A Survey on an Emerging Safety Challenge for Autonomous Vehicles:Safety of the Intended Functionality

As the complexity of autonomous vehicles(AVs)continues to increase and artificial intelligence algorithms are becoming increasingly ubiquitous,a novel safety concern known as the safety of the intended functionality(SOTIF)has emerged,presenting significant challenges to the widespread deployment of AVs.SOTIF focuses on issues arising from the functional insufficiencies of the AVs’intended functionality or its implementation,apart from conventional safety considerations.From the systems engineering standpoint,this study offers a comprehensive exploration of the SOTIF landscape by reviewing academic research,practical activities,challenges,and perspectives across the development,verification,validation,and operation phases.Academic research encompasses system-level SOTIF studies and algorithm-related SOTIF issues and solutions.Moreover,it encapsulates practical SOTIF activities undertaken by corporations,government entities,and academic institutions spanning international and Chinese contexts,focusing on the overarching methodologies and practices in different phases.Finally,the paper presents future challenges and outlook pertaining to the development,verification,validation,and operation phases,motivating stakeholders to address the remaining obstacles and challenges.

Safety Performance Functions for Traffic Signals:Phasing and Geometry

A significant proportion of urban crashes,especially serious and fatal crashes,occur at traffic signals.Many of the black-spots in both Australia and New Zealand cities occur at high volume and/or high-speed traffic signals.Given this,crash reduction studies often focus on the major signalised intersections.However,there is limited information that links the phasing configuration,degree of saturation and overall cycle time to crashes.While a number of analysis tools are available for assessing the efficiency of intersections,there are very few tools that can assist engineers in assessing the safety effects of intersection upgrades and new intersections.Safety performance functions have been developed to help quantify the safety impact of various traffic signal phasing configurations and level of intersection congestion at low and high-speed traffic signals in New Zealand and Australia.Data from 238 signalised intersection sites in Auckland,Wellington,Christchurch,Hamilton,Dunedin and Melbourne was used to develop crash prediction models for key crash-causing movements at traffic signals.Different variables(road features)effect each crash type.The models indicate that the safety of intersections can be improved by longer cycle times and longer lost inter-green times,especially all-red time,using fully protected right turns and by extending the length of right turn bays.The exception is at intersections with lots of pedestrians where shorter cycle times are preferred as pedestrian crashes increase with longer wait times.A number of factors have a negative impact on safety including,free left turns,more approach lanes,intersection arms operating near or over capacity in peak periods and higher speed limits.

IEC/TC1082024年春季工作组会议综述

介绍IEC/TC108 HBSDT工作组2024年春季虚拟会议情况,包括对IEC 62368-1:2023的新技术提案讨论、特别小组讨论、解释组文件讨论及相关决议讨论等。

基于扎根理论及G1-CRITIC-距离函数判法-VIKOR的铁路建设项目安全管理标准化评价

为促进安全管理标准化管理模式顺利实施,铁路建设项目安全管理迈向高标准高水平,开展铁路建设项目安全管理标准化评价研究。首先,以标准化管理为理论基础,根据质性研究方法-扎根理论对数据进行编码处理,建立以制度管理标准化、人员配备标准化、物料管理标准化、环境管理标准化、现场作业标准化、过程控制标准化为6个核心范畴和32个主范畴的铁路建设项目安全管理标准化评价指标体系。其次,借助劳伦茨曲线的基尼系数改进CRITIC方法,提出“G1-CRITIC-距离函数判别法”模型,计算属性权重。最后,采用VIKOR算法对案例项目进行实证分析,基于安全管理标准化值U_(R)评估标准化管理水平。结果表明:各案例项目的安全管理标准化水平不同,U_(R)值具有显著差异,P_(1)~P_(5)各项目的U_R值分别为0.047 6、0.148 3、0.451 9、0.971 5、0.648(其中P_(4)属于“高水平”;P_(3)和P_(5)属于“中水平”;P_(1)和P_(2)属于“低水平”)。通过折衷系数扰动下的敏感性分析,综合考虑群体效用和个体妥协,对不同等级的建设项目(P_(1)~P_(5))分别进行讨论,并提出标准化建设的决策建议。研究结果与各案例项目实际安全管理标准化程度相符,为深入推进铁路建设项目标准化管理工作、促进建设项目各项安全管理行为规范运作和管理体系的持续改进提供参考依据。

Functionalized Hydrogel-Based Wearable Gas and Humidity Sensors

Breathing is an inherent human activity;however,the composition of the air we inhale and gas exhale remains unknown to us.To address this,wearable vapor sensors can help people monitor air composition in real time to avoid underlying risks,and for the early detection and treatment of diseases for home healthcare.Hydrogels with three-dimensional polymer networks and large amounts of water molecules are naturally flexible and stretchable.Functionalized hydrogels are intrinsically conductive,self-healing,self-adhesive,biocompatible,and room-temperature sensitive.Compared with traditional rigid vapor sensors,hydrogel-based gas and humidity sensors can directly fit human skin or clothing,and are more suitable for real-time monitoring of personal health and safety.In this review,current studies on hydrogel-based vapor sensors are investigated.The required properties and optimization methods of wearable hydrogel-based sensors are introduced.Subsequently,existing reports on the response mechanisms of hydrogel-based gas and humidity sensors are summarized.Related works on hydrogel-based vapor sensors for their application in personal health and safety monitoring are presented.Moreover,the potential of hydrogels in the field of vapor sensing is elucidated.Finally,the current research status,challenges,and future trends of hydrogel gas/humidity sensing are discussed.

Efficacy of prednisone combined with mycophenolate mofetil for immunoglobulin A nephropathy with moderate-to-severe renal dysfunction

BACKGROUND Immunoglobulin A nephropathy(IgAN)is a common form of chronic glomer-ulonephritis.Currently,IgAN is one of the main causes of chronic renal failure in China;its prognosis varies greatly between patients,with renal function at the time of diagnosis and prognosis being strongly correlated.Mycophenolate mofetil(MMF)is a drug with a good immunomodulatory effect and is commonly used clinically.However,its effects in IgAN have not yet been clearly demonstrated.Therefore,herein,we retrospectively compared the effectiveness and safety of prednisone alone or combined with MMF for the treatment of primary IgAN with moderate-to-severe renal impairment.METHODS Between January 2011 and December 2020,200 patients with moderate-to-severe IgAN were included in this study,all of whom were admitted to Wuxi People's Hospital affiliated with Nanjing Medical University.All patients underwent a renal puncture biopsy,which revealed primary IgAN with a glomerular filtration rate(GFR)of 30–60 mL/min.The patients were divided into a glucocorticoid therapy group(GTG)and an immunosuppressive therapy group(ITG)according to the different treatment regimens,with 100 patients in each group.Based on general treatments,such as angiotensin-converting enzyme inhibitors/angiotensin receptor blockers,patients in the GTG were administered prednisone 0.5–0.8 mg/(kg·d^(-1))for 4–8 wk,which was reduced by 5 mg every two weeks until the maintenance(30 mg/d)dose was reached and maintained for 12 mo.In the ITG,MMF was administered at 1.0 g/d for 6–12 mo,followed by a maintenance dosage of 0.5 g/d for 12 mo.Age,sex,blood pressure,24-h urinary egg white measurement,serum creatinine(Scr),blood uric acid,blood albumin,blood potassium(K),hemoglobin,GFR,alanine aminotransferase,total cholesterol(T-CHO),fasting blood glucose,and body mass index were recorded.The 24-h urinary protein,Scr,and GFR levels were recorded 3,6,9,and 12 mo after treatment.Follow-up data were also collected.RESULTS No discernible differences existed between the two groups in terms of age,sex,blood pressure,creatinine,24-h urinary protein level,GFR,or other biochemical indicators at the time of enrollment.Both regimens significantly reduced the 24-h urinary protein quantitation and stabilized renal function.Nine months after treatment,the 24-h urinary protein and Scr of the ITG decreased more significantly than those of the GTG.By the 12th month of treatment,the 24-h urinary protein and Scr in both groups continued to decrease compared to those by the 9th month.In addition,the overall response rate in the ITG was significantly higher than that in the GTG.The occurrence of side effects did not vary significantly between the two regimens;however,endpoint events were significantly more common in the GTG than in the ITG.The follow-up time for the GTG was noticeably lower than that for the ITG.CONCLUSION Prednisone combined with MMF was effective for the treatment of IgAN with moderate-to-severe renal dysfunction.

Indirect comparison of efficacy and safety of chiglitazar and thiazolidinedione in patients with type 2 diabetes:A meta-analysis

BACKGROUND Chiglitazar is an emerging pan-agonist of all peroxisome proliferator activated receptors(PPAR)-α,δandγ,and has therapeutic potential for type 2 diabetes(T2D).However,to date,no clinical studies or meta-analyses have compared the efficacy and safety of chiglitazar and traditional PPAR-γagonist thiazolidinediones(TZDs).A meta-analysis concerning this topic is therefore required.AIM To compare the efficacy and safety of chiglitazar and TZD in patients with T2D.METHODS PubMed,Medline,Embase,the Cochrane Central Register of Controlled Trials,Reference Citation Analysis and Clinicaltrial.gov websites were searched from August 1994 to March 2022.Randomized controlled trials(RCTs)of chiglitazar or TZD vs placebo in patients with T2D were included.Indirect comparisons and sensitivity analyses were implemented to evaluate multiple efficacy and safety endpoints of interest.RESULTS We included 93 RCTs that compared TZD with placebo and one that compared chiglitazar with placebo.For efficacy endpoints,the augmented dose of chiglitazar resulted in greater reductions in hemoglobin(Hb)A1c[weighted mean difference(WMD)=-0.15%,95%confidence interval(CI):-0.27 to-0.04%],triglycerides(WMD=-0.17 mmol/L,95%CI:-0.24 to-0.11 mmol/L)and alanine aminotransferase(WMD=-5.25 U/L,95%CI:-8.50 to-1.99 U/L),and a greater increase in homeostasis model assessment-β(HOMA-β)(WMD=17.75,95%CI:10.73-24.77)when compared with TZD treatment.For safety endpoints,the risks of hypoglycemia,edema,bone fractures,upper respiratory tract infection,urinary tract infection,and weight gain were all comparable between the augmented dose of chiglitazar and TZD.In patients with baseline HbA1c≥8.5%,body mass index≥30 kg/m^(2)or diabetes duration<10 years,the HbA1c reduction and HOMA-βincrease were more conspicuous for the augmented dose of chiglitazar compared with TZD.CONCLUSION Augmented dose of chiglitazar,a pan-activator of PPARs,may serve as an antidiabetic agent with preferable glycemic and lipid control,betterβ-cell function preserving capacity,and does not increase the risk of safety concerns when compared with TZD.

Constrained Moving Path Following Control for UAV With Robust Control Barrier Function

This paper studies the moving path following(MPF)problem for fixed-wing unmanned aerial vehicle(UAV)under output constraints and wind disturbances.The vehicle is required to converge to a reference path moving with respect to the inertial frame,while the path following error is not expected to violate the predefined boundaries.Differently from existing moving path following guidance laws,the proposed method removes complex geometric transformation by formulating the moving path following problem into a second-order time-varying control problem.A nominal moving path following guidance law is designed with disturbances and their derivatives estimated by high-order disturbance observers.To guarantee that the path following error will not exceed the prescribed bounds,a robust control barrier function is developed and incorporated into controller design with quadratic program based framework.The proposed method does not require the initial position of the UAV to be within predefined boundaries.And the safety margin concept makes error-constraint be respected even if in a noisy environment.The proposed guidance law is validated through numerical simulations of shipboard landing and hardware-in-theloop(HIL)experiments.

Introducing the nth-Order Features Adjoint Sensitivity Analysis Methodology for Nonlinear Systems (nth-FASAM-N): II. Illustrative Example

This work highlights the unparalleled efficiency of the “nth-Order Function/ Feature Adjoint Sensitivity Analysis Methodology for Nonlinear Systems” (nth-FASAM-N) by considering the well-known Nordheim-Fuchs reactor dynamics/safety model. This model describes a short-time self-limiting power excursion in a nuclear reactor system having a negative temperature coefficient in which a large amount of reactivity is suddenly inserted, either intentionally or by accident. This nonlinear paradigm model is sufficiently complex to model realistically self-limiting power excursions for short times yet admits closed-form exact expressions for the time-dependent neutron flux, temperature distribution and energy released during the transient power burst. The nth-FASAM-N methodology is compared to the extant “nth-Order Comprehensive Adjoint Sensitivity Analysis Methodology for Nonlinear Systems” (nth-CASAM-N) showing that: (i) the 1st-FASAM-N and the 1st-CASAM-N methodologies are equally efficient for computing the first-order sensitivities;each methodology requires a single large-scale computation for solving the “First-Level Adjoint Sensitivity System” (1st-LASS);(ii) the 2nd-FASAM-N methodology is considerably more efficient than the 2nd-CASAM-N methodology for computing the second-order sensitivities since the number of feature-functions is much smaller than the number of primary parameters;specifically for the Nordheim-Fuchs model, the 2nd-FASAM-N methodology requires 2 large-scale computations to obtain all of the exact expressions of the 28 distinct second-order response sensitivities with respect to the model parameters while the 2nd-CASAM-N methodology requires 7 large-scale computations for obtaining these 28 second-order sensitivities;(iii) the 3rd-FASAM-N methodology is even more efficient than the 3rd-CASAM-N methodology: only 2 large-scale computations are needed to obtain the exact expressions of the 84 distinct third-order response sensitivities with respect to the Nordheim-Fuchs model’s parameters when applying the 3rd-FASAM-N methodology, while the application of the 3rd-CASAM-N methodology requires at least 22 large-scale computations for computing the same 84 distinct third-order sensitivities. Together, the nth-FASAM-N and the nth-CASAM-N methodologies are the most practical methodologies for computing response sensitivities of any order comprehensively and accurately, overcoming the curse of dimensionality in sensitivity analysis.

IEC 62282-3-400:2016《燃料电池技术-第3-400部分:固定式燃料电池动力系统-带热电联合输出的小型固定式燃料电池动力系统》标准解析

燃料电池热电联产系统作为分布式供能的重要技术路径,目前已实现产业化应用,燃料电池热电联产系统的相关标准体系逐步完善。本文针对国际电工委员会发布的IEC62282-3-400:2016《燃料电池技术–第3-400部分:固定式燃料电池动力系统–带热电联合输出的小型固定式燃料电池动力系统》标准进行解读。重点阐述了标准的使用范围及主要内容和技术要求包括设备分类、安全要求和防护措施、功能特性、标记安装和操作说明等,旨在为燃料电池热电联产相关行业提供技术参考。

不同剂量新活素在急诊PCI治疗急性心肌梗死中的效果与安全性

目的分析不同剂量新活素在急诊经皮冠状动脉介入(PCI)治疗急性心肌梗死中的效果与安全性。方法64例急性心肌梗死患者随机分为两组。在急诊PCI治疗期间,A组给予0.01μg·kg^(-1)·min^(-1)新活素,B组给予0.015μg·kg^(-1)·min^(-1)新活素,持续给药24 h。比较两组的治疗效果、血管内皮功能以及不良反应。结果两组的治疗总有效率、不良反应发生率比较,差异无统计学意义(P>0.05)。治疗后,B组的ET-1明显低于A组,NO明显高于A组(P<0.05)。结论大剂量新活素可明显改善急诊PCI治疗的急性心肌梗死患者的临床症状,提升其血管内皮功能,且不会增加用药风险。

基于AURIX TC397 SafeTpack的功能安全软件实现

动力域控制器系统(PDCS)在新能源汽车中为动力源控制器系统。为提高PDCS的安全性、可靠性,根据ISO 26262标准设计了一套符合ISO 26262标准ASIL C的域控制器平台,基于E-GAS三层安全架构,其中重点解决Level3层的安全监控,以功能安全组件包SafeTpack为基础,结合AutoSAR组件实现程序流监控,基于英飞凌AURIX TC397处理器、电源管理芯片TLF35584及CAN收发器TJA1145等器件验证了系统的正确性。结果显示:本系统功能安全框架及level3层的安全监控有效保障了系统出现故障时能够被及时复位断开TJA1145供电实现关闭通信,达到安全状态。

Introduction to Wireless Endogenous Security and Safety:Problems, Attributes, Structures and Functions

The information security and functional safety are fundamental issues of wireless communications sytems.The endogenous security principle based on Dynamic Heterogeneous Redundancy provides a direction for the development of wireless communication security and safety technology.This paper introduces the concept of wireless endogenous security from the following four aspects.First,we sorts out the endogenous security problems faced by the current wireless communications system,and then analyzes the endogenous security and safety attributes of the wireless channel.After that,the endogenous security and safety structure of the wireless communications system is given,and finally the applications of the existing wireless communication endogenous security and safety functions are listed.

Exponential-Alpha Safety Criteria of a Class of Dynamic Systems With Barrier Functions

A classic kind of researches about the operational safety criterion for dynamic systems with barrier function can be roughly summarized as functional relationship,denoted by⊕,between the barrier function and its first derivative for time t,where⊕can be“=”,“<”,or“>”,etc.This article draws on the form of the stable condition expression for finite time stability to formulate a novel kind of relaxed safety judgement criteria called exponential-alpha safety criteria.Moreover,we initially explore to use the control barrier function under exponential-alpha safety criteria to achieve the control for the dynamic system operational safety.In addition,derived from the actual process systems,we propose multi-hypersphere methods which are used to construct barrier functions and improved them for three types of special spatial relationships between the safe state set and the unsafe state set,where both of them can be spatially divided into multiple subsets.And the effectiveness of the proposed safety criteria are demonstrated by simulation examples.

Safety and Quality of Care Evaluation in Japanese Long-Term Facilities Focused on the Activity Condition and Cognitive Function of Residents

Objective: Currently, standards for evaluating long-term care facilities do not exist in Japan. This study aimed to evaluate the quality of healthcare services in Japan’s long-term care facilities and identify the structural and process indicators associated with the facilities’ outcome indicators. Methods: This retrospective study assessed changes in residents’ abilities to participate in physical activities, their cognitive function, and their vulnerability to injuries. From 2012 to 2013, we collected information on the healthcare services at 1067 long-term care facilities registered with Japan’s Welfare, Health and Medical Care Information Network in the Welfare and Medical Service Agency. We examined 12 structural indicators, 26 process indicators, and 7 outcome indicators. We used multivariate linear regression models adjusted to analyze relationships between outcome indicators and structural or process indicators. Results: Residents’ activity and cognitive function indicators either improved by 80% - 90% or were maintained for one year. The Geriatric Functional Independence Measures, the Barthel Index, and holding conferences related to care were all considered activities of daily living. Three adverse events—tumbles and falls, behavioral problems, and aimless wandering or leaving the facility without permission—were factors that restricted residents’ behavior and number of residents per care staff member. Conclusions: Maintaining or improving levels of independence and cognition in daily living requires a care process system that enables ongoing monitoring of residents’ activities of daily living and cognitive functioning. Ensuring the safety of residents and improving the quality of care in long-term care facilities without securing adequate care staff are not possible.

Road Safety Performance Function Analysis With Visual Feature Importance of Deep Neural Nets

Road safety performance function(SPF) analysis using data-driven and nonparametric methods, especially recent developed deep learning approaches, has gained increasing achievements. However, due to the learning mechanisms are hidden in a"black box" in deep learning, traffic features extraction and intelligent importance analysis are still unsolved and hard to generate.This paper focuses on this problem using a deciphered version of deep neural networks(DNN), one of the most popular deep learning models. This approach builds on visualization, feature importance and sensitivity analysis, can evaluate the contributions of input variables on model's "black box" feature learning process and output decision. Firstly, a visual feature importance(Vi FI) method that describes the importance of input features is proposed by adopting diagram and numerical-analysis. Secondly,by observing the change of weights using Vi FI on unsupervised training and fine-tuning of DNN, the final contributions of input features are calculated according to importance equations for both steps that we proposed. Sequentially, a case study based on a road SPF analysis is demonstrated, using data collected from a major Canadian highway, Highway 401. The proposed method allows effective deciphering of the model's inner workings and allows the significant features to be identified and the bad features to be eliminated. Finally, the revised dataset is used in crash modeling and vehicle collision prediction, and the testing result verifies that the deciphered and revised model achieves state-of-theart performance.

Functional Safety for Automotive Ethernet Networks

In this paper,the need for functional safety in automotive Ethernet is investigated.For this the ISO26262 standard is used but also a comparison with legacy IVN(in-vehicle-networking)is made.In addition,an outlook of future automotive networks is considered and investigated if this brings a further need for safety in automotive Ethernet.From these efforts,it was found that there are several drivers for safety in automotive Ethernet that especially hold for switches.

A Novel Approach for Evaluation of Food Functions and Safety Applied in RR GM Soybeans

[Objective] This study aimed to evaluate tbe healthy risk of genetically modified （ GM ） soybeans by using a novel approach for functions and safety of food. [ Me^od] Different from traditional evaluation of substantial equivalence, three great innovations were performed in this study, involving in basic diet, evalu- ation approaches and principle, as well as the clarification of connotation differences between absolute and relative mass of organs. Hence a novel BDI-GS （Bendib Damage Index and General Score） evaluation approach was established and applied in comparative evaluation between RR GM and natural soybeans. Healthy male ICR mice during linear growth were selected; experimental mice were fed with 15% RR GM soybeans and 15% natural soybeans blending maize meal diets, and control mice were fed with single maize meal diet for 13 d; the mice were dissected after collecting blood samples and perfectly obtained nine organs or tissues to re- cord their masses and conduct statistical analyses. [Result] Plenty of matching information was obtained through simple design. The growth performance of treated mice was markedly of individual differences, some mice were thwarted due to regular intake of RR soybeans. Meanwhile, the functions and safety of RR soybeans were markedly lowered in overall nutritional and healthy effects than those of natural soybeans expressed in GS values, and presents some declines in nutrition and health of thymus, pancreas and spermary; especially, it can make thymus immune （P 〈0.05） in markedly lower level than that of natural soybeans. [ Conclusion] Therefore, major troubles and risks of RR soybeans intake are of personal risks in different degrees, in addition, it may increase sub-health and related chronic epi- demics risks, and herein it will presents certain safety issues. The creation of this novel evaluation system provides a simple and available evaluation approach for functions and potential risks revelation of food effects, and will yield far-reaching influences to safety evaluation and healthy development of GM foods, as well as public health.

Critical review and functional safety of a battery management system for large‑scale lithium‑ion battery pack technologies

The battery management system(BMS)is the main safeguard of a battery system for electric propulsion and machine electrifcation.It is tasked to ensure reliable and safe operation of battery cells connected to provide high currents at high voltage levels.In addition to efectively monitoring all the electrical parameters of a battery pack system,such as the voltage,current,and temperature,the BMS is also used to improve the battery performance with proper safety measures within the system.With growing acceptance of lithium-ion batteries,major industry sectors such as the automotive,renewable energy,manufacturing,construction,and even some in the mining industry have brought forward the mass transition from fossil fuel dependency to electric powered machinery and redefned the world of energy storage.Hence,the functional safety considerations,which are those relating to automatic protection,in battery management for battery pack technologies are particularly important to ensure that the overall electrical system,regardless of whether it is for electric transportation or stationary energy storage,is in accordance with high standards of safety,reliability,and quality.If the system or product fails to meet functional and other safety requirements on account of faulty design or a sequence of failure events,then the environment,people,and property could be endangered.This paper analyzed the details of BMS for electric transportation and large-scale energy storage systems,particularly in areas concerned with hazardous environment.The analysis covers the aspect of functional safety that applies to BMS and is in accordance with the relevant industrial standards.A comprehensive evaluation of the components,architecture,risk reduction techniques,and failure mode analysis applicable to BMS operation was also presented.The article further provided recommendations on safety design and performance optimization in relation to the overall BMS integration.

Functional safety verification and performance measurement of train-train communication link

The short-range wireless communication technology has advanced considerably and provides the feasibility of train-train(T2T)communication link in the communication-based train control system.The introduction of the T2T link would reduce the headway and improve operational efficiency.Formal methods are system design techniques that use rigorously specified mathematical models to ensure all behaviors work as expected.And it is exactly the functional safety verification needed.Therefore,to deal with the functional safety verification of the T2T link,an untimed colored petri net model is first constructed.Secondly,the verification process is performed.Conclusions can be drawn from the state space report and the computation tree logic queries.Lastly,the model is parameterized,and then data log files are obtained for further performance measurement.Results show that the proposed criteria are satisfied and there are no defects in the basic design requirements.The transmission delay has considered the reconnection,transmission errors and the interruption.The probability of the delay lower than 150 ms accounts for 98.106%,which meets the specification and the previous field test.