• 제목/요약/키워드: Testing Standards

검색결과 740건 처리시간 0.029초

Guidelines for Manufacturing and Application of Organoids: Skin

  • Seunghee Lee;Yeri Alice Rim;Juryun Kim;Su Hyon Lee;Hye Jung Park;Hyounwoo Kim;Sun-Ju Ahn;Ji Hyeon Ju
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.182-193
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    • 2024
  • To address the limitations of animal testing, scientific research is increasingly focused on developing alternative testing methods. These alternative tests utilize cells or tissues derived from animals or humans for in vitro testing, as well as artificial tissues and organoids. In western countries, animal testing for cosmetics has been banned, leading to the adoption of artificial skin for toxicity evaluation, such as skin corrosion and irritation assessments. Standard guidelines for skin organoid technology becomes necessary to ensure consistent data and evaluation in replacing animal testing with in vitro methods. These guidelines encompass aspects such as cell sourcing, culture techniques, quality requirements and assessment, storage and preservation, and organoid-based assays.

Guidelines for Manufacturing and Application of Organoids: Liver

  • Hye-Ran Moon;Seon Ju Mun;Tae Hun Kim;Hyemin Kim;Dukjin Kang;Suran Kim;Ji Hyun Shin;Dongho Choi;Sun-Ju Ahn;Myung Jin Son
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.120-129
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    • 2024
  • Recent amendments to regulatory frameworks have placed a greater emphasis on the utilization of in vitro testing platforms for preclinical drug evaluations and toxicity assessments. This requires advanced tissue models capable of accurately replicating liver functions for drug efficacy and toxicity predictions. Liver organoids, derived from human cell sources, offer promise as a reliable platform for drug evaluation. However, there is a lack of standardized quality evaluation methods, which hinders their regulatory acceptance. This paper proposes comprehensive quality standards tailored for liver organoids, addressing cell source validation, organoid generation, and functional assessment. These guidelines aim to enhance reproducibility and accuracy in toxicity testing, thereby accelerating the adoption of organoids as a reliable alternative or complementary tool to animal testing in drug development. The quality standards include criteria for size, cellular composition, gene expression, and functional assays, thus ensuring a robust hepatotoxicity testing platform.

Guidelines for Manufacturing and Application of Organoids: Heart

  • Hyang-Ae Lee;Dong-Hun Woo;Do-Sun Lim;Jisun Oh;C-Yoon Kim;Ok-Nam Bae;Sun-Ju Ahn
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.130-140
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    • 2024
  • Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

실내공기질 공정시험방법과 기준의 동시 개정에 따른 접착제 제품의 TVOC 관리수준 평가 (The TVOC management level evaluation of adhesive product following to simultaneous revision of indoor air quality testing methods and standards)

  • 유지호;박준만;김만구
    • 분석과학
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    • 제23권3호
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    • pp.255-260
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    • 2010
  • 환경부에서는 오염물질 다량 방출 건축자재의 효율적인 관리를 위해 "다중이용시설 등의 실내 공기질 관리법" 중 접착제의 시험방법과 방출관리기준을 동시에 개정하였다. 따라서 기존 관리수준과 개정 관리수준의 직접적인 비교가 불가능하다. 이 연구에서는 접착제의 개정된 시험방법의 각 요소들이 오염물질 방출강도에 미치는 영향들을 기존 시험방법과 비교하여 검토하였다. 이를 통하여 개정된 오염물질 방출관리기준을 평가하였다. 그 결과 접착제는 시험기간의 변경으로 인해 방출강도가 약 2.5배 약화되었고 건조시간의 변경에 따른 방출강도의 차이는 거의 없는 것으로 나타났다. 시험방법의 변경된 내용을 적용한 TVOC 방출 관리기준은 기존 방출 관리기준에 비해 약 2.1배 강화된 것으로 나타났다.

선체구조 모델 데이터의 교환 표준에 따른 적합성 시험 기준의 개발 (Development of Conformance Testing Criteria for STEP AP218 (Ship Structure))

  • 황호진
    • 한국해양공학회지
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    • 제24권2호
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    • pp.74-81
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    • 2010
  • Ship STEP is the international standard for the exchange of ship modeling data between heterogeneous systems. It is expected that STEP AP218 can be used for seamless data exchange between various CAD/CAM/CAE systems used in the shipbuilding design process. Although the conformance assessment for standards would maximize the performance and confidence about data exchanges, most research has been directed toward interoperability testing. ISO SC4/TC184 only provides the method for conformance testing, and it can be used with test cases on application protocols. Even though standards have been defined for conformance assessment and testing, there is no organization or association. CAD vendors have focused on interoperability testing for evaluation of the performance of their systems. In this paper, the conformance testing criteria for AP218 have been developed with abstract test cases of ship structures. The requested STEP translator was also reviewed with a developed item pool of testing criteria. The criteria methodology would be a guideline for the development of translators and interfaces. The item pool method of testing criteria for conformance assessment would increase performance and efficiency of data translators for Ship STEP and other standards.

고전압 개폐장치의 보조회로 및 제어회로에 대한 환경시험 검토(2) (A Study on Environmental Tests for Auxiliary and contol circuits of HV Switchgears and controlgears(2))

  • 이정기;박영창;정주영;김익수
    • 대한전기학회:학술대회논문집
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    • 대한전기학회 2009년도 제40회 하계학술대회
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    • pp.1443_1444
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    • 2009
  • A study on the environmental tests for auxiliary and control circuits of high voltage switchgears, especially testing condition and requirements, according to the relevant international standards has been briefly reviewed in this paper. As the highest supply voltage of electric power systems have been progressed, testing techniques and testing standards such IEC codes improved and revised keeping step with it. Especially IEC 62271 series, which are applicable to the HV-class switchgears and controlgears have been revised in 2008 newly. In this paper, the special consideration and background information of environmental testing condition with mechanical operating performance, e.g. operation in a higher and lower ambient temperature, for the auxiliary and control circuits of switchgears and controlgears and considerable investigation to the related international standards have been provided. Examples of testing performed were showed and analysis of their test results have been described.

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시간 정의구역 Born 근사에 의한 탄성매질에서의 결함에 관한 연구 (Characterization of Flaws in the Elastic Medium by Time Domain Born Approximation)

  • 이재열;이세경;이재옥;김영환
    • 비파괴검사학회지
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    • 제3권1호
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    • pp.5-11
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    • 1983
  • The impulse response function are studied using time domain Born approximation in two cases; firstly when the material parameters of a flaw are constant, secondly when the parameters are varying with positions. From the impulse response functions, characteristics can be learned about a flaw with high symmetry.

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후면투사식 CRT 고화질 텔레비전용 광학엔진의 변조전달함수 측정을 위한 후방검사 변조전달함수 측정법 (Backward Testing Method of MTF measurement for optical engine of CRT of rear projection HDTV)

  • 송종섭;조재흥;홍성목;이윤우;송재봉;이회윤;이인원
    • 한국광학회지
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    • 제16권1호
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    • pp.56-62
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    • 2005
  • 후면투사방식의 CRT(Cathod Ray Tube) 고화질 텔레비젼용 광학엔진은 큰 화면과 굽은 필드 때문에 일반적인 전방검사 MTF(modulation transfer function)로는 측정이 어렵다. 이러한 광학엔진의 MTF를 측정하기 위하여 광학엔진이 놓인 물체면과 상분석기의 위치를 서로 바꾸는 후방검사 MTF방법을 제안하고 이에 따른 MTF 측정장비를 구성하였다. 이러한 CRT HDTV용 광학엔진을 위한 후방검사 MTF측정법은 작은 수치개구(NA), 낮은 분해능, 긴 초점심도들 때문에 정밀도가 낮아지는 전방검사 MTF 측정법보다 사용하기가 훨씬 더 좋으며, 정렬이 매우 용이하고 측정반복성이 매우 좋다. 이 방법으로 측정한 MTF값과 설계된 MTF를 비교함으로써 이 방법의 신뢰성을 확인하였다.