Earticle

초록

영어

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.

목차

 Ⅰ. 서론
 Ⅱ. 연구방법
 Ⅲ. 연구결과
  1. 의료기기 국제표준기구 현황
  2. 의료기기 국제표준
  3. 해외 의료기기 표준기관 현황
  4. IEC/TC 62 현황
  5. IEC/TC 62의 표준제개정 현황
  6. 의료기기 국내표준화기구 현황
  7. 의료기기 표준특허 현황
 Ⅳ. 결론 및 고찰
 REFERENCES

키워드

저자

• 이태범 [ Tae-Bum Lee | 한국전기연구원 ] Corresponding author

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  보건의료산업학회지 [The Korean Journal of Health Service Management]

• 간기

  계간

• pISSN

  2093-5986

• 수록기간

  2007~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 517 DDC 613