• Title/Summary/Keyword: Testing Standards

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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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    • v.17 no.2
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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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    • v.17 no.2
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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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    • v.17 no.2
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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.

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

  • Yoo, Ji-Ho;Park, Joon-Man;Kim, Man-Goo
    • Analytical Science and Technology
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    • v.23 no.3
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    • pp.255-260
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    • 2010
  • The Ministry of Environment simultaneously revised testing methods and emission standards of adhesives product on the "Law of indoor air quality management" for the effective management of the building materials releasing pollutants in great quantities. Accordingly, it is impossible to compare original standards with revised standards directly. The influences of each factor of the revised testing methods of adhesive product on the emission rate of pollutants are reviewed through comparing with the original testing method. Through this study, revised pollutant emission control standards were assessed. With the result that it is found that emission rate of adhesives product is weakened two and half times by changing test period and the emission rate resulting from changing drying time has little difference. As a result of comparing TVOC emission standards with the original testing method considering the modification of testing methods, it is found that the emission standard through this revision is strengthened about 2.1 times more than that of present testing method.

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

  • Hwang, Ho-Jin
    • Journal of Ocean Engineering and Technology
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    • v.24 no.2
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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.

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

  • Lee, Jeong-Gee;Park, Young-Chang;Jeong, Joo-Young;Kim, Ik-Soo
    • Proceedings of the KIEE Conference
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    • 2009.07a
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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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Characterization of Flaws in the Elastic Medium by Time Domain Born Approximation (시간 정의구역 Born 근사에 의한 탄성매질에서의 결함에 관한 연구)

  • Yi, J.Y.;Lee, S.K.;Lee, J.O.;Kim, Y.H.
    • Journal of the Korean Society for Nondestructive Testing
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    • v.3 no.1
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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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Backward Testing Method of MTF measurement for optical engine of CRT of rear projection HDTV (후면투사식 CRT 고화질 텔레비전용 광학엔진의 변조전달함수 측정을 위한 후방검사 변조전달함수 측정법)

  • Song, Jong-Sup;Jo, Jae-Heung;Hong, Sung-Mok;Lee, Yun-Woo;Song, Jae-Bong;Lee, Hoe-Yun;Lee, In-Won
    • Korean Journal of Optics and Photonics
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    • v.16 no.1
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    • pp.56-62
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    • 2005
  • Because of the wide plane and the curved field of CRT rear projection high definition television, its MTF(modulation transfer function) can't be easily measured by the usual forward testing method. Then we propose a backward testing method for the MTF so that the object plane and the image analyzer of forward testing are located at positions opposite each other. We prefer to use the backward testing method because the forward testing method has poor accuracy caused by very small numerical aperture, low spatial resolutions, and long depth of focus. We found that the backward testing method was very easy to align and had high repeatability. We confirmed the confidence of results obtained by the backward testing method in comparison with designed results.