ヘルスソフトウェア開発ガイドライン GHS 開発ガイドライン）

1 GHS Ver. Ver. 2/60 Ver. ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 Ver. 3/60 1 .. 6 .. 6 .. 6 .. 6 2 .. 7 3 .. 12 .. 12 .. 12 .. 12 .. 12 .. 13 .. 13 .. 13 .. 14 .. 14 .. 14 .. 17 .. 17 .. 18 .. 18 .. 18.

2 18 .. 19 .. 20 .. 20 .. 20 .. 20 .. 21 .. 21 .. 21 .. 22 .. 22 .. 22 4 .. 24 .. 24 .. 24 .. 24 .. 24 Ver. 4/60 .. 25 .. 25 .. 25 .. 26 .. 26 .. 26 .. 26 .. 27 .. 27 .. 27.

3 28 .. 29 .. 29 .. 29 .. 29 .. 29 .. 29 .. 29 .. 30 .. 30 .. 30 .. 30 .. 30 .. 30 .. 30 .. 31 .. 31 .. 31 .. 31 .. 31 .. 31 .. 31 .. 31 .. 31 .. 32 .. 32 .. 32 .. 32 5.

4 33 .. 33 Ver. 5/60 .. 33 .. 33 .. 33 .. 33 .. 33 .. 34 .. 34 .. 34 .. 34 .. 34 .. 34 .. 34 .. 34 .. 35 6 .. 37 .. 37 .. 37 .. 37 .. 37 .. 38 Annex A .. 39 Annex B .. 44 Ver. 6/60 1 1 2 3

5 3 6 1. ISO 9001:2008 (JIS Q 9001:2008) ISO 9001:2015 (JIS Q 9001:2015) 2. ISO 14971:2007 (JIS T 14971:2012) 3.

6 IEC 62304:2006 (JIS T 2304:2012) 4. IEC 82304-1 CD Health Software Part 1: General requirements for product safety 1 2 IEC 82304-1 2016 GHS IEC 82304-1 CD Committee Draft Ver. 7/60 3 ISO 9001:2008 ISO 9001:2015 2018 9 14 JIS Q 9001:2008 2018 11 19 2 activity [ JIS T 2304:2012 ] anomaly [ JIS T 2304:2012 ] architecture [ JIS T 2304:2012 ] change request [ JIS T 2304:2012 ] configuration item (entity) [ JIS T 2304.]

7 2012 ] harm [ JIS T 14971:2012 ] hazard [ JIS T 14971:2012 ] Ver. 8/60 hazardous situation [ JIS T 14971:2012 ] health software [ IEC 82304-1 CD ] health software development organization / [ JIS T 14971:2012 ] health software user [ IEC82304-1 CD ] intended use/intended purpose [ JIS T 14971:2012 ] life-cycle [ JIS T 14971:2012 ] post-production [ JIS T 14971:2012 ] process Ver.

8 9/60 [ JIS T 2304:2012 ] responsibility organization [ IEC82304-1 ] residual risk [ JIS T 14971:2012 ] risk [ JIS T 14971:2012 , JIS T 2304:2012 ] risk analysis [ JIS T 14971:2012 ] risk assessment [ JIS T 14971:2012 ] risk control [ JIS T 14971:2012 , JIS T 2304:2012 ] risk estimation [ JIS T 14971:2012 ] Ver.

9 10/60 risk evaluation [ JIS T 14971:2012 ] risk management [ JIS T 14971:2012 , JIS T 2304:2012 ] risk analysis table G ISO 14971 JIS T 14971 risk management file safety [ JIS T 14971:2012 , JIS T 2304:2012 ] severity [ JIS T 14971:2012 ] software system [ JIS T 2304:2012 ] software unit [ JIS T 2304:2012 ] Ver.

10 11/60 task [ JIS T 2304:2012 ] traceability [ JIS T 2304:2012 ] usability [ IEC 62366:2007 ] verification 1 2 [ JIS T 2304:2012 , JIS T 14971:2012 ] validation 1 2 [ JIS T 9000:2006 ] G version Ver.