• Journal of Biomedical Engineering Research
• /
• v.44 no.3
• /
• pp.204-210
• /
• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• Journal of Applied Reliability
• /
• v.5 no.2
• /
• pp.209-219
• /
• 2005

The required standards for environmental tests for communication and electronic equipment used currently are not standards into which the Korean climate and use environment are taken into consideration. But the most used environmental testing standards of the U.S. army(MIL-STD-810) has been used without taking into consideration the Korean domestic situation and conditions by simply translating the US standards. Adherence to these standards may increase in the manufacturing costs according to excessively strict standards. Therefore, this paper will propose a new environmental test standards for temperature.

• Korean Journal of Construction Engineering and Management
• /
• v.2 no.4 s.8
• /
• pp.107-116
• /
• 2001

As the international trade has been increased, unified worldwide standards are getting more important and necessary. At the TBT(Agreement on Technical Barrier to Trade) of WTO(World Trade Organization) and the CTI meeting of APEC(Asia-Pacific Economic Cooperation), they made an agreement with applying International Standards to National Standards gradually. In addition, ISO (International Organization for Standardization) established the ISO/IEC Guide 21, a guideline for applying International Standards to National Standards. In these environment, Korean Industrial Standards has to be prepared for it. This paper introduce the comparison between Korean Industrial Standards and ISO Standards about the standards of sampling and testing the fresh concrete, based on ISO/IEC Guide 21 by ISO and the Applying guideline by Korean Agency for Technology and Standards, and then discuss the problem about applying them. The overall objective is to establish the applying guideline on construction fields, which is civil and building engineering part(KS F) of Korean Industrial Standards.

• Proceedings of the Korean Magnestics Society Conference
• /
• 2008.12a
• /
• pp.245.1-245.1
• /
• 2008

• Journal of the Korea Safety Management & Science
• /
• v.11 no.2
• /
• pp.167-178
• /
• 2009

De facto standards can be divided into the U.S. group standards' and 'forum and the consortium standard. mainly applies to high-tech industry forums, and a consortium standard of the industry given the nature of the standard are frequently revised, the country Due to the introduction of standard time. Economic loss to consider when in reality, the introduction of national standards of the United States is limited to the desirable standard, and the fact the actual award of standards, national standards, or if you want to introduce standard, each of depending on the type of attitude and strategy for standards by category, based on the characteristics of each body strategy and are needed. Through this study on utilization of de facto standards for national standards, it is researched that major de facto standards bodies status and domestic industrial fields which need utilization of de facto standards for national standards. Through overseas Case, effective usage of de facto standards will be obtained.

• The Journal of Korean Medicine
• /
• v.27 no.3 s.67
• /
• pp.222-226
• /
• 2006

Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use. Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.

• Proceedings of the Korean Geotechical Society Conference
• /
• 2008.10a
• /
• pp.247-258
• /
• 2008

Environmental standards for beneficial uses of dredged materials are proposed. Even though chemical analysis of ocean sediments are carried out frequently, their analyses results were not interrelated with the effects of biological lives due to a shortage of biological data. These facts have resulted in difficulty to develope Korean's standards of recycling dredged materials. This paper first searched existing current foreign standards, analyzed local contaminated ocean sediment data, identified their main chemical components of contaminants, and then compared with clean-up standards of sediments consisting of lower and higher levels. From these analysis, new environmental standards considering Korean domestic circumstances are proposed. It is judged that new standards are appropriate to both Korean national sedimental environments and economically recycling aspects because environmental standard levels proposed are higher than background levels of sediments in Korean and foreign standards.

• The Monthly Technology and Standards
• /
• s.49
• /
• pp.112-113
• /
• 2006

• The Monthly Technology and Standards
• /
• s.49
• /
• pp.123-126
• /
• 2006

• The Monthly Technology and Standards
• /
• s.49
• /
• pp.78-87
• /
• 2006