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IEC/ISO 62366 医療機器のユーザビリティー

IEC/ISO 62366 .. IEC/SC62A/JWG4 .. 1.. IEC 60601-1-6 . 2005 ISO .. JWG4 . 2007 1 22 25 JEITA . CDV FDIS .. 2.. 2007 7 FDIS .. 2007 9 62A/589/RVD . FDIS IS . 2007 10 IS . 3.. IEC 60601-1-6 . 2013 AM1,ED3. IEC 62366 .. 4.. 2011 9 JWG4 IEC. 62366 . TR . 2013 1 10 IEC 62366 -1 CDV . IEC 62366 -2 DTR . 5. IEC/ISO 62366 2007 .. UI .. 6.. 7.. 1 * . 2 . 3 . 4 * .. * .. * .. 8.. 5 * . * . * .. * .. 9.. 5 * . * .. * UI . * . * . 6 * . 7 * . 10.. 11.. USABILITY .. EFFECTIVENESS .. EFFICIENCY .. 12.. 13.. 14.. Application specification .. UI .. 15.. 16.. 17.. 18.. - . - - .. / .. 19.. 20.. 21.. 22.. 23.. 20 .. 24.. 25. 6.. - . - . - . - .. 26. 7.. - . - . - .. 27.. ISO14971 .. 28.. 29.. 20ml . 24 .. 71 .. 10ml .. 30.. 31.. 32.. 33.. 1 .. 34. Annex EEE .. / .. 11.

これまでの経緯 • iec 60601-1-6医用電気機器のユーザビリ ティー規格が2005年に制定、isoより、これ は医用電気機器のみならずもっと広い医療

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Transcription of IEC/ISO 62366 医療機器のユーザビリティー

1 IEC/ISO 62366 .. IEC/SC62A/JWG4 .. 1.. IEC 60601-1-6 . 2005 ISO .. JWG4 . 2007 1 22 25 JEITA . CDV FDIS .. 2.. 2007 7 FDIS .. 2007 9 62A/589/RVD . FDIS IS . 2007 10 IS . 3.. IEC 60601-1-6 . 2013 AM1,ED3. IEC 62366 .. 4.. 2011 9 JWG4 IEC. 62366 . TR . 2013 1 10 IEC 62366 -1 CDV . IEC 62366 -2 DTR . 5. IEC/ISO 62366 2007 .. UI .. 6.. 7.. 1 * . 2 . 3 . 4 * .. * .. * .. 8.. 5 * . * . * .. * .. 9.. 5 * . * .. * UI . * . * . 6 * . 7 * . 10.. 11.. USABILITY .. EFFECTIVENESS .. EFFICIENCY .. 12.. 13.. 14.. Application specification .. UI .. 15.. 16.. 17.. 18.. - . - - .. / .. 19.. 20.. 21.. 22.. 23.. 20 .. 24.. 25. 6.. - . - . - . - .. 26. 7.. - . - . - .. 27.. ISO14971 .. 28.. 29.. 20ml . 24 .. 71 .. 10ml .. 30.. 31.. 32.. 33.. 1 .. 34. Annex EEE .. / .. 11.

2 35.. ISO 14971 4.. IEC 60601-2-2.. / / .. / / .. / / . 36. OLYMPUS MEDICAL SYSTEMS.. 37.


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