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제 출 문식품의약품안전청장귀 하이 보고서를 “의료기기 품목별 적용규격 현황조사 및 DB구축(한국산업기술시험원/김정수)”과제의 연구결과보고서로 제출합니다.2007. 11.주관연구기관명 : 한국산업기술시험원주관연구책임자 : 김 정 수
목차Ⅰ. 연구개발결과 요약문(한글) ························································································································ 1(영문) ························································································································ 2Ⅱ. 연구개발과제 연구결과제1장 연구개발과제의 최종 연구개발 목표 ······················································ 5제2장 연구개발과제의 최종 연구개발 내용 및 방법 ······································ 9제3장 연구개발과제의 최종 연구개발 결과 ······················································ 11제4장 연구개발과제의 연구결과 고찰 및 결론 ················································ 93제5장 연구개발과제의 연구성과 ·········································································· 94제6장 기타 중요변경사항 ······················································································ 96제7장 참고문헌 ········································································································ 97제8장 첨부서류 ········································································································ 98총괄연구과제요약 ············································································································ 99별첨 1: ISO 규격 목록별첨 2: IEC 규격 목록별첨 3: EN 규격 목록별첨 4: JIS 규격 목록별첨 5: AAMI 규격 목록별첨 6: ASTM 규격 목록별첨 7: NEMA 규격 목록별첨 8: KS 규격 목록별첨 9: 키워드 목록별첨 10: 품목별 국제규격 엑셀 DB별첨 11: 국제규격(ISO/IEC) 엑셀 DB별첨 12: 다빈도 품목 규격 목록별첨 13: FDA 인정 국제규격 목록
Page 1 and 2: 〔별지 제15호 서식〕관리
Page 3: 주의1. 이 보고서는 식품의
Page 7 and 8: 주관연구책임자 의견연구
Page 9 and 10: Opinion of Project ManagerScopeStud
Page 11 and 12: 1.2 연구목적의료기기의 안
Page 13 and 14: 국외: 관련현황 없음국내:
Page 15 and 16: 적용규격: 규격명이 관련
Page 17 and 18: 국제표준화기구: Internationa
Page 19 and 20: ISO의 운영은 주요임원 및 1
Page 21 and 22: 항에 대한 결정.- ISO를 대
Page 23 and 24: 멤버십ISO 및 IEC의 TMB 의장
Page 25 and 26: 표2잠재적 (예비 또는 제안
Page 27 and 28: 단계에서, P 회원의 투표의
Page 29 and 30: 그림2규격작성의 과정 및
Page 31 and 32: 설립되고, 1914년에 첫 IEC
Page 33 and 34: 또한 회원은 전문가를 포
Page 35 and 36: 또한 과거 3년마다 ISO와 합
Page 37 and 38: (1) IEC의 안전에 관한 규격
Page 39 and 40: ● 섹터보드는 기술관리위
Page 41 and 42: 의 연장이 기술관리위원회
Page 43 and 44: 예산 및 연차회계보고서를
Page 45 and 46: 각 TC 또는 SC의 간사국(Secre
Page 47 and 48: 1.2.3.5 규격 작성의 플로차
Page 49 and 50: 1.2.3.6 IEC 규격의 제정, 개
Page 51 and 52: 인터넌스 팀의 멤버 수가
Page 53 and 54: 지지하는 2명의 회원이 필
Page 55 and 56:
CENELEC (유럽전기표준화위
Page 57 and 58:
관에 규격을 제공한다. 국
Page 59 and 60:
(TC), 분과위원회 (SC), 기술
Page 61 and 62:
DIN EN ISO + 번호: ISO와 동일
Page 63 and 64:
● ANSI 국제포럼(ANSI Internat
Page 65 and 66:
부기관, 소비자 그룹 및 기
Page 67 and 68:
집행규격위원회는 기존 규
Page 69 and 70:
2 정합화가 필요하다고 판
Page 71 and 72:
토한다.(4) BSR의 승인을 받
Page 73 and 74:
가. 규격번호 지정미국국
Page 75 and 76:
ANSI 승인을 취소할 의지가
Page 77 and 78:
- MEDICAL AND SURGICAL MATERIALS AN
Page 79 and 80:
래에 검토결과 일부를 예
Page 81 and 82:
3 CEN EN 376 20024 CEN EN 455-1 200
Page 83 and 84:
33 JIS T 0601-2-34 2005의용 전
Page 85 and 86:
14 F1855-00(2005)15 F1876-98(2003)e
Page 87 and 88:
3 KS P 1003 2006 복지관련기기
Page 89 and 90:
24 A04070의료용화학소독기st
Page 91 and 92:
2.3 의료기기 공통적용 국
Page 93 and 94:
- 참조규격AAMI EN BSI DIN JIS
Page 95 and 96:
46 A11120 치과진단용엑스선
Page 97 and 98:
11 IEC12 IEC13 IEC14 IEC15 IEC16 IE
Page 99 and 100:
제5장 연구개발과제의 연
Page 101 and 102:
제6장 기타 중요변경사항
Page 103 and 104:
제8장 첨부서류해당없음98
Page 105 and 106:
○ 연구내용 (1000~1200자)본
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