• 제목/요약/키워드: International Safety Standard Harmonization

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이륜자동차의 전자파 적합성과 안전기준에 관한 연구 (A Study on Electromagnetic Compatibility and Safety Standards for Motorcycles)

  • 우현구;용부중
    • 자동차안전학회지
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    • 제11권1호
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    • pp.17-22
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    • 2019
  • Nowadays many two-wheeled motorcycles are used in leisure and express delivery industries. But studies of the electromagentic compatibility on motorcycles have seldom been performed and published. This paper has studied the electromagnetic safety of motorcycles considering international and domestic regulations and standards. Also, a series of experiments have been performed to evaluate the level of electromagnetic compatibility of commercially available motorcycles. As a result, detailed experimental procedures are proposed to secure the electromagnetic safety and can be used to confirm or revise the Korea Motor Vehicle Safety Standards.

자동차 안전기준 체계 정비방안 연구 (A Study on Improvement Scheme for Korea's Motor Vehicle Safety Standards System)

  • 김규현
    • 자동차안전학회지
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    • 제13권3호
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    • pp.95-101
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    • 2021
  • The Korea's safety standards for vehicle have been strengthened to reduce casualties from traffic accidents since 1962. The standards have a rather complicated structure. The safety standards are composed of the main text and asterisks, and the safety standard implementation rules are composed of the main text, asterisks and appendices, and items of the same name are stipulated in other chapters within the safety standards. This study is to suggest improvement measures such as simplifying the structure of these safety standards and integrating safety standard items with the same name. Through this, users' understanding of the standards will be improved, and it is expected that the system will be more efficient such as securing safety quickly through harmonization with international standards following the development of rapidly changing new technologies such as automated vehicles.

노출기준 설정 화학물질의 CMR물질 정보 제공에 관한 연구 (A study on the provide of CMR substances information for Threshold Limit Values (TLVs) chemicals in KMoEL)

  • 이권섭;이혜진;이종한
    • 한국산업보건학회지
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    • 제22권1호
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    • pp.82-90
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    • 2012
  • Objectives: This study was performed to provide workplaces with political guidelines that apply international CMRs (Carcinogens, Mutagens, Reproductive toxins) information to Public Notice of TLVs (Threshold Limit Values). We analyzed information supply status about CMRs of international agencies and compared substances for which TLVs are set in KMoEL (Ministry of Employment and Labor in Korea). Methods: We referred to the reliable literature about classification criteria of CMRs corresponding to UN GHS (Globally Harmonized System of classification and Labeling of chemicals) and Public Notice No. 2009-68 'Standard for Classification, Labeling of Chemical Substance and Material Safety Data Sheet' in KMoEL. The classification system of CMRs in professional organizations (IARC, NTP, ACGIH, EU ECHA, KMoEL, etc.) was investigated through the internet and literature. Conclusions: 191 chemical substances among total 650 substances with TLVs are classified as carcinogens. Also, 43 substances classified as mutagens, and 44 as reproductive toxicants. These results suggest that the information of CMRs in Public Notice of TLV will be reorganized to 191 carcinogens, 43 mutagens, and 44 reproductive toxicants.

KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준: 진단용 X선 장치의 방사선 방어를 적용한 진단용 방사선 발생장치의 검사기준 개선안 (Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment)

  • 박혜민;김정민;김정수;김성옥;최영민
    • 대한방사선기술학회지:방사선기술과학
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    • 제41권5호
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    • pp.493-504
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    • 2018
  • The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.

물질안전보건자료 대상물질의 유해성 분류기준 적용 연구 (Study on applying to Hazard Classification Criteria of Chemicals subject to Material Safety Data Sheets)

  • 이혜진;이나루;이인섭
    • 한국산업보건학회지
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    • 제30권3호
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    • pp.280-291
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    • 2020
  • Objectives: Hazard classification is a controversial issue in the new MSDS system in which chemical companies have to prepare and submit MSDS for chemicals that they manufacture or import to the competent authorities according to the amended Occupational Safety and Health Act. The aim of this study is to suggest how to apply and manage harmonized hazard classification criteria and results by investigating current hazard classification systems and trends. Methods: The domestic issues about different hazard classification criteria and results were investigated by reviewing the literature and business outcomes regarding KOSHA. We also checked official and unofficial reports from the UN to understand international discussion about the topic. Chemical hazard classification results from agencies providing chemical information were analyzed to compare a harmonized rate between classifications. Furthermore, a field survey of a few chemical companies was conducted. Results: Under the related competent authorities, an integrated standard proposal was developed to harmonize the domestic hazard classification criteria. Although harmonized chemical information is strongly needed, we recognized the uncertainty and difficulty of harmonized hazard classification from the UN global list project review. In practice the harmonization rate of the classification was generally low between the classification in KOSHA, MoE, and EU CLP. Among hazard classes, health hazards largely led the disharmony. The field survey revealed a change of perception that the main body of chemical information production is manufacturers. Approaches and solutions about hazard classification issues differed depending on business size, types of chemical handling, and other factors. Conclusions: We proposed reasonable ways by time and step to apply hazard classification in the new MSDS system. Chemical manufacturers should make and offer chemical information including responsible hazard classifications. The government should primarily accept these classifications, evaluate them by priority, and support or supervise workplaces in order to communicate reliable chemical information.

경영컨설팅 방법론을 이용한 감염병 실험실의 생물안전 위해성평가 조화기준 도출 (Development of a Harmonization Standard for Biosafety Risk Assessment of Infectious Disease Laboratories using Management Consulting Methodology)

  • 유민수
    • 한국환경보건학회지
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    • 제40권3호
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    • pp.187-203
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    • 2014
  • Objectives: As the demand to deal with pathogens in domestic research institutions has expanded and biological accidents have increased, the need for systematic biosafety management in infectious disease laboratories has grown. According to international standards, risk assessment (RA) is required for biosafety management. However, RA criteria have not been clearly established in Korea, so to this end I have attempted to determine RA criteria meeting international levels Methods: In order to provide RA criteria for application, I analyzed the RA criteria in use in the U.S., Europe and at international organizations. In order to ensure the public nature of the RA criteria, I constructed the research model through modified management consulting methodology reflecting the model of Radnor and O'Mahoney. Results: According to the results of the study, existing laboratory biosafety regulations were comparable to domestic laboratory safety laws. Existing laboratory biosafety standards that are designed around risk factors were found to be insufficient. An RA case to be carried out in infectious disease laboratories at the National Institute of Health of KCDC was identified. Conclusion: To establish a systematic risk management system meeting international standards, it was necessary first to harmonize the systems of national and international standards. In addition, in order to provide specific biosafety management on-site, I recognized a need for methodology and planning strategies to discover biosafety management so that it can be carried out as required through the RA of individual laboratories.

잔류물질분석의 국제공인시험기관 인정 관련 고찰 (Study on international accreditation for residue analysis laboratory)

  • 김미경;조병훈;김동규;윤선종;임채미;박수정;김희진;김연희;김수연;윤소미;권진욱;손성완;정갑수;이주호;강문일
    • 대한수의학회지
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    • 제46권4호
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    • pp.295-304
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    • 2006
  • Residual materials such as veterinary drugs, environmental contaminants, and pesticides are affecting food safety. High resolution techniques and quality controls are needed to analyze these materials from part per million to part per trillion quantities in food. In order to achieve quality results, standardized methods and techniques are required. Our laboratories were prepared to obtain a certificate of accreditation for ISO/IEC 17025 in the analytical criteria of animal drugs, dioxins, pesticides, and heavy metals. ISO together with IEC has built a strategic partnership with the World Trade Organization with the common goal of promoting a free and fair global trading system. ISO collaborates with the United Nations Organization and its specialized agencies and commissions, particularly those involved in the harmonization of regulations and public policies including the World Health Organization and CODEX Alimentarius for food safety measurement, management and traceability. Our goal was to have high quality analysts, proper analytical methods, good laboratory facilities, and safety systems within guidelines of ISO/IEC 17025. All staff members took requirement exams. We applied proficiency tests in the analysis of veterinary drugs (nitrofuran metabolites, sulfonamide and tetracyclines), dioxins, organophosphorus pesticides, and heavy metals (Cd, Pb, As) to the Food Analysis Performance Assessment Scheme (FAPAS) at Central Science Laboratory, Department for Environment Food and Rural Affairs (DEFRA), England. The results were very satisfactory. All documents were prepared, including system management, laboratory management, standard operational procedures for testing, reporting, and more. The criteria encompassed the requirements of ISO/IEC 17025:1999. Finally, the Korea Laboratory Accreditation Scheme (KOLAS) accredited our testing laboratories in accordance with the provisions of Article 23 of the National Standards Act. The accreditation will give us the benefit of becoming a regional reference laboratory in Asia.

김밥의 자가품질검사 항목설정의 합리화 방안 (Ways to Improve the Efficiency of the Self Quality Inspection Analysis for RTE Kimbab)

  • 김선아;임송수
    • 산경연구논집
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    • 제10권9호
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    • pp.37-43
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    • 2019
  • 이 논문은 즉석섭취식품으로 분류되는 김밥용 김에 관한 자가품질검사의 개선안을 제시하였다. 김밥용 김에 적용하는 검사항목 중 장염비브리오균은 3가지 측면에서 적합하지 않다. 첫째, 선행연구 가운데 김밥용 김에서 장염비브리오균을 발견한 사례가 전무하다. 둘째, 전수조사 성격의 자가품질검사 부정합 내역(2015~16년)에 김밥용 김이 적시된 적이 없다. 셋째, 국제기준인 CODEX 규정은 해조류에 장염비브리오균 검사 의무를 부여하지 않는다. 끝으로, 수출용 김과 조미김 및 기타 수산물가공품 유형에 해당 검사가 면제된다. 이에 따라 김밥용 김에 대한 장염비브리오균 검사의무의 면제는 타당하며 그에 따른 경제적 이득은, 특히 영세업체에 클 것으로 추정된다. 2018년 3월 중 총 75곳의 자가품질 검사기관에 대한 전화 및 서류조사 결과 업체당 수수료 절약 규모는 업체당 연평균 13만 원에 이를 것으로 산출하였다. 또한, 검사의 투명성과 효율을 제고하기 위해서는 검사기관 간 수수료의 조화가 필요할 것으로 판명되었다.

오크라 분말의 Quercetin-3-𝑜-Gentiobioside 및 Isoquercitrin의 분석법 개선 및 검증 (Improvement and Validation of an Analytical Method for Quercetin-3-𝑜-gentiobioside and Isoquercitrin in Abelmoschus esculentus L. Moench)

  • 한웅호;최선일;문효;이세정;진희구;오현지;조세행;이부용;이옥환
    • 한국식품위생안전성학회지
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    • 제37권2호
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    • pp.39-45
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    • 2022
  • 본 연구에서는 오크라를 이용하여 건강기능식품 개발 시원료의 표준화를 위하여 HPLC-PDA를 이용하여 지표성분 quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 기존 보고된 분석법을 개선하고 분석법에 대한 유효성 검증을 실시하였다. 분석법의 유효성 검증은 ICH 가이드라인에 근거하여 특이성, 직선성, 정확성, 정밀성, 검출한계 및 정량한계를 통해 신뢰성 및 타당성을 검증하였다. HPLC를 이용한 분석방법에서 표준용액의 지표성분 피크 머무름 시간과 오크라 분말 시료의 지표성분 피크 머무름 시간 및 spectrum의 확인결과 모두 일치하므로 특이성을 확인하였다. Quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 검량선은 1에 가까운 높은 상관계수 값(0.9999, 0.9999)으로 우수한 직선성을 확인할 수 있었으며 분석에 적합함을 알 수 있었다. 농도를 알고 있는 오크라 분말 시료에 표준물질을 저, 중, 고농도로 제조한 후 첨가하여 정밀성 및 정확성을 계산하였다. Quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 정밀성은 일내, 일간 정밀성으로 확인하였으며, quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 일내 정밀성은 각각 0.50-1.48%, 0.77-2.82% 수준으로 확인되었으며, 일간 정밀성은 0.07-3.37%, 0.58-1.37% 수준으로 5% 이하의 우수한 정밀성을 보였다. 정확성 측정결과 quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 일내 정확성은 104.87-109.64%, 108.50-109.70%를 나타내었으며, 일간 정확성은 106.69-111.08%, 106.85-109.06% 수준으로 우수한 정확성을 나타내었다. Quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 검출한계는 각각 0.24 ㎍/mL, 0.16 ㎍/mL이었고 정량한계는 0.71 ㎍/mL, 0.49 ㎍/mL로 나타내어, 낮은 농도에서도 검출이 가능함을 확인하였다. 확립된 분석법은 특이성, 직선성, 정밀성, 정확성, 검출한계 및 정량한계에 대한 분석법 검증결과가 모두 우수한 분석법임을 증명하였다. 또한 검증된 분석법을 이용하여 오크라 분말 시료 중 quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 함량분석 결과, quercetin-3-𝑜-gentiobioside은 1.49±0.01 mg/dry weight g, isoquercitrin은 1.39±0.01 mg/dry weight g의 함량을 함유하고 있는 것으로 분석되었다. 본 연구는 HPLC-PDA를 이용한 오크라의 지표성분인 quercetin-3-𝑜-gentiobioside 및 isoquercitrin의 동시 분석방법이 과학적으로 신뢰성이 있는 적합한 분석방법임이 검증되었다.