duration of re-applications
Russian translation: продолжительность случаев повторного использования/применения
| 18:21 Sep 26, 2023 |
| English to Russian translations [PRO] Medical - Medical: Instruments / surgical microscope | |||||||
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|  Selected response from: Oleg Lozinskiy Russian Federation Local time: 03:02 | ||||||
Grading comment
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| 3 +2 | продолжительность случаев повторного использования/применения |
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Answers
29 mins confidence: 
peer agreement (net): +2
peer agreement (net): +2продолжительность случаев повторного использования/применения Explanation: Если речь идет об этом: A3. Device description – typical contents The description should be detailed enough to allow for a valid evaluation of the state of compliance with Essential Requirements, the retrieval of meaningful literature data and, if applicable, the assessment of equivalence to other devices described in the scientific literature: name, models, sizes, components of the device, including software and accessories device group to which the device belongs (e.g. biological artificial aortic valve) whether the device is being developed/ undergoing initial CE-marking/ is CE-marked whether the device is currently on the market in Europe or in other countries, since when, number of devices placed on the market intended purpose of the device exact medical indications (if applicable) name of disease or condition/ clinical form, stage, severity/ symptoms or aspects to be treated, managed or diagnosed patient populations (adults / children / infants, other aspects) intended user (use by health care professional / lay person) organs / parts of the body / tissues or body fluids contacted by the device duration of use or contact with the body repeat applications, including any restrictions as to the number or duration of re- applications contact with mucosal membranes/ invasiveness/ implantation contraindications precautions required by the manufacturer single use / reusable other aspects general description of the medical device including a concise physical and chemical description the technical specifications, mechanical characteristics sterility radioactivity how the device achieves its intended purpose principles of operation materials used in the device with focus on materials coming in contact (directly or indirectly) with the patient/ user, description of body parts concerned whether it incorporates a medicinal substance (already on the market or new), animal tissues, or blood components, the purpose of the component other aspects whether the device is intended to cover medical needs that are otherwise unmet/ if there are medical alternatives to the device / if the device is equivalent to an existing device, with a description of the situation and any new features if the device is intended to enter the market based on equivalence: name, models, sizes, settings components of the device presumed to be equivalent, including software and accessories whether equivalence has already been demonstrated Intended performance, including the technical performance of the device intended by the manufacturer, the intended clinical benefits, claims regarding clinical performance and clinical safety that the manufacturer intends to use For devices based on predecessor devices: Name, models, sizes of the predecessor device, whether the predecessor device is still on the market, description of the modifications, date of the modifications. The current version number or date of the information materials supplied by the manufacturer (label, IFU, available promotional materials and accompanying documents possibly foreseen by the manufacturer). https://clinical-evaluation.report/meddeva3/?lang=en/ -------------------------------------------------- Note added at 42 мин (2023-09-26 19:04:54 GMT) -------------------------------------------------- Или об этом: 1 Medical Device Information (MEDDEV A3) ... 1.2 Intended purpose of the device, including: - exact medical indications (if applicable), contraindications - name of disease or condition/ clinical form, stage, severity/ symptoms or aspects to be treated, managed or diagnosed - patient populations (adults / children / infants, other aspects) - intended user (use by health care professional / lay person) - organs / parts of the body / tissues or body fluids contacted by the device - duration of use or contact with the body, invasiveness - repeat applications, including any restrictions as to the number or duration of re-applications - contact with mucosal membranes/ invasiveness/ implantation - single use / reusableIntended purpose of the device, including: - exact medical indications (if applicable), contraindications - name of disease or condition/ clinical form, stage, severity/ symptoms or aspects to be treated, managed or diagnosed - patient populations (adults / children / infants, other aspects) - intended user (use by health care professional / lay person) - organs / parts of the body / tissues or body fluids contacted by the device - duration of use or contact with the body, invasiveness - repeat applications, including any restrictions as to the number or duration of re-applications - contact with mucosal membranes/ invasiveness/ implantation - single use / reusable https://www.google.ru/url?sa=t&rct=j&q=&esrc=s&source=web&cd... |
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