• The Journal of Korean Physical Therapy
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• v.23 no.3
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• pp.37-42
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• 2011

Purpose: The principal objective of this study was to evaluate the power output of ultrasound in Korean clinics and compare the value with Korean and global standards. Methods: A total of 69 units were measured for ultrasound power output. The normal range of power output level was ${\pm}30%$ of the output set according to KFDA standards. Device model, manufacturer, ERA, and BNR were obtained via simple questionnaires. A portable ultrasound power meter was used for output measurement. Results: 37 machines, with reported ERA values, were assessed for power output per unit area. Of these machines, 13 (37.14%) were considered to be compliant with US FDA standards at 0.5, 1.0, 1.5, $20W/cm^2$ and 18 (51.43%) were considered within KFDA standards. The remainder of the machines were outside the standard error and evidenced irregular output levels, even though most of them were the same model. Conclusion: Appropriate ultrasound intensity is incredibly important for safety and effective use. Therefore, the KFDA standards regarding ultrasound may require revision in light of global standards, including BNR and ERA additionally, attention should be paid to regular calibration for safe use in clinical practice.

• YAKHAK HOEJI
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• v.45 no.2
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• pp.227-236
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• 2001

The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone (somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control (NIBSC). The candidate KFDA reference standard for somatropin (designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01 mg somatropin per ampoule. Data from the study also yielded mean values of 0.39 $\pm$ 0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 $\pm$ 1.29% for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 aganist IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.

• Korean Journal of Pharmacognosy
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• v.35 no.4 s.139
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• pp.276-282
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• 2004

This study has been conducted to investigate the amount of residual sulfur dioxide for herbal medicines of 30 species which are purchased in 13 different regions (Bonghwa, Busan, Chunju, Jecheun, Kwangiu, Keumsan, Seoul, Taeku, Cheungdu, Xian, Beijing, Tokyo and Osaka). The sulfur dioxide residues were determined in the collected 386 samples by the modified Monier-Williams method. The residues of sulfur dioxide in 386 samples ranged from ND (under detection limit) to 2808 ppm. The sulfur dioxide in Cassiae Semon, Cinnamomi Ramulus, Cervi Cornu, Hoelen, Crataegi Fructus, Artemisiae Argyi Herba, Scolopendrae Corpus, Schizandrae Fructus and Cyperi Rhizoma were detected under the detection limit regardless of the collected regions. The sulfur dioxide residues in herbal medicines collected in domestic regions were relatively lower than those in foreign regions. There are no standards for sulfur dioxide residual limits of herbal medicines in Korea. This results will provide the scientific basis for the standardization of sulfur dioxide residues in Korea Pharmacopoeia.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• Journal of radiological science and technology
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• v.36 no.1
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• pp.1-10
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• 2013

IEC publications have applied in many countries all over the world such as Europe or Japan and these also have been published as in dustrial standards (KS) and notifications of Korea Food and Drug Administration (KFDA) in Korea. As the general standard of IEC 60601 series for medical electric (ME) equipment was revised as $3^{rd}$ edition in 2005, additional and particular standards have been revised or established newly. Under these circumstances, it is importance for manufacturing and assembling companies or authorized testing companies to understand the trend for revisions of IEC publications. Therefore in this study, the latest version of 3 IEC standards related to medical X-ray equipment : IEC 60601-2-44 for X-ray equipment for computed tomography (CT), IEC 60601-2-45 for mammographic X-ray equipment and IEC 60601-2-54 for X-ray equipment for radiography or radioscopy were covered and analyzed for trends and features accompanied by revision based on IEC 60601-1 $3^{rd}$ Ed. As KFDA notifications in force have referred to the particular standards based on 2nd edition of IEC 60601-1, those revised version of 3 particular standards were compared to KFDA notifications in force. The features of the latest standards applying IEC 60601-1 $3^{rd}$ Ed were shown as following: 1) Requirements for mechanical hazards, especially (motorized) moving parts were emphasized. 2) Indication and recording of patient dose were required. 3) Risk management process was introduced and enabled to monitor potential risks systematically. 4) DR system (digital radiography system) as well as analogue system (film-screen system) was included in the scope. Presently, KFDA will revise the notifications applying the particular standards based on IEC 60601-1 $3^{rd}$ Ed in a few years. Therefore the features of particular standards applying IEC 60601-1 $3^{rd}$ Ed was expected to help manufacturers, assemblers or testing companies of medical electric equipment understand IEC publications or KFDA notifications slated to be published.

• Korean Journal of Digital Imaging in Medicine
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• v.11 no.2
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• pp.69-77
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• 2009

This study gives an account of the collateral standards in IEC 60601-1-3: 2008 specifying the general requirements for basic safety and essential performance of diagnostic X-ray equipment regarding radiation protection as it pertains to the production of X-rays. The collateral standards establish general requirements for safety regarding ionization radiation in diagnostic radiation systems and describe a verifiable evaluation method of suitable requirements regarding control over the lowest possible dose equivalent for patients, radiologic technologists, and others. The particular standards for each equipment can be determined by the general requirements in the collateral standard and the particular standard is followed in the risk management file. The guidelines for radiation safety of diagnostic radiation systems is written up in ISO 13485, ISO 14971, IEC 60601-1-3(2002)1st edition, medical electric equipment part 1-3, and the general requirements for safety-collateral standards: programmable electrical medical systems. Therefore the diagnostic radiation system protects citizens' health rights with the establishment and revisions of laws and standards for diagnostic radiation systems as a background for the general requirements of radiation safe guards applies, as an international trend, standards regarding the medical radiation safety management. The diagnostic radiation system will also assure competitive power through a conforming evaluation unifying the differing standards, technical specifications, and recognized processes.

• Korean Journal of Food Science and Technology
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• v.38 no.5
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• pp.605-608
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• 2006

Genetically modified (GM) ingredients found in imported raw materials and processed foods were monitored in the province Gyeongin in Korea. The analysis was performed according to "Testing methods for genetically modified foods of food standards and specifications" established in Korea. We received 120 items from the Gyeongin Regional KFDA. Only two of the 120 items analyzed in the samples, were contaminated with GM ingredients. However, we could not analyze the internal standard gene from 12 processed foods. We found that the extracted total DNA of the above 12 samples were extracted and found to be degraded. The total DNA contained a very small fragment of less than 300 base pair. Therefore, it seems that the total DNA is not large enough to serve as the template DNA for PCR analysis.

• Journal of rehabilitation welfare engineering & assistive technology
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• v.3 no.1
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• pp.35-40
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• 2009

Electrically operated hospital bed and operating table are useful devices to care patients and to keep postures of them in medical treatment. However they have the risk of physical injury due to various functions and mechanisms consisting of them. In this paper we propose particular requirements for the safety and test methods of electrically operated hospital beds and operating table classified into medical devices. Each items are developed based on international standards. The results of this study can be used for developing internationally harmonized standards for the approval of Korea Food and Drug Administration (KFDA).

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.43-43
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• 2003

The mission of pharmacopoeia is to promote the public health by establishing and disseminating the officially recognized standards of the quality of medicines and authoritative information about the use of them and other health care technologies by health professionals, patients, and consumers. Korean Pharmacopoeia was first established on October 10, 1958 and revised per 5 years. 8th edition was published December 30, 2002 and we are preparing English edition. (omitted)

• Korean Journal of Food Science and Technology
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• v.37 no.6
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• pp.889-892
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• 2005

Standardized method based on extraction, filtration, and gas chromatography (GC) was developed far propylene glycol analysis to set hygienic norm of safety measure for foods under governmental control. Various columns were tested fur propylene glycol analysis by GC with flame ionization detector. Known amount of propylene glycol was spiked into wheat flour dough and analyzed by developed method. Results showed 101.60% recovery rate for propylene glycol with HP-5 column. Reproducibility test of standards recorded 0.30 for standard variation and 0,42% for relative variation. Using analytical method established, contents of propylene glycol in more than hundred different foods were monitored. Propylene glycol was detected in most foods, indicating propylene glycol is not only commonly added during food preparation, but also is contained naturally in food.