• Journal of the Korean Society of Safety
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• v.30 no.6
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• pp.26-33
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• 2015

This study suggests systematic procedures to improve safety policies on prevention of industrial accidents associated with industrial machines and devices. Specifically, new method of cause analysis of industrial accidents associated with industrial machines and devices is suggested and the related accident data are re-analyzed. Effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, safety device regulation and safety inspection of industrial machines and devices are also analyzed. Based on those analysis results, transition from the current user-oriented safety device regulation to more balanced direct regulations on both manufacturer and user is suggested. Together with severity and frequency of industrial accidents, unit severity and unit frequency need to be taken into account to further assess the risk associated with a particular industrial machine or device. Balance between safety regulations will be realized by proper adjustment of lists of safety certification and inspection, and certification and inspection standards. This will also guarantee the maximum benefit over cost in such safety regulations.

• Safety and Health at Work
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• v.8 no.1
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• pp.59-66
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• 2017

Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Journal of Biomedical Engineering Research
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• v.31 no.2
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• pp.129-133
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• 2010

Intense pulsed light(IPL) is a photo-therapeutic medical device using xenon lamps with optical characteristics of incoherence, defocusing, and polychromatic. IPL has been recognized as a representative medical therapeutic device with growth of domestic skin care market. However, there is no standard regulation manual and guideline to evaluate the safety and performance of IPL. International Electrotechnical Commission(IEC) is being statued "Technical Report IEC TR 60825-16" which is a guidelines for the safe use of intense light source equipment on humans and animals. In this study, a standard Korea Food & Drug Administration (KFDA) regulation for the safety and performance of IPL was suggested by developing minimal evaluation methods for optical parameters of IPL such as output energy density, pulse mode, spot size, wavelength and uniformity of output light. We expect that this study may be a step to statue a standard regulation manual and guideline for IPLs used in domestic.

• Journal of the Korean Society of Safety
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• v.18 no.2
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• pp.22-27
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• 2003

The roller machines installed in the industrial field are operated under hazardous conditions due to no safety devices available, human error during operation, defective safety devices, and inadequate regulation even in case that safety devices are provided. Up to now, most roller machines installed in domestic field are provides with band breaking system as a safety device. In this study, the emergency stop distance is measured within the limit of domestic regulation but violates a foreign regulation(EN1417). Consequently, it is concluded that the roller machines with a band breaking system have high possibility of death or serious injury of the operator and the system should be improved with the introduction of additional safety devices. This thesis suggests the safety measures suitable for the roller machines with different drive systems based on the experiment results. The use of the newly developed safety system has been tested on many cases.

• Journal of Applied Reliability
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• v.17 no.4
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• pp.362-369
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• 2017

Purpose: Recently, the government of China has established new safety regulations for towing devices. The new Chinese regulation has more unfavorable conditions than the conditions of other countries. So the various measures have been reviewed to satisfy this regulation. Methods: The regulation conditions were compared through analysis of strain energy, and a method for improving the accuracy of analysis is suggested. In addition, the test method considering the tolerance is presented through tolerance analysis. This paper also explained importance of confirming the quality of products through a case of poor quality of Chinese products such as poor heat treatment. Result: We could know how strong Chinese regulations are stronger than other national laws and investigated which member receives a lot of strain energy. In order to cope with these Chinese regulations, we suggested improvement of analysis accuracy, test method through tolerance analysis, and heat treatment quality. Conclusion: This paper contributed to general counterplan of the strengthened new Chinese regulations for towing device.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Journal of Veterinary Clinics
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• v.37 no.1
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• pp.15-22
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• 2020

This study investigated the effectiveness of radiation safety rules in animal hospital and the awareness and behavior of veterinary radiation workers. With the questionnaires, the data was collected from randomly selected veterinarians in animal hospitals and animal medical imaging centers. Collected data were about radiation device, shielding device, regulations, safety management, education, knowledge, behavior and awareness. Frequency, correlation and multiple regression analysis were performed. The medical devices related with radiation in animal hospital were X-ray (59%), CT (15%), fluoroscopy (12%), mobile X-ray (12%) and others (2%). The number of people using radiation shielding device is high. The answers were low on knowing radiation related regulation and receiving radiation protection education. The group with higher knowledge and awareness shows positive correlation with safety behavior. The increase of use of the radiation related medical devices in veterinary hospital causes the increase of radiation exposure risk. This study suggests that radiation safety management system and policies need to be developed to protect radiation workers and give them correct information and consciousness.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.75
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• pp.159-177
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• 2017

In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

• Proceedings of the KSR Conference
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• 2008.06a
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• pp.659-664
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• 2008

The Railroad Safety Act's regulation reads as follows. "The Minister of Construction and Transportation may qualify and authorize the product to guarantee performance and safety of parts, machine, and device used in Railway fields." Another regulation reads as follows."“The guidelines about targets, standards, and procedures of Quality and Authority in first provision are decided as Ministry of Construction and Transportation Decree." The software used in rail cars and facilities is considered as a railway product. Therefore, it is qualified and authorized for acquiring the safety of rail cars and facilities. The software businesses shall again a Quality and Authority for applying a software to the rail cars and facilities. This paper regulates some guidelines that are needed to develop a software. The procedures that a software developer performs are divided by plan, requirement, design, implementation, and maintenance. The procedures that a software verification person performs are classified by verification plan, requirement verification, design verification, implementation verification, testing verification, maintenance verification, and safety activity. The entire processes and detailed activities to develope and verify a software are described as new guidelines.