• Title/Summary/Keyword: Safety requirements

Search Result 1,708, Processing Time 0.035 seconds

Certification and Use of Reference Materials (표준물질의 인증 및 사용)

  • Choi, Sung-Woon
    • Proceedings of the Safety Management and Science Conference
    • /
    • 2007.04a
    • /
    • pp.323-333
    • /
    • 2007
  • This paper presents contents of certificates, and use for reference materials. This study also introduces general requirements for the competence of reference material producers. Lastly this paper shows general and statistical principles for certification of reference materials.

  • PDF

A Study on the Effect of Safety culture on safety in railway industry (철도산업에서 Safety culture 가 Safety에 미치는 영향에 관한 연구)

  • Heo, Eun-Mee;Kim, Sa-Kil;Byun, Seong-Nam
    • Proceedings of the KSR Conference
    • /
    • 2007.11a
    • /
    • pp.1783-1786
    • /
    • 2007
  • The purpose of this study is to analyze human safety culture of the railway driver in domestic railway industry. This study proposes safety culture improvement of domestic railway by intensively comparing railway safety system overseas to reinforce domestic railway safety. Domestic railways well known the well-organized railway safety culture has brought up safety issues on their process of private management. With this process, also, domestic safety culture is requested by increasing sense of the safety for general public. This study expects Korean railways to become a well-organized that as removing insecure factors of domestic railway based on result comparing and analyzing the manual, factors and requirements of guideline for internal and external safety culture.

  • PDF

TSO Authorization of Airborne Multipurpose Electronic Displays (항공기용 다목적 디스플레이의 기술표준품 인증)

  • Cheon, Young-Ho;Lee, Seoung-Pil;Park, Jun-Hyeon
    • Journal of Advanced Navigation Technology
    • /
    • v.17 no.6
    • /
    • pp.765-776
    • /
    • 2013
  • Civilian aircraft industry, even if the superior performance of the product in order to ensure the safety of aircraft navigation safety requirements necessary for compliance does not receive a legally recognized can not be used in aircraft characteristics. These are applied in a variety of safety in avionics for navigation of civil aircraft certification standards for the technology is implemented. KTSO-C113 aircraft for the purpose of electronic display technology to authenticate standard contains minimum performance standards. Standard design and manufacturing technology for type approval means approval by mounting the aircraft in order to use a separate approval is required. Through this paper, multi-display technology standards for aircraft type certification approval system and demonstrate compliance with the requirements for the certification practices introduced are presented.

ISO14971:2019 Detailed Analysis and Periodic Safety Update Report Establishment Method for the Single Use Medical Device - Focusing on Medical Device Regulation 2017/745 requirements (일회용 의료기기에 적용을 위한 ISO 14971:2019 분석과 Periodic Safety Update Report 작성 방법 - Medical Device Regulation 2017/745 요구사항 중심으로)

  • Sang Min, Park;Gyu Ha, Ryu
    • Journal of Biomedical Engineering Research
    • /
    • v.44 no.1
    • /
    • pp.1-10
    • /
    • 2023
  • With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

A Study on Safety Coordination for a Complex System Comprised of Interoperable Systems Utilizing DoD Architectural Framework (상호운용성을 요구하는 복합시스템 개발에서 DoD 아키텍처 프레임워크를 활용한 안전성 확보에 관한 연구)

  • Kim, Young-Min;Lee, Jae-Chon
    • Journal of the Korea Safety Management & Science
    • /
    • v.15 no.1
    • /
    • pp.1-10
    • /
    • 2013
  • The recent trend in the war fields on the globe may be characterized by the network-centric warfare, which would, in turn, make the concept of weapon systems be changed. To this end, the concept of system of systems (SoS) has been introduced in literature. An SoS is a collection of multiple systems, each of which is an independent system and can be interoperable with each other. Thus, in defense domain each SoS is a big weapon system as a whole operated in actual environment and each element of it is also an independent smaller weapon system, but they should be interoperable via network among each other. The safety results studied for each elementary system alone may not be fully applicable to the whole SoS. As such, the objective of this paper is to study how to make the SoS safety requirements be distributed down over the interoperable elementary systems. Since handling the interoperability requires a technique of systems architecture, a standard method called the DoD Architectural Framework (DoDAF) has been used here to derive a solution. Using DoDAF, the safety requirements were first analyzed in the operability environment. The results were then studied to be included in an integrated model of both the systems design and safety processes. A further study of present paper would facilitate ensuring safety in the development of SoS weapon systems in practice.

The Change of Safety Management and the Safety Counter-plan (안전관리와 예비대책 변화 방향)

  • 서지한;서광규;고용해
    • Proceedings of the Safety Management and Science Conference
    • /
    • 2002.05a
    • /
    • pp.15-21
    • /
    • 2002
  • In the future, all kinds condition of industrial safety is a primary need in all advanced countries in which workplace safety is an issue. Furthermore, the increasing complexity of production systems and the rapidity of technological innovation have consolidated the recognition of the strategic value of safety, alongside the traditional competitive factors such as quality, costs, delivery time and flexibility, In this paper, the some critical issues of changes and counter-plan in an adequate safety management were identified by above considerations as follows: needs of systematic identification and analysis of safety factors; requirements to define priorities and budgeting to support the decision-making process; and needs of audit activities and indicators which measure company performance in terms of safety improvements, and so on.

  • PDF

Compliant Ultrasound Proximity Sensor for the Safe Operation of Human Friendly Robots Integrated with Tactile Sensing Capability

  • Cho, Il-Joo;Lee, Hyung-Kew;Chang, Sun-Il;Yoon, Euisik
    • Journal of Electrical Engineering and Technology
    • /
    • v.12 no.1
    • /
    • pp.310-316
    • /
    • 2017
  • The robot proximity and tactile sensors can be categorized into two groups: grip sensors and safety sensors. They have different performance requirements. The safety sensor should have long proximity range and fast response in order to secure enough response time before colliding with ambient objects. As for the tactile sensing function, the safety sensor need to be fast and compliant to mitigate the impact from a collision. In order to meet these requirements, we proposed and demonstrated a compliant integrated safety sensor suitable to human-friendly robots. An ultrasonic proximity sensor and a piezoelectric tactile sensor made of PVDF films have been integrated in a compliant PDMS structure. The implemented sensor demonstrated the maximum proximity range of 35 cm. The directional tolerance for 30 cm detection range was about ${\pm}15^{\circ}$ from the normal axis. The integrated PVDF tactile sensor was able to detect various impacts of up to 20 N in a controlled experimental setup.

Development of a DFSS Road-map Associated with the ISO 26262 Product Development Process (ISO 26262 제품개발 프로세스와 연계된 DFSS 로드-맵의 개발)

  • Hong, Sung-Hoon;Kwon, Hyuck Moo;Kim, Dong-Chun;Lee, Min Koo
    • IE interfaces
    • /
    • v.25 no.4
    • /
    • pp.393-404
    • /
    • 2012
  • Increasing safety requirements of automobile are asking companies to find out solutions, based on the ISO 26262 which is a functional safety standard. ISO 26262 is an adaptation of the IEC 61508 for automotive electric/electronic systems. ISO 26262 provides a V model for ECU (Electronic Control Unit) development process to secure safety against vehicle. It well describes the requirements, necessary works and their resulting products for each development phase. However, it is difficult to apply to product development for achieving functional safety in the electric/electronic systems of an automobile because it lacks explanation on the working steps to follow and the methodologies and tools to be used in each step. In this paper, we introduce the outline of the ISO 26262 product development process and present a DFSS (Design For Six Sigma) road-map based on the ISO 26262 product development process as a way to operate efficiently the ISO 26262 product development process. The DFSS road-map consists of five phases: Define, Measure, Analyze, Design, and Verify. The detailed activities, tools, inputs, and work products are given for each phase.

Development on the Selection of Green Construction Materials for Residental Safety (거주자 안전을 고려한 친환경 건축재료 선정 시스템개발)

  • Song, Hyuk;Chung, Woo-Yang
    • Journal of the Korean Society of Safety
    • /
    • v.20 no.4 s.72
    • /
    • pp.63-70
    • /
    • 2005
  • It has been used so many kinds of architectural materials and interior products in current building construction, and use of composite architectural materials is increasing with the development of chemical technology. As the green architecture has become the center of public interest, much effort is conducted in advanced countries on the LCA point of view, such as restriction of architectural materials that emitting pollution substances, developing of Non-Toxic architectural materials, and recycling of used materials, etc. with the cooperation of related organizations, material manufacture companies, and construction companies. Because the kinds of materials to be used in building constructions are so various, there might be some possibility of personal and subjective choice at the time of materials selection resulting the missing the requirements of building components and the choice of harmful materials to human. One way to resolve the material problem is to present the green architectural materials which coincide with the quality performance at service and not harmful to man and nature. At this point of view, this study aims to develop the material classification model by investigating the major labelling system about green architectural materials in both domestic and abroad and to implement an efficient material selection system by making a powerful database of environmental standard and quality basis of building requirements.

A Study on the Elevator Overbalance-Ratio Control and Improved Scheme for Safety (엘리베이터 오버밸런스율 제어와 안전을 위한 개선방안 연구)

  • Lee, Ho-Cheol;Choi, Young-Kiu
    • Journal of the Korea Institute of Information and Communication Engineering
    • /
    • v.17 no.12
    • /
    • pp.2785-2792
    • /
    • 2013
  • An elevator is driven by the friction between the pulley and wire rope. A balancing counter weight is connected to the elevator car with a wire rope. This structure is essential to drive elevators while it always has weight unbalance problems on each side. The overbalance-ratio of elevators may be an important factor for safety and structural efficiency; however, it is not yet clearly defined in the Requirements of Korea Elevator Inspection. This paper describes these "weight unbalance ratio" for control of elevators to reduce the number of accidents. It includes the analysis of current elevator maintenance situations and also proposes some fundamental improvement schemes for safety.