의료기기 소프트웨어 밸리데이션

가이드라인 (민원인 안내서)

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

☞ 상기 질문에 ‘예’라고 답하신 경우 기존의 지침서ㆍ안내서의 개정을

우선적으로 고려하시기 바랍니다. 그럼에도 불구하고 동 지침서ㆍ안내
서의 제정이 필요한 경우 그 사유를 아래에 기재해 주시기 바랍니다.
(사유 : )

□ 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

게 설명하거나 식품의약품안전처의 입장을 기술한 것입니다.

본 안내서는 대외적으로 법적 효력을 가지는 것이 아니므로 본문의

기술방식(‘∼하여야 한다’ 등)에도 불구하고 민원인 여러분께서 반드시

준수하셔야 하는 사항이 아님을 알려드립니다. 또한, 본 안내서는 2007년

1월 1일 현재의 과학적ㆍ기술적 사실 및 유효한 법규를 토대로 작성되

었으므로 이후 최신 개정 법규 내용 및 구체적인 사실관계 등에 따라 달리

적용될 수 있음을 알려드립니다.

※ “민원인 안내서”란 대내외적으로 법령 또는 고시ㆍ훈령ㆍ예규 등을

알기 쉽게 풀어서 설명하거나 특정한 사안에 대하여 식품의약품안전처
의 입장을 기술하는 것(식품의약품안전처 지침서등의 관리에 관한
규정 제2조)

※ 본 안내서에 대한 의견이나 문의사항이 있을 경우 식품의약품안전처 의료기

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-

ISO/IEC 25020

ISO/IEC 25021 (SQuaRE )

ISO/IEC 25022 (ISO/IEC 9126-3 )

ISO/IEC 2502X
ISO/IEC 25023 (ISO/IEC 9126-2 )

ISO/IEC 25024 (ISO/IEC 9126-4 )

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Level

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

6.1 5.1.1 6.2

5.1.2 7.7
( )
Annex A

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7
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7.2

7.3

7.4

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8
6.2.3 7.4

8.1
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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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5.3.11.4b) 8

6.2.5

6.4
10
6.5

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11 5.4.2.1

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11.3

5.4.4.3
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730-1998 Standard for Software Quality Assurance Plans.

730.1-1995 Guide for Software Quality Assurance Planning.

828-1998 Standard for Software Configuration Management Plans.

829-1983 Standard for Software Test Documentation

830-1993 Recommended Practice for Software Requirements Specifications

982.1-1988 Standard Dictionary of Measures to Produce Reliable Software.

Guide for the Use of IEEE Standard Dictionary of Measures to

982.2-1988
Produce Reliable Software

983-1986 Guide for Software Quality Assurance Planning.

1008-1987 Standard for Software Unit Testing.

1012-1998 Standard for Software Verification and Validation.

Standard for Software Verification and Validation: Content Map to

1012a-1998
IEEE/EIA12207.1-1997

1016-1998 Recommended Practice for Software Design Descriptions.

1028-1988 Standard for Software Reviews and Audits.

1042-1987 Guide to Software Configuration Management.

Standard for Software Project Management Plans: Content Map to

1058a-1998
IEEE/EIA 12207.1-1997

1063-1987 Standard for Software User Documentation.

1074-1997 Standard for Developing Software life cycle Processes.

1228:1994 Standard for Software Safety Plans

1233-1998 Guide for Developing System Requirements Specifications.

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1. 1.

2. SCM

4. SCM 3.

4.1 3.1

4.2 SCM 3.2

4.3 SCM 3.3 SCM

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

4.3.6 / 3.5

4.4 SCM 3.2.4 SCM

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4.6 SCM 2.5 SCM

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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 -
-
-

-
-
-
V&V -
-
-
-

-
V&V -
-

V&V -

-
V&V
-

V&V -

-
V&V
-

-
V&V
-

-
-
V&V
-
-

-
-
-
V&V
- /
-
-

V&V -
 yes ‘ ‘ .

(Blood Establishment) ?

.)

‘ ’ ?

,
? .

(life supporting) ?

, (ablation generators)
?

(malfunction)
(therapy) ?

(diagnostic) ?

(intervention)
(vital signs) (alarms) ?
 ‘ ’ , yes ‘ ’
.

‘ ’ ?

,
?

(care) ?

1 2 ‘No’ , ‘ ’ .
 ( )

5.2 5.5 5.6

5.1 5.3 5.4 5.7 5.8

( )

5.2 5.5 5.6

5.1 5.3 5.4 5.7 5.8

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

ISO 14971 Yes No

Data
?

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 5.1.3 5.3.3 5.3.3.1

5.3.10 5.3.10.1
6.5.1 6.5.1.4

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

5.1.7 1:2002 F 3.15

5.1.8 6.1.1 6.1.1.1

5.1.9 6.2.1 6.2.1.1

6.8.1 6.8.1.1

7.2.2 7.2.2.1
5.1.10
7.2.3 7.2.3.1

5.1.11 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

5.2. 5.3.4 a) b)

5.2.6 5.3.4 5.3.4.2

6.4.2 6.4.2.3

5.3.5

5.3.1
5.3.5.1

5.3.5
5.3.2
5.3.5.2

5.3 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
5.4.1

5.3.6 5.3.6.1

5.4.2
 5.4.3
5.3.6.2

5.4.4 6.4.2 5.3.6.7

5.3.6
5.3.7
6.4.2

5.5.1
5.3.7 5.3.7.1

5.5 5.5.2 5.3.6 5.3.6.5

5.3.7 5.3.7.5

5.5.3
5.3.7 5.3.7.5

5.5.4 5.3.7 5.3.7.5

6.4.2 6.4.2.5

5.5.5 5.3.7 5.3.7.2

5.3.8
5.3.9
5.3.10
6.4.1
6.4.2

5.6.1 5.3.8 5.3.8.2

5.3.8 5.3.8.2
5.6.2
5.3.10 5.3.10.1

5.6 5.6.3 5.3.9 5.3.9.1

5.6.4 5.3.9.3.

5.6.5 6.4.2 6.4.2.2

5.6.6 5.3.8 5.3.8.2

5.6.7 5.3.8 5.3.8.2

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

5.7.3 6.8.1 6.8.1.1

5.7.4 6.4.2 6.4.2.2

5.3.9 5.3.9.3

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

6.2.3 5.5.2 5.5.2.1

6.2.4 5.5.2 5.5.2.5

6.2.5 5.5.3 5.5.3.1

5.5.5 5.5.5.3

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
62304 1
7
/ .
( ) .

5.5
8
6.2

6.2.2

8.1.1
6.2.2 6.2.2.1
8.1

8.1.2 SOUP

8.1.3 6.2.2 6.2.2.1

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

9.1 6.8.1 6.8.1.1 b)

6.8.2 6.8.2.1

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

9.5 6.8.1 6.8.1.1 a)

9.6 6.8.1 6.8.1.1 b)

6.8.2 6.8.2.1

9.7
6.8.1 6.8.1.1 d)

12207
9.8
 ISO 13485:2003 ‘ ’ :
?

5.1 7.3.1 Yes/No

5.2 7.3.2 Yes/No

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

8.1 7.5.3 Yes/No

8.2 7.5.3 Yes/No

8.3 Yes/No

9
Yes/No
29) (Regression analysis)
, , , , , , , ,
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, .