• The Korean Journal of Health Service Management
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• v.7 no.3
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• YAKHAK HOEJI
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• v.58 no.1
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• pp.53-57
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• 2014

In recent, the abuse of newly-emerging psychoactive drugs, ('designer drugs') is a rapidly increasing problem in Korean society. Quantitative-structure activity relationship (QSAR) is an alternative method to predict bioactivities of new abused compounds. In this study, cathinone-related new designer drugs, 4-methylbuphedrone and 4-methoxy-N,N-dimethylcathinone were tested for prediction of the bioactivity with QSAR model. The bioactivity of 4-methylbuphedrone and 4-methoxy-N,N-dimethylcathinone was similar to those of methylone. These results suggest that the prediction with QSAR model may provide scientific evidences for regulatory decision.

• Journal of Environmental Impact Assessment
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• v.2 no.2
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• pp.55-58
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• 1993

After establishing the EIA(Environmental Impact Assessment) act in the Federal Republic of Germany there still remain methodical and substantial deficits. So nearly every environmental impact study went to be a matter of experiments. The requirement for standardization of data sampling and evaluation has permanently been increasing. This is meant to ensure quality standards for the assessment of environmental impacts as well as to maintain reliability required by the projecting company. Such a harmonization is of special importance because of the strongly accelerated expansion of traffic infrastructure caused by the reunification of Germany. That is why the guideline "EIA carried out" for the German Railways company is in process of development This guideline, focussing on practical demands, comprises impacts of railways, adequate sets of indicators, feasible tools for the prognosis and evaluation of environmental reactions. "EIA carried out" will be introduced not only as a manual but also through workshops and pilot studies.

• Journal of the Korean Society of Systems Engineering
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• v.3 no.1
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• pp.1-7
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• 2007

For the systems engineering process-based development, all requirements of 'Smart UAV Development Program' have been constructed as the database of CORE(R), computer aided systems engineering tool. In this paper, the construction and application of model-based test & evaluation system using those database is described, which prevents omitting essential tests and performing unnecessary rests and enables automatic reflection of database changes and standardization of document formats.

• Proceedings of the KIEE Conference
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• 1996.07b
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• pp.1330-1332
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• 1996

Power telecommunication networks is being increased rapidly in that expansion of power plant according to the growth of electric power supply. The requirement of power plant operation & office automation make it to complex and confusing to operate. So, for the sake of correspond to the change, it is necessary that telecommunication network should be high reliable and managed effectively. In this paper, we suggest total reliability evaluation models for power telecommunication network which is based on the QOS(quality of service) standardization techniques recommanded by ITU-T.

• Bulletin of the Korean Chemical Society
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• v.20 no.8
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• pp.910-916
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• 1999

A current interest in chemistry concerns traceability of analytical measurements to the International System of Units (SI) and the proper estimation of their uncertainties in accordance with the internationally agreed guide provided by the International Organization for Standardization (ISO). Isotope dilution mass spectrometry (IDMS) is regarded as a primary method, which make the measurement results traceable to SI units without significant empirical correction factors. Our laboratory, as the national standards institute of Korea, participated in an intercomparison of environmental analysis, pp'-DDE in corn oil, which was organized by the CCQM under supervision of the CIPM to test feasibility of IDMS as a primary method for the trace analysis of organic compounds. In this report, we provide basic equations used for the calculation of the concentration of the analyte in a sample and a precise description of the processes for the evaluation of the uncertainties of the measurement results. Also, we report the experimental conditions adopted to improve the accuracy of the IDMS measurement. The principles contained in ？？Guide to the Expression of Uncertainty in Measurement'' provided by ISO are followed for the uncertainty evaluation.

• The Journal of the Acoustical Society of Korea
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• v.42 no.2
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• pp.133-142
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• 2023

The office environment is changing according to work types, Information Technology (IT) advancements, and the Coronavirus disease (COVID)-19 situation. In order for office space users to perform their tasks comfortably and efficiently, it is necessary to secure individual privacy as well as easy communication among members. In Korea, the demand for improving the acoustic performance of office spaces is also increasing, but the related performance criteria and guidelines have not been established. In this study, standardization of office space acoustic performance measurement and evaluation methods and European countries' acoustic performance criteria were compared and reviewed. It is proposed to comprehensively review international standardization trends and acoustic performance standards in each country and to establish and utilize criteria for evaluating the acoustic performance and satisfaction of office spaces in Korea through our survey. Considering the international standardization direction and compatibility with communication and Public Address (PA) systems, it is appropriate to establish criteria using the speech transmission index or Speech Transmission Index (STI) application index. This criterion will be highly utilizable and compatible. In addition, since the office furniture industry is interested in improving the acoustic performance of office space, it is necessary to establish a labelling system for speech level reduction of office furniture.

• Quality Improvement in Health Care
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• v.9 no.2
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• pp.176-197
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• 2002

Backgound : This study is to suggest the standardized format of the clinical sheets and the standardized items of every clinical sheet. The standardization of the medical records will increase the faithfullnes of the contents in them and it will contribute to construct the good health information system. Method : From Jan. 1st. 2001 to March 31st 2001, we gathered as many paper clinical sheets as possible by every class of institutions to review the faithfulness of the clinical contents in them. Clinical sheets of 9 tertiary care hospitals, 6 general hospitals and 56 clinics were gathered. Two experienced medical record administrators reviewed them. The review focus was to check whether the items recommend by the hospital standardization review criteria and hospital service evaluation organization were appeared in the clinical sheets and whether the contents of every item were written. Results : Tertiary care hospitals; In case of administrative data, the contents were filled well if the items were fixed. The clinical data like C.C, history,physical examiniation were filled well, but if the items were not fixed, some items were omitted. The result is that more items are to be filled if they are fixed. General hospitals Administrative data were filled more than 50%. Final diagnosis was filled about 66.7%.But other clinical data were not filled well and not many clinical related items were appeared in the sheets.In the legal point of view, the reason for visiting hosptals or the right diagnosis, patient condition at discharge could not be confirmed well.In surgery cases, surgical procedures could not be confirmed well as many surgical related information(surgery time, fluids and blood, number of sponges, biopsy, etc) were omitted. Clinics More than 70% administrative data were filled and fixed as items. Among the clinical related data, laboratory result was the most credible data. But without the right diagnosis, drug orders were given and doctors' written signatures were not appeared over 96.4%. So the clinical sheets cannot be used as a legal document. Conculusion : There was a tendency that the contents were filled well if the items were fixed in the documents, We also suggest a clinical check list to review the completeness and faithfulness of the clinical sheets. If many hospitals use the suggested clincal check list and if they make the necessary items fixed in the clinical sheets, the quality of the medical record will increase dramatically.

• Journal of dental hygiene science
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• v.17 no.1
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• pp.1-11
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• 2017

There are 82 dental hygiene departments and clinical training institutes across the country with a very wide range of clinical practice content and evaluation methods, making standardization difficult. Therefore, there is a need to establish a standard protocol outlining clinical practice content and evaluation methods for systematic and efficient operation of clinical practice. Thus, this study attempted to propose such a protocol for standardization of dental hygiene clinical practice in dental clinics and hospitals to examine the contents of clinical practice by reviewing relevant literature, and relating it to professional practice within the dental hygienic curriculum to facilitate enhancement of expertise. Clinical practice content was extracted from 74 cases, and was consisted of classifying mandatory and optional clinical practice, training time, and activity methods for each component. To standardize effective clinical practice, it is necessary to organize the components acquired in the course of clinical dentistry training in line with their arrangement on each university's curriculum, in order to learn all components step by step. To do this, it is necessary to present a standardized clinical practice protocol and a organic cooperation between educational institutions and clinical training institutions.

• Journal of Food Hygiene and Safety
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• v.23 no.3
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• pp.206-211
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• 2008

Photostimulated luminescence(PSL)-Thermoluminescence(TL) combined analysis was applied to detect whether composite seasoning products and spices were irradiated or not. Samples were irradiated with $^{60}Co$ at $0{\sim}7$ kGy. A total of 12 different samples(6 of composite seasoning products and 6 of spices) was examined. Depending on the PSL results, TL analysis was performed. In case of both PSL positive(${\geq}5,000$ counts) and intermediate($700{\sim}5000$ counts), TL analysis had to be performed to confirm the result of PSL. Using TL, the shape of the glow curve(Glow 1) made it possible to identify the irradiated samples. In addition, The TL glow ratio(Glow 1/Glow 2) obtained by normalization was less than 0.1 for the non-irradiated samples and ${\geq}0.29$ for irradiated ones, respectively.