• The Journal of the Convergence on Culture Technology
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• v.8 no.5
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• pp.29-37
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• 2022

MDR, a new European medical device regulation newly enacted in 2017, requires that medical device products that have received CE conformity certification through MDD be re-certified by May 2024 in line with the new CE MDR regulation. The new MDR requires more stringent medical device clinical evaluation and clinical investigation than the previous MDD required, and also require the submission of documented post-marketing surveillance data. Korean medical device makers also need to meet the new MDR requirements and obtain conformity certification, but the industry is still confused because they do not understand the new regulations thoroughly. In this study, medical device regulations in Korea, the United States, and Europe are compared, and the European MDR is further compared with the previous European Medical Device Directive MDD to help understand the requirements of the new European Medical Device Act.

• The Proceeding of the Korean Institute of Electromagnetic Engineering and Science
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• v.7 no.1
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• pp.4-13
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• 1996

미국 연방통신위원회(FCC)에서는 1996. 5. 14일 부로 Digital Device에 대한 인증제도를 자기입증방식(DoC)으로 변경한다는 방침을 확정, 발표하였다(FCC 96-206, ET Docket No. 95-19, Report and Order). 이 새로운 자기입증제도는 기존 FCC의 타율규제방식(Certification, Verification, Notification등) 을 탈피하여 제조자 자율에 의한 인증개념을 도입한 것으로서, 어떤 제품(Digital Device에 대해서 FCC가 정한 기술기준에 의거 시험하여 합격하였을 경우, 제조자(인증권자) 스스로 적합선언서 (DoC : Declaration of Conformity)를 채택하고 해당 제품에 인증마크를 부착하여 출하시킨다는 것으로 기존 EU의 CE-Mark 인증제도 중 Module A와 유사한 제도이다. FCC는 이와 같은 제도변경을 위해서 1995년 2월에 이미 기본방침을 발표하여 그동안 관련업계 의 광범위한 의견수렴을 거쳤으며, 필요한 법적보완사항을 위해서 일부 통신법을 개정, 완료하였 고(1996 통신법 403(f), 상무성, NIST 등 관계기관과의 의견조정을 마친 후 본 시행안을 확정, 공표 하였다.

• Textile Coloration and Finishing
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• v.26 no.2
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• pp.106-113
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• 2014

Work-related falls are a major problem in the construction and roofing industries. To avoid serious injury to the worker caused by high decelerations or forces, different systems to absorb the energy of a fall are implemented in personal protective equipment. In this study, shock energy absorber lanyard protection tube was prepared using high tenacity PET fiber, P-aramid fiber, and UHMWPE fiber, respectively. Dynamic load test and static load test, bursting strength test based on the Korea fall protection equipment standard(Korea Occupational Safety & Health Agency standard 2013-13) or conformity European safety test(CE : EN355) were conducted. Especially maximum arrest force by dynamic load test of energy absorber showed below 6,000N.

• The Journal of the Convergence on Culture Technology
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• v.9 no.2
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• pp.525-531
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• 2023

In Korea, which is entering a super-aged society, the number of elderly patients who have difficulty walking independently is expected to increase rapidly, and it is necessary to develop wheelchair products with various functions to improve the quality of life of people with walking disabilities. Recently, wheelchair power assist devices that provide propulsion power by being attached to a manual wheelchair has been developed and is entering the domestic and global markets. In this study, we compared and analyzed the process of obtaining medical device certification for wheelchair power assist devices in Korea, the United States, and Europe. In Korea, a Class 2 medical device certification process was developed in 2021, and in the US FDA, it corresponds to Class 2 like the existing electric wheelchair and must pass the 510k certification process. In the case of Europe, it is uniquely regulated as Class I, and the CE mark can be attached through a relatively easy self-declaration of conformity. The Korean medical device industry, which is struggling with MDR certification, a new European medical device regulation, should pay attention to the relatively easy entry into the global market for wheelchair power assist products.

• Restorative Dentistry and Endodontics
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• v.39 no.1
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• pp.7-11
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• 2014

Objectives: The aim of this study was to compare the dimensional standard of several nickel-titanium (Ni-Ti) rotary files and verify the size conformity. Materials and Methods: ProFile (Dentsply Maillefer), RaCe (FKG Dentaire), and TF file (SybronEndo) #25 with a 0.04 and 0.06 taper were investigated, with 10 in each group for a total of 60 files. Digital images of Ni-Ti files were captured under light microscope (SZX16, Olympus) at $32{\times}$. Taper and diameter at $D_1$ to $D_{16}$ of each files were calculated digitally with AnalySIS TS Materials (OLYMPUS Soft Imaging Solutions). Differences in taper, the diameter of each level ($D_1$ to $D_{16}$) at 1 mm interval from (ANSI/ADA) specification No. 101 were statistically analyzed using one-way ANOVA and Scheffe's post-hoc test at 95% confidence level. Results: TF was the only group not conform to the nominal taper in both tapers (p < 0.05). All groups except 0.06 taper ProFile showed significant difference from the nominal diameter (p < 0.05). Conclusions: Actual size of Ni-Ti file, especially TF, was different from the manufacturer's statements.