Medical devices are crucial to applying various medical techniques; therefore, special attention needs to be paid to their design and manufacturing process. The standards are specified for the safety and performance evaluation of medical devices. Adequate measures are taken to ensure the safe handling and efficient usage of a wide range of medical equipment. The periodic check of the medical equipment proves fruitful in the timely amendments and industrial innovations while administering public health.
IEC 60601 is a widely accepted series of international standards for the Basic Safety and Essential Performance of Medical Electrical devices. Medical devices are evaluated as per IEC 60601, a widely accepted series of international standards.
Risk perception and control are the essential areas to be focused on for the safety and performance enhancement of medical equipment. Experience guides are issued to bring improvements in the usage of medical devices. Quality Management systems are devised to address innovation. Documentation and record-keeping are initiated to ensure a proper check on the reliability of various medical devices.
Efficient studies, globally accepted standards, and practical techniques are applied to evaluate the performance and quality of medical equipment. Medical device products must be tested following the internationally accepted standards for the basic safety and efficient performance.
ASTM E572 test method covers the analysis of stainless and alloy steels by Wavelength Dispersive X-ray Fluorescence Spectrometry (WDXRF). It provides rapid, multi-element determinations with sufficient accuracy to assure product quality.
The ASTM D2674 is a standard test method for the analysis of sulfochromate etches solution used in the surface preparation of aluminum. The ASTM D2674 standard specifies a method for determining the efficacy of an etchant used to prepare the surface of aluminum alloys for subsequent adhesive bonding.
An immunological method for quantization of Hevea Natural Rubber (HNRL) proteins using rabbit anti-HNRL serum. Rabbits immunized with HNRL proteins react to the majority of the proteins present, and their sera have the capability to detect most if not all the proteins in HNRL.
ASTM G65 measures the resistance of metallic materials to abrasion using the dry sand/rubber wheel apparatus. The quality, durability, and toughness of the sample are determined using this test. Metallic materials are ranked in their resistance to scratching abrasion under a controlled environment.
ASTM E2141 test methods provide accelerated aging and monitoring of the performance of time-dependent electrochromic devices (ECD) integrated in insulating glass units (IGU). This test helps to understand the relative serviceability of electrochromic glazings applied on ECD.
ASTM C724 test method is used in analyzing the quality and ease of maintenance of a ceramic decoration on architectural-type glass. This test method is useful in the acknowledgment of technical standards.
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