benchtop study
Russian translation: исследование в лабораторных условиях
| 13:03 Apr 14, 2019 |
| English to Russian translations [PRO] Medical - Medical: Instruments | |||||||
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|  Selected response from: Natalie Poland Local time: 12:35 | ||||||
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| Summary of answers provided | ||||
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| 4 +2 | изучение в ходе стендовых испытаний |
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| 4 | исследование в лабораторных условиях |
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Answers
12 mins confidence: 
исследование в лабораторных условиях Explanation: Дословно "на лабораторном столе" (а не животных или пациентах). |
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Notes to answerer
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1 hr confidence: peer agreement (net): +2
peer agreement (net): +2изучение в ходе стендовых испытаний Explanation: Results for devices tested beyond 140 punctures http://stm-journal.ru/ru/numbers/2018/2/1429/html https://www.fda.gov/downloads/MedicalDevices/NewsEvents/Work... Traditional Feasibility Study • Sample size typically 20 to 30 • Bench testing: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/7610... Benchtop Puncture Study to be used with Brineura along with the Administration Kit based on clinical and bench top validation/verification testing Puncture Study Response for Brineura We acknowledge your responses to our latest information request regarding the benchtop study protocol you provided. Judging from your response we would recommend that you incorporate a method of assessing the degradation of the septum material over time as you puncture the septum (e.g. scanning electron microscopy analysis for surface porosity, holes, roughness, cracks, peeling, etc.). The Agency would be open to inclusion of measuring septum surface defects after discrete simulated time points throughout the study (e.g. after each subsequent simulated year of punctures) to determine when and if the surface material of the septum begins to deteriorate. |
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Notes to answerer
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