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의료기기 소프트웨어 밸리데이션 가이드라인
의료기기 소프트웨어 밸리데이션 가이드라인
2007. 1.
의료기기본부
의료기기품질팀
지침서ᆞ안내서 제ᆞ개정 점검표
명칭 의료기기 소프트웨어 밸리데이션 가이드라인 (민원인 안내서)
아래에 해당하는 사항에 체크하여 주시기 바랍니다.
□ 이미 등록된 지침서ㆍ안내서 중 동일ㆍ유사한 □ 예
내용의 지침서ㆍ안내서가 있습니까? ☑ 아니오
□ 법령(법ㆍ시행령ㆍ시행규칙) 또는 행정규칙(고시ㆍ훈령ㆍ □ 예
예규)의 내용을 단순 편집 또는 나열한 것입니까? ☑ 아니오
등록대상
□ 예
여부 □ 단순한 사실을 대외적으로 알리는 공고의 내용입니까?
☑ 아니오
□ 1년 이내 한시적 적용 또는 일회성 지시ㆍ명령에 □ 예
해당하는 내용입니까? ☑ 아니오
□ 예
□ 외국 규정을 번역하거나 설명하는 내용입니까?
☑ 아니오
□ 신규 직원 교육을 위해 법령 또는 행정규칙을 알기 □ 예
쉽게 정리한 자료입니까? ☑ 아니오
☞ 상기 사항 중 어느 하나라도 ‘예’에 해당되는 경우에 지침서ㆍ안내서 등록 대상이
아닙니다.
지침서ㆍ안내서 제ㆍ개정 절차를 적용하실 필요는 없습니다.
□ 내부적으로 행정사무의 통일을 기하기 위하여 반복적으로
□ 예(☞지침서)
행정사무의 세부기준이나 절차를 제시하는 것입니까?
☑ 아니오
지침서ㆍ안 (공무원용)
내서 구분 □ 대내외적으로 법령 또는 고시ㆍ훈령ㆍ예규 등을 알기 쉽게
☑ 예(안내서)
풀어서 설명하거나 특정한 사안에 대하여 식품의약품안전처
□ 아니오
의 입장을 기술하는 것입니까? (민원인용)
□ 상위 법령을 일탈하여 새로운 규제를
□ 예
신설ㆍ강화하거나 민원인을 구속하는 내용이
기타 확 ☑ 아니오
있습니까?
인사항 ☞ 상기 질문에 ‘예’라고 답하신 경우 상위법령 일탈 내용을 삭제하시고
지침서ㆍ안내서 제ㆍ개정 절차를 진행하시기 바랍니다.
상기 사항에 대하여 확인하였음.
2016 년 5 월 31 일
담당자
확 인 (부서장) 유 희 상
이 안내서는 의료기기 소프트웨어 밸리데이션에 대하여 알기 쉽
---------------------------- ----------------------------
2005-69 2005-69
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9 FDIS , ISO/TC 210, ISO/IEC JTC 1/SC 7, CENELEC TC 62
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,
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5.3
6.1
6.2
5 6.4
6.5
6.8
7.1
5.3.1
5.3.3
5.3.7
5.3.8
5.3.9
5.3.10
6.1.1
6.2.1
6.2.2
6.4.1
6.5.1
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7.2.3
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5.1.1
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7.2.2 7.2.2.1
5.1.10
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6.2.2 6.2.2.1
(item)
5.3.3
5.3.4
6.4.2
5.2.1
5.3.3 5.3.3.1
5.2.2
5.2
5.3.4 5.3.4.1
5.2.3
5.2.4
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5.3.5
5.3
5.3.1
5.3.5 5.3.5.1
5.3.2
5.3.5.2
5.3.3 SOUP
5.3.4 SOUP
5.3.5
5.3.6
5.3.5 5.3.5.6
5.3.6
6.4.2
5.4.1
5.3.6.1
5.4
5.4.2 5.3.6
5.4.3
5.3.6.2
5.3.6
5.3.7
6.4.2
5.5.1
5.3.7 5.3.7.1
5.5.3
5.3.7 5.3.7.5
5.6 5.3.8
5.3.9
5.3.10
6.4.1
6.4.2
5.3.8 5.3.8.2
5.6.2
5.3.10 5.3.10.1
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5.6.8
6.4.1 6.4.1.6
5.3.8
5.3.9
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5.7.1
5.3.8 5.3.8.4
5.3.9 5.3.9.1
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(ensure)
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6.2.1
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5.5.1.1
5.5.1
6.2.1.2 5.5.1.2
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6.2.1.3 5.5.2.2
5.5.2
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12207
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.
Is used by Is used by
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Stakeholder Developer
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Quality Metrics
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9126-2n(2501x)
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-
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5
23) Roger's S Pressman, Software Engineering; :A Practitioner's Approach, 3rd Edition(1995)
ISO/IEC TR 15846 ISO/IEC 12207:1995 ISO 10007:1995
6.2.1 5
SCM
6 6
6.1
5.1.2 7.7
( )
Annex A
5.1.3
5.1.4
6.2
5.2.4
6.2.1
7.1.2.1 e)
7.2
7.3
6.8
6.3
7.1.3
7.4
SCM
6.4 7.3
6.5 7.1.5
6.2.2 5.2
7
(SCIs) 7.2
7.2
7.3
7.4
5.3.1.2 b) 5.3
8
6.2.3 7.4
8.1
ISO/IEC TR 15846 ISO/IEC 12207:1995 ISO 10007:1995
8.2
8.3
8.4 7.3
8.5
6.2.4 5.4
9
7.5
9.1
9.2
9.3
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5.3.4.3 7.6
5.3.9.5 b)
5.3.11.4b) 8
6.2.5
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10
6.5
6.6.1.1
6.6.3.1 c)
6.7.1.1
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7.3
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11.2 5.5.6.1 b)
11.3
5.4.4.3
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4.1 3.1
4.3.1 3.3.1
4.3.2 3.3.2
4.3.3 3.3.3
4.3.4 3.3.4
4.3.5 3.2.3
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6. 2.5 SCM
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(Moderate) 2
.
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V&V ( )
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4.2
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4.4
4.5
4.6 , ,
5. V&V
5.1 :
5.1.1 : V&V
5.2 :
5.2.1 : V&V
5.3 :
5.3.1 : V&V
5.4 :
5.4.1 : V&V
5.4.2 : V&V
5.4.3 : V&V
5.4.4 : V&V
5.4.5 : V&V
5.4.6 : V&V
5.5 :
5.5.1 : V&V
5.6 :
5.6.1 : V&V
6. V&V
7. V&V
7.1
7.2
7.3
7.4
7.5 , ,
8. V&V
26)
IEEE Std 12207
1012 V&V
-
- ( )
V&V -
-
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-
-
-
V&V -
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-
-
-
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.
‘ ’ ?
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6.3
9
A B C
4 x x x
5.1 5.1.1, 5.1.2, 5.1.3, 5.1.6, 5.1.7, 5.1.8, 5.1.9 x x x
5.1.5, 5.1.10, 5.1.11 x x
5.1.4 x
5.2 5.2.1, 5.2.2, 5.2.4, 5.2.5, 5.2.6 x x x
5.2.3 x x
5.3 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.6 x x
5.3.5 x
5.4 5.4.1 x x
5.4.2, 5.4.3, 5.4.4 x
5.5 5.5.1 x x x
5.5.2, 5.5.3, 5.5.5 x x
5.5.4 x
5.6 x x
5.7 x x
5.8 5.8.4, x x x
5.8.1, 5.8.2, 5.8.3, 5.8.5, 5.8.6, 5.8.7, 5.8.8 x x
6.1 6.1 x x x
6.2 6.2.1, 6.2.2, 6.2.4, 6.2.5 x x x
6.2.3 x x
6.3 x x x
7.1 x x
7.2 x x
7.3 x x
7.4 7.4.1 x x x
7.4.2, 7.4.3 x x
8 x x x
9 x x x
/
( C)
X Y
( A) ( C)
W Z
( B) ( C)
ISO 14971
IEC 60601-1,
ISO 13485
IEC 61010-1
IEC 62304
S/W
IEC/ISO 12207,
IEC 61508-3,
IEC/ISO 90003
,
IEC 60601-1-4:1996 1:1999
IEC 62304
PEMS
6.8
6.8.210 4.2 4.3 c)
52.201
52.201.1 4.1
52.201.2 4.1 4.2
52.201.3 4.2
52.202
52.202.1 4.2
52.202.2 5.1.1, 5.1.5
52.202.3 4.1, 5.1.1 g
52.203
52.203.1 5.1.1
52.203.2 5.1.1
52.203.3
52.203.4 5.1.7
52.203.5 7
52.204
52.204.1 4.2
52.204.2 4.2, 7
52.204.3
52.204.3.1
52.204.3.1.1 4.2, 7.1
52.204.3.1.2 4.2, 7.1.2
52.204.3.1.3 4.2
52.204.3.1.4 4.2, 7.1.2 e)
52.204.3.1.5 4.2, 7.1.2
52.204.3.1.6 4.2, 7.1
52.204.3.1.7 4.2
52.204.3.1.8 4.2
52.204.3.1.9 4.2
52.204.3.1.10 4.2
52.204.3.2
52.204.3.2.1 4.2
52.204.3.2.2 4.2, 4.3
52.204.3.2.3
52.204.3.2.4
52.204.3.2.5 4.2
52.204.4
52.204.4.1 4.2
52.204.4.2 4.2
52.204.4.3 4.2
52.204.4.4 4.2
52.204.4.5
52.204.4.6 4.2
52.205 4.1
52.206
52.206.1 5.2
52.206.2 7.2.2
52.206.3
52.207
52.207.1 5.3.1
52.207.2 5.3
52.207.3
52.207.4
52.207.5
52.208
52.208.1 5
52.208.2
52.209
52.209.1 5.7.1
52.209.2 5.1.5, 5.1.6
52.209.3 5.2.6, 5.3.6, 5.4.4, 5.5.5, 5.6, 5.7
52.209.4
52.210
52.210.1 4.1
52.210.2 4.1
52.210.3 4.1
52.210.4
52.210.5
52.210.6
52.210.7
52.211
52.211.1 6
52.211.2 4.1, 6
52.212
52.212.1 4.1
Data
Yes
No
No
Data
?
Yes
Data
Data Yes
(are
? detected)
(ensure)
No
IEC 62304
ISO/IEC 62304 ISO/IEC 12207
5.3
6.1
6.2
5 6.4
6.5
6.8
7.1
5.3.1
5.3.3
5.3.7
5.3.8
5.3.9
5.3.10
6.1.1
6.2.1
6.2.2
6.4.1
6.5.1
6.8.1
7.1.2
7.1.3
7.2.2
7.2.3
5.3.1.1
5.3.1 5.3.1.3
5.1.1
7.1.2 5.3.1.4
7.1.2.1
5.1.2
7.1.3 7.1.3.3
5.1.4 , 5.3.1.3
5.3.1
5.3.1.4
5.1.5
5.3.8 5.3.8.1
6.4.1.4
6.4.1
6.4.1.5
5.3.7
5.1.6 5.3.7.5
5.3.8
5.3.8.5
5.3.9
5.3.9.3
7.2.2 7.2.2.1
5.1.10
7.2.3 7.2.3.1
5.3.3
5.3.4
6.4.2
5.2.1
5.3.3 5.3.3.1
5.2.2
5.2
5.3.4 5.3.4.1
5.2.3
5.2.4
5.2. 5.3.4 a) b)
5.3.5
5.3.1
5.3.5.1
5.3.5
5.3.2
5.3.5.2
5.3.4 SOUP
5.3.5
5.3.6
5.3.5 5.3.5.6
5.3.6
6.4.2
5.4
5.4.1
5.3.6 5.3.6.1
5.4.2
5.4.3
5.3.6.2
5.3.6
5.3.7
6.4.2
5.5.1
5.3.7 5.3.7.1
5.5.3
5.3.7 5.3.7.5
5.3.8
5.3.9
5.3.10
6.4.1
6.4.2
5.3.8 5.3.8.2
5.6.2
5.3.10 5.3.10.1
5.6.4 5.3.9.3.
5.6.8
6.4.1 6.4.1.6
5.3.8
5.7 5.3.9
6.4.1
6.4.2
6.8.1
5.7.1
5.3.8 5.3.8.4
5.3.9 5.3.9.1
5.7.2
6.4.1 6.4.1.6
5.7.5
5.3.9 5.3.9.1
5.3.9
5.4.2
6.2.5
6.2.6
5.4.2.1
5.8.1 5.4.2
5.4.2.2
(ensure) 6.2.6
6.2.6.1
5.8.2 (known)
6.2.5 6.2.5.1
5.3.9 5.3.9.3
5.8.3 (known)
5.8
5.8.4
5.8.5
5.8.6
6.2.6 6.2.6.1
(ensure)
5.8.7
5.8.8
5.5
6
6.2
6.1
5.5.1 5.5.1.1
6.2 5.5.1
5.5.2
5.5.3
5.5.5 ( )
6.2.1
6.2.1.1
5.5.1.1
5.5.1
6.2.1.2 5.5.1.2
5.5.2.1
6.2.1.3 5.5.2.2
5.5.2
5.5.2.3
5.5.2.4
6.2.2
5.5.1 5.5.1.2
5.5.3
6.3
6.2.6
6.3.1
5.5.3 5.5.3.2
6.3.2
6.2.6 6.2.6.1
1:2002 F 3. 15
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5.5
8
6.2
6.2.2
8.1.1
6.2.2 6.2.2.1
8.1
8.1.2 SOUP
5.5.3
8.2
6.2.3
8.2.1 6.2.3 6.2.3.1
5.5.3 5.5.3.2
8.2.2
6.2.3 6.2.3.1
8.2.3
6.2.3 6.2.3.1
8.2.4
8.3
6.2.4 6.2.4.1
5.5
9 6.2
6.8
6.8.2 6.8.2.1
9.2
6.8.1 6.8.1.1 b)
9.3
6.8.1 6.8.1.1 a)
9.4 6.2.3
5.5.3
9.7
6.8.1 6.8.1.1 d)
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9.8
ISO 13485:2003 ‘ ’ :
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5.3 Yes/No
5.4 Yes/No
5.5
Yes/No
5.6
Yes/No
7.3.3
5.7 Yes/No
7.3.4
7.3.5
5.8 7.3.6 Yes/No
6.1 7.3.7
Yes/No
6.2 Yes/No
7.3.5
6.3 7.3.6 Yes/No
7.1
Yes/No
7.2 Yes/No
7.3 Yes/No
7.4
Yes/No
8.3 Yes/No
9
Yes/No
29) (Regression analysis)
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