sound output limitation of CE
Russian translation: см.
| 19:22 Dec 8, 2021 |
| English to Russian translations [PRO] Tech/Engineering - Medical: Instruments | |||||
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|  Selected response from: Mikhail Zavidin Local time: 17:51 | ||||
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| 3 +1 | см. |
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27 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1| sound output limitation of ce см. Explanation: ограничение акустической мощности, установленное в соответствии с рекомендациями странам Европейского Сообщества/маркировкой CE "" is the abbreviation of "conformité européenne" (French for "European conformity") https://en.wikipedia.org/wiki/CE_marking Маркировка CE (аббревиатура фр. Conformité Européenne — «европейское соответствие») — специальный знак, наносимый на изделие, который удостоверяет, что изделие соответствует основным требованиям директив ЕС и гармонизированным стандартам Европейского союза, а также то, что продукт прошёл процедуру оценки соответствия директивам. Маркировка CE указывает на то, что изделие не является вредным (опасным) для здоровья его потребителей, а также безвредно для окружающей среды. Однако следует учитывать, что знак CE не является символом качества продукции. Решение 768/2008/EC (DECISION No 768/2008/EC), принятое 9 июля 2008 года, регулирует права и обязанности по применению маркировки СЕ (CE Mark). Согласно данному Решению Европейского Парламента, существуют рекомендации странам Европейского союза по контролю над внутренним рынком ЕС по обороту продукции, подлежащей обязательной маркировке знаком СЕ. https://ru.wikipedia.org/wiki/CE_(знак) |
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Reference comments
5 hrs |
| Reference Reference information: https://www.birpublications.org/pb/assets/raw/Books/SUoU_3rd... 10.4. European Medical Devices Directive A CE mark on a device means that the device satisfies the requirements essential for it to be fi t for its intended purpose. The MDD does not give any guidance specifi c to ultrasound emissions. The general statements of Clause 11 (on protection against radiation) and of Clause 12 (on equipment with an energy source) may be taken to apply, however. These require that “Devices shall be designed and manufactured in such a way that exposure to patients . . . shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specifi ed levels for therapeutic or diagnostic purposes”. -------------------------------------------------- Note added at 6 hrs (2021-12-09 01:42:05 GMT) -------------------------------------------------- https://mindraynorthamerica.com/cmsAdmin/uploads/h-046-00063... 23.4.1 Basic Knowledge of MI and TI The relationship of various ultrasound output parameters (frequency, acoustic pressure and intensity, etc) to bioeffects is not fully understood presently. It is recognized that two fundamental mechanisms may induce bioeffects. One is a thermal bioeffect with tissue absorption of ultrasound, and another one is a mechanical bioeffect based on cavitations. Thermal Index (TI) gives the relative index of temperature increase by thermal bioeffect, and Mechanical Index (MI) gives the relative index of mechanical bioeffect. TI and MI indices reflect instantaneous output conditions, so they do not consider the cumulative effects of the total examination time. TI and MI models contain practical simplifications to complex bioeffects interaction. Then the operator should be aware that the actual worst case temperature rise may be up to several times higher than the displayed TI value. |
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