnification.