trials, the present study aimed to (I) transfer the material synthesis of hyaluronic acid-based hydrogels into a routine, pharmaceutical-appropriate production and (II) evaluate the properties of the vitreous substitutes in terms of the current regulations for medical devices (MDR/ISO standards). Me...
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However, additional intravenous hydrocortisone may be needed, depending on the extent of the planned procedure, from 50 mg/day for minor surgeries to 200 mg/day for major surgeries [4]. Guidelines for perioperative supplementation of glucocorticoids were issued by the Association of Anaesthetists, th...
The equivalent regulatory requirements for medical devices in Europe include the CE marking and also compliance with ISO 9001 and 9002 standards for the manufacturing processes. Even though in each case the requirements are similar, they are not identical, and products are often required to comply ...
The equivalent regulatory requirements for medical devices in Europe include the CE marking and also compliance with ISO 9001 and 9002 standards for the manufacturing processes. Even though in each case the requirements are similar, they are not identical, and products are often required to comply ...
The International Organization for Standardization (ISO) developed a standard for biological evaluation of medical devices (ISO 10993) that is applicable to TDS [142], and the FDA has recently issued an accompanying document to these standards for thoroughly assessing the safety of TDS prior to ...
Both the USP and the International Society of Oncology Pharmacy Practitioners (ISOPP) publications on standards of practice for the safe handling of hazardous drugs discuss the above categories of safety controls at length. There is a hierarchy of efficiency in these protection measures. The top...
BS EN 60601-2-40 医疗电气设备.特殊安全要求.筋骨电流计和诱发反应设备规范 Medical electrical equipment - Particular requirements for safety - Specification for electromyographs and evoked response equipment BS EN 60738-1-1 热敏电阻.直接加热的无源分级功能温度系数.空白详细规范.控制电流应用.EZ评定级 ...
[125,126,127]. These devices have the potential to open another valuable therapeutic front in both treating the symptoms of PMD and also altering the underlying pathophysiology. Like many therapies for PMD, there is currently a lack of evidence to assess their efficacy, meaning that rigorous ...
(MHLW) and the Pharmaceuticals and Medical Devices Agency are responsible for this process [59], publishing specific guidelines for the regulation of liposome-based drug products in 2016. As in the USA and EU, the Pharmaceutical Affairs Law framework in Japan legislates nanomedicines on a case-by...