Objective Comprehensive standards of active implantable medical devices with high risks are required by China's current industrial development, and standard problems and ideas are discussed in this paper.Methods Analysis of the status of China's active implantable medical device standards and international standards. For the booming field for active implantable medical devices with high risks, international standard’s problems, ideas and trends are analyzed. Results Bottleneck of the development of China's active implantable medical device standards is the lack of Chinese medical devices industry actual independent research and development capability. China's independent standard research on the basis of independent core technology of active implantable medical devices is the opportunity to promote the internationalization of China standard.Conclusion Improving the standards of active implantable medical devices based on independent core technology, combined with problems of existing international standards, to further improve and develop international standards and lead high level international technical standards.

Objective:Non-alcoholic fatty liver disease(NAFLD)is a common metabolic disorder in overweight and obese children,and its etiology and pathogenesis remain unclear,lacking effective preventive and therapeutic measures.This study aims to explore the association between whole blood copper,zinc,calcium,magnesium and iron levels and NAFLD in overweight and obese children aged 6 to 17 years,providing a scientific basis for the prevention and intervention of early NAFLD in overweight and obese children. Methods:A cross-sectional study design was used to collect relevant data from overweight and obese children who visited the Hunan Children's Hospital from January 2019 to December 2021 through questionnaire surveys.Fasting blood samples were collected from the subjects,and various indicators such as blood glucose,blood lipid,and mineral elements were detected.All children were divided into an overweight group(n=400)and a NAFLD group(n=202).The NAFLD group was divided into 2 subgroups according to the ALT level:A non-alcoholic fatty liver(NAFL)group and a non-alcoholic steatohepatitis(NASH)group.Logistic regression analysis was used to analyze the association between minerals(copper,zinc,calcium,magnesium,and iron)and NAFLD,NAFL and NASH. Results:A total of 602 subjects were included,of whom 73.6%were male,with a median age of 10(9,11)years,and a body mass index(BMI)of 24.9(22.7,27.4)kg/m2.The intergroup comparison results showed that compared with the overweight group,the NAFLD group had higher levels of age,BMI,diastolic blood pressure(DBP),systolic blood pressure(SBP),triglyceride(TG),low density lipoprotein(LDL),alanine transaminase(ALT)and aspartate aminotransferase(AST),and lower level of high density lipoprotein(HDL).The NAFL group had higher levels of age,BMI,DBP,SBP,ALT,and AST,and lower levels of HDL compared with the overweight group.The levels of age,BMI,DBP,SBP,TG,LDL,ALT,and AST of NASH were higher than those in the overweight group,while the level of HDL was lower than that in overweight group(all P<0.017).After adjusting for a variety of confounders,the OR of NAFLD for the highest quantile of iron was 1.79(95%CI 1.07 to 3.00)compared to the lowest quantile,and no significant association was observed between copper,zinc,calcium,and magnesium,and NAFLD.The subgroup analysis of NAFLD showed that the OR for the highest quantile of iron in children with NAFL was 2.21(95%CI 1.26 to 3.88),while no significant association was observed between iron level and NASH.In addition,no significant associations were observed between copper,zinc,calcium,and magnesium levels and NAFL or NASH. Conclusion:High iron level increases the risk of NAFLD(more likely NAFL)in overweight and obese children,while copper,zinc,calcium,magnesium,and other elements are not associated with the risk of NAFLD in overweight and obese children.

Objective: To explore the relationship between cerebral hemorrhagic transformation (HT) and angiographic early venous filling (EVF) following mechanical thrombectomy for acute ischemic stroke. Methods: A retrospective imaging analysis was performed in the consecutive patients treated from January 2015 to November 2018 for acute anterior circulation large vessel occlusion using mechanical thrombectomy on the Affiliated Hospital of Yangzhou University. The demography, vascular risk factors and other clinical data of the patients were also collected. According to the experimental study of European Cooperative Acute Stroke Study Ⅱ (ECASS Ⅱ), the modified classification of HT after mechanical thrombectomy was divided into HT negative, HT-Ⅰ type and HT-Ⅱ type. The differences in EVF, clinical and demographic characteristics were compared. Multivariate logistic regression analysis was used to identify the independent risk factors for HT and clinical outcome. Diagnostic test characteristics of EVF for HT-Ⅱ type were determined using a receiver operating characteristic curve (ROC) analysis. Results: A total of 98 patients with acute ischemic stroke who received mechanical thrombectomy were enrolled, including HT negative in 48 cases (49.0%, 48/98), HT-Ⅰ in 40 cases (40.8%, 40/98) and HT-Ⅱ in 10 cases (10.2%, 10/98). Significant differences were noted in age, and incidence of atrial fibrillation, EVF and poor outcomes among three groups (P<0.05). Multivariate logistic regression analysis showed that EVF [odds ratio (OR) 5.960, 95%CI 1.750-8.960, P=0.001] and atrial fibrillation (OR 3.485, 95%CI 1.962-18.986, P=0.028) were risk factors for the occurrence of HT-Ⅱ after mechanical thrombectomy. No risk factor for HT-Ⅰ was noted. Baseline National Institute of Health Stroke Scale (NIHSS) score (OR 1.162, 95%CI 1.021-1.345, P=0.038), EVF (OR 5.358, 95%CI 1.665-13.653, P=0.006) and HT-Ⅱ (OR 1.326, 95%CI 1.226-2.038, P=0.032) were independent risk factors for poor outcomes. And the sensitivity and specificity of EVF in prediction for HT-Ⅱ were 80.0% and 86.4% respectively, with the area under the ROC curve of 0.832. Conclusion Presence of EVF after mechanical thrombectomy may be the predictor for HT-Ⅱ, which indicates the poor clinical outcomes for acute ischemic stroke patients.