14:33 Nov 28, 2016 |
German to English translations [PRO] Medical - Medical: Instruments / Checklist for features of medical devices | |||||||
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| Selected response from: Johanna Timm, PhD Canada Local time: 23:14 | ||||||
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Summary of answers provided | ||||
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3 +5 | energy |
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Discussion entries: 5 | |
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energy Explanation: "Is energy delivered to or extracted from the patient?" http://what-when-how.com/Tutorial/topic-45u19/Medical-Device... (seems to refer to DNI ISO14971) -------------------------------------------------- Note added at 5 hrs (2016-11-28 20:21:05 GMT) -------------------------------------------------- another example: How to start the analysis: Questions to Ask (ISO 14971 Annex C) ▪ Intended use? ▪ Will the device be implanted? ▪ Will device be in contact with patient or other people? ▪ Is energy delivered or extracted from the patient? ▪ Is a substance delivered or extracted from the patient? ▪ Are biological materials processed by device for subsequent re-use? ▪ How is the device sterilized? ▪ Will device be routinely cleaned? http://www.securebme.com/pdf/braddon_sbme_risk_assessment_pr... |
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