４－６. 全体的なリスク／効用分析すべてのリスクは許容可能なレベルに

４－６. 全体的なリスク／効用分析
すべてのリスクは許容可能なレベルに低減されている。本品に苦情が発生していないこと、類似医療機器の苦情分析で新たに大きなリスクが発生していないことから、臨床的有効性がリスクを上回っている。

４－７. 結論
Unit Doseを追加に関するリスク評価を行い問題ないことを確認した。苦情情報の分析、臨床評価の実施によって、リスク評価を行い問題ないことを確認した。

結果 (英語) 1:

4-6. Overall risks and benefits analysis
all risks have been reduced to an acceptable level. From that product not an complaints, complaint analysis of similar medical equipment not experiencing new big risk that exceeds the risk clinical effectiveness.

4-7. Conclusion
verified to conduct risk assessment of the additional Unit Dose, no problem. Verify complaint information analysis, clinical evaluation conducted by risk assessment, not a problem.

結果 (英語) 2:

Risk / utility analysis 4-6. Overall
risk of all is reduced to an acceptable level. The complaints do not occur in the product, since the greater risk is not generated new complaint analysis similar medical devices, clinical efficacy is higher than the risk. 4-7. Conclusion it was confirmed that there is no problem perform the risk assessment on adding the Unit Dose. Analysis of complaint information, by the practice of the clinical evaluation, it was confirmed that there is no problem perform risk assessment.

結果 (英語) 3:

4. 6. The overall risk reduction in the level of acceptable risk utility analysis at all In this article the complaint does not occur, it is not a big risk in medical equipment, the analysis of similar complaints to the clinical effectiveness of risk At 4 -- 7 performs additional risk assessment conclusions at the Unit Dose confirmed that there is no problem Complaint information analysis and evaluation, risk assessment, it was confirmed that no problem At