• Title/Summary/Keyword: Process guideline

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Methods of Extracting and Providing R&D Documentation Guideline for Licensing Medical Device Software

  • Kim, DongYeop;Lee, Byungjeong;Lee, Jung-Won
    • Journal of Internet Computing and Services
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    • v.20 no.3
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    • pp.69-75
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    • 2019
  • The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

A Study on the Comparison of System and Implications of Health Care Facility Guidelines by Major Countries - Focused on US, Australia, UK (주요 국가별 보건의료시설 가이드라인의 체계 비교 및 시사점 연구 - 미국, 호주, 영국을 중심으로)

  • Lee, Seung Ji;Kim, Mi Ae
    • Journal of The Korea Institute of Healthcare Architecture
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    • v.26 no.3
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    • pp.27-35
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    • 2020
  • Purpose: A solid system in the process of establishing guidelines can increase social acceptance and utilization. The paper aims to comparatively analyze the system in which guidelines for health care facilities in the US, Australia, and the UK and suggest implications for Korea. Method: It conducted literature analysis of the system in the framework of composition, governance, and procedure for the Facility Guidelines Institute's Guideline for US, Australia's Australasian Health Facility Guidelines for Australia, and Health Building Notes for UK. Results and Implications: First, in terms of composition, the guidelines for health care facilities can be divided into composition by space and composition by issue. It is proposed to establish a system that space and issues are clearly separated, such as Australia's AusHGF, and complete it step by step. Second, in terms of governance, despite the fact that the medical supply is privately oriented, the medical system is controlled by the government in Korea. Therefore, it is suggested to form a separate organization in the public sector that establishes, researches, and revises the guideline that will serve as a focal point for experts in various fields to participate. Third, in terms of procedure, it is suggested to establish a guideline that reflects the experiences and demands of consumers by clearly organizing procedures including collecting opinions.

A Study on the Selection of Learning Theories and Representation Techniques for Online Education -with an Emphasis on Application of Guideline to CAI- (온라인교육을 위한 학습이론과 멀티미디어 표현기법의 선택에 관한 연구 -CAI의 형태에 따른 적용을 중심으로-)

  • 김소영
    • Archives of design research
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    • v.15 no.1
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    • pp.113-122
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    • 2002
  • This thesis is focused on online education and proposes a guideline for selecting teaming theories and multimedia representation without difficulty. On the first, consideration of learning theories and analysis of multimedia properties are made, and from these results guidelines are formed. Then they are applied to each 6 types of CAI. Objectivism and constructivism could be used for the basic framework of CAI. The former is suitable for reed, sequential, structural, and passive learning style and the latter is suitable for selectable, unstructural, active, self-controled, learning style. And the quideline for selecting multimedia representation is made out of the properties of media, learners(cognitive model, proficiency, acceptance), and teaming contents. On the basis of guideline obtaining from the previous process, I suggest mosts suitable conditions for each 6 types of CAI available today. Those conditions are consist of learning theories, media selection, levels of learners, and categories and properties of teaming contents.

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Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline (침구임상시험 가이드라인 개발과정에서 IRB의 윤리적·과학적 지적사항 사례 조사 연구)

  • Leem, Jung Tae;Lee, Seung Hoon;Han, Ga Jin;Kim, Eun Jung;Seo, Byung Kwan;Kim, Tae Hun;Lee, Seung Deok;Kim, Jong Uk;Yu, A Mi;Nam, Dong Woo;Lee, Jun Hee
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.11-21
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    • 2015
  • Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

Consolidated Standards of Reporting Trials: The Reporting Guideline for Randomized Controlled Trials (Consolidated Standards of Reporting Trials의 소개: 무작위 대조군 연구의 보고 지침)

  • Jung, Hoi-In;Kim, Hee-Eun
    • Journal of dental hygiene science
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    • v.14 no.3
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    • pp.269-275
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    • 2014
  • Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

Development of the Contents of the Guideline for Dietitians' Knowledge, Attitudes and Practices (KAP) for Sustainable Management at School Foodservice (지속가능경영을 위한 학교급식 영양사의 지식, 태도, 실천 가이드라인 콘텐츠 개발)

  • Yi, Na-Young
    • Journal of the Korean Society of Food Culture
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    • v.32 no.6
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    • pp.513-526
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    • 2017
  • The purpose of this study is to identify the guideline's contents for dietitians' knowledge, attitudes, and practices (KAP) for the sustainability management at school foodservice. The contents for the guideline were determined by the Delphi technique of two rounds. The Delphi panels of experts were consisted of sixteen school dietitians and fourteen professors of food and nutrition with more than 10 years of experiences by convenience sampling method. Based on the literature, knowledge, attitudes, and practices required for dieticians were classified into menu management, procurement, food production, facility and energy management, waste management, personnel management, and nutrition education. Data were analyzed using SPSS for Windows version 24 and EXCEL to calculate descriptive statistics, content validity ratio, degree of agreement, and degree of convergence. As a result of the second round, the validity scores of 'knows eco-friendly certification standards and labeling systems (4.53 point)' in the knowledge category, and 'tries to purchase local agricultural products (4.87 point)' in the attitude category were the highest. From that round in the practice category, the validity scores of 'plan menus for students' health', 'purchases eco-friendly food', and 'conserves energy in pre-processing and cooking process' were the highest with 4.73 point. Applying the criteria for securing the validity of the contents, the contents of 25 knowledge items, 20 attitude items and 30 practice items were confirmed. The findings of the study can be used to develop the guideline for dietitians required for the sustainability management.

Fintech Industry Invigoration by the De-identification and Linkage Reform of Personal Information (개인정보 비식별 조치와 결합 개선을 통한 핀테크 시장 활성화)

  • Oh, Won-Gyeom;Park, Dea-woo
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2016.10a
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    • pp.340-343
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    • 2016
  • The Korean government published the personal information de-identification guideline on June 2016, which were made by related government ministries. The guideline's objective is that the invigoration of Korean bigdata industry on personal information protection under the current laws. However, if there is some unreasonable method or process in the guideline, it can be an obstacle to bigdata analysis. This article will review the guideline to find defects in methods and processes of de-identification evaluation, de-identification support and data-linkage and then propose the best solutions to improve them. Lastly, this article will mention how these solutions can invigorate Fintech industry.

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Updates of Evidence-Based Nursing Practice Guidelines for Central Venous Infusion Therapy (근거기반 중심정맥 주입요법 간호실무지침 개정)

  • Lim, Kyung Choon;Jeong, Jae Sim;Kim, Kyeong Sug;Kim, Hyun Lim;Kim, Hyun Jeong;Kim, Dong Yeon;Lee, Mi Jeong;Lee, Joohyun
    • Journal of Korean Clinical Nursing Research
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    • v.29 no.1
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    • pp.42-55
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    • 2023
  • Purpose: This study was conducted to update nursing practice guidelines for intravenous infusion published in 2017. Methods: The guideline update process was carried out using 22 steps developed by NICE and SIGN. It was agreed to update domains related to central venous infusion therapy. Contents related to peripheral infusion would be updated later. Results: Updated guidelines for central venous infusion therapy consisted of 6 domains and 195 recommendations. The number of recommendations by domain was 11 for general instruction, 14 for central vascular access devices (CVAD) and add-on devices, 13 for nursing management before insertion of CVAD, 30 for management during insertion of CVAD, 51 for management after insertion of CVAD, and 76 for complications. A grade was 29 (14.9%), B grade was 87 (44.6%), and C grade was 79 (40.5%) in the strength of recommendations. A total of 37 (19.0%) recommendations were newly developed and 23 (12.3%) previous recommendations have been modified. The newly developed recommendations were mainly related to the infection control methods. Conclusion: The updated guideline is focused on safe maintenance of central venous infusion therapy. Through this guideline, it is hoped to minimize the occurrence of complications and improve the standardization and efficiency of nursing practice.

Exergy Analysis of Nitrogen Distillation Column in the Cryogenic Air Separation Process (심랭식공기분리공정에서 질소증류탑의 엑서지 해석)

  • 용평순;이성철
    • Progress in Superconductivity and Cryogenics
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    • v.4 no.1
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    • pp.145-150
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    • 2002
  • The distillation column is one of large energy consumable units in the cryogenic air separation process and the accurate energy analysis of this unit is necessary for choice of energy saving process. In this work, the energy method was adopted for energy analysis of a cryogenic nitrogen distillation column. In order to designing the energy saving distillation column, the exergy distribution of feed air, exergy efficiency and exergy loss for process condition was investigated and the optimal process condition to minimize the exergy loss was found. The result from this work can be used as a guideline for the choice of the process design conditions and efficiency improvement of cryogenic distillation column.

Analysis on the defect and scratch of Chemical Mechanical Polishing Process (CMP 공정의 Defect 및 Scratch의 유형분석)

  • Kim, Hyung-Gon;Kim, Chul-Bok;Kim, Sang-Yong;Lee, Cheol-In;Kim, Tae-Hyung;Chang, Eui-Goo;Seo, Yong-Jin
    • Proceedings of the Korean Institute of Electrical and Electronic Material Engineers Conference
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    • 2001.11b
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    • pp.189-192
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    • 2001
  • Recently, STI process is getting attention as a necessary technology for making high density of semiconductor by devices isolation method. However, it does have various problems caused by CMP nprocess, such as torn oxide defects, nitride residues on oxide, damages of si active region, contaminations due to post-CMP cleaning, difficulty of accurate end point detection in CMP process, etc. In this work, the various defects induced by CMP process was introduced and the above mentioned problems of CMP process was examined in detail. Finally, the guideline of future CMP process was presented to reduce the effects of these defects.

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