[Difference Analysis of System Accuracy Criteria between Self-Monitoring Blood Glucose Test System and Point-of-Care Blood Glucose Monitoring Systems].

According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs.

[Researching on the Classification of Computer Aided Diagnosis/Detection Software].

Based on the developing situation of Computer Aided Diagnosis/Detection (CAD) software, considering the domestic and international regulation of CAD software, according to current Medical Device Classification Catalog and related laws of China Food and Drug Administration (CFDA), this paper investigated and analyzed the classification of CAD software, and provided technical suggestion on classifying principle of CAD software applying Artificial Intelligence (AI) or other advanced technology from medical device regulation scope, for the reference of regulatory and technical departments.

[Research of Establishing of Standard Radiation Qualities and Radiation Conditions for Use in the Determination and Characteristics of Medical Diagnostic X-ray Equipment].

The standard of YY/T 0481-2004 Medical diagnostic X-ray equipment-Radiation conditions for use in the determination and characteristics has been revised and replaced in 2012. This paper first introduces the key technical problems to be solved in establishing standard radiation quality and radiation conditions by comparing the main changes of the two versions standards, including the expression of radiation quality and radiation conditions, the measurement of X-ray tube voltage, and the measuring of the practical peak voltage. Then it introduces a procedure for establishing standard radiation quality and radiation conditions.

[Research on the Standardization System of Diagnosis Products at Home and Abroad].

Objective: The quality of diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.

Methods: Through a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.

Combined therapy with osimertinib and afatinib in a lung adenocarcinoma patient with EGFR T790M mutation and multiple HER2 alterations after resistance to icotinib: A case report.

Acquired resistance inevitably occurs after initial treatment with first-generation EGFR-tyrosine kinase inhibitors (TKIs). Several mechanisms have been identified, including EGFR T790M mutation and HER2 amplification. Herein, we present the case of a patient who progressed on first-generation EGFR-TKIs and developed EGFR T790M mutation, HER2 amplification, and HER2 mutation.

[Study on Informatization of Medical Device Administration in China].

To analyze the current situation about informatization construction of medical device administration in China, including such links of market access of medical device, occupation access of enterprise, risk monitoring of postmarketing, sampling and testing of post-marketing, complaint and inspecting, advertising management and standard management. By the informatization of medical device administration, some supervision problems can be solved, supervision efficiency can be promoted. For accelerating the informatization construction of medical device administration, we should do top-level design and implement by step, pay more attention to the informatization of manufacturing enterprise, product tracing and standard management, in order to continually improve the level of medical device administration.

[Research on Standard System of Home Use Electronic Medical Devices].

Medical device going home is an inevitable trend, however, using these devices has potential safety risks. Through introducing the home use electronic medical device products and related medical device standards, this paper provides recommendations on construction of standard system for home use electronic medical devices, to improve the advancement of existing medical device standard system and guide future medical standardization work, to fully utilize standars's guiding and security role in the scientific and technological innovation, industrial development.

Antialgal compounds with antialgal activity against the common red tide microalgae from a green algae Ulva pertusa.

Nine antialgal active compounds, (i.e. trehalose (1), twenty-two methyl carbonate (2), (-)-dihydromenisdaurilide (3), 3,7,11,15-tetramethyl-2-hexadecen-1-ol (4), isophytol (5), 8-hexadecenol (6), 17-hydroxyheptadecanoic acid (7), trans-asarone (8) and 2-amino-3-mercaptopropanoic acid (9)) were isolated from Ulva pertusa for the first time by sephadex LH-20 column chromatography, silica gel column chromatography and repeated preparative TLC.

[Research on Endothelial Cytocompatibility of Magnesium Alloy].

In-stent restenosis is a main problem in the application of stents. It has been proved that rapid endothelialization of stents after implantation is the key point for solving the problem of restenosis. Recent years researchers focus on developing biodegradable magnesium alloy stents.

Isolation, purification, and identification of antialgal substances in green alga Ulva prolifera for antialgal activity against the common harmful red tide microalgae.

Ten compounds (1~10) were successfully isolated from green algae Ulva prolifera through the combination of silica gel column chromatography, Sephadex LH-20 column chromatography and repeated preparative thin-layer chromatography. These ten compounds showed antialgal activity against red tide microalgae. Among them, compounds 3, 6, and 7 showed stronger antialgal activity against red tide microalgae.

The isolation and antioxidant activity of polysaccharides from the marine microalgae Isochrysis galbana.

Three polysaccharides, IPSI-A, IPSI-B and IPSII, were successfully isolated from the marine microalgae Isochrysis galbana through a combination of anion-exchange column chromatography and repeated gel chromatography. These three polysaccharides were demonstrated to have moderate scavenging activities against superoxide and hydroxyl radicals and moderate reductive power in a concentration-dependent manner. The IPSII demonstrated more effective antioxidant activities than IPSI-A and IPSI-B.

[The investigation of nickel dissolution from nitinol under different extraction conditions in biological tests].

The dissolution of nickel from nitinol alloy under different extraction conditions was investigated when biological tests of nitinol medical devices were carried out. It discussed the equivalence of these extraction conditions and found the best extraction conditions. In the experiment, two brands of nitinol were chosen and extracted under different extraction conditions according to GB/T 16886-12.