EUROLAB medical device specialists examine component and material microstructures, including material relationships, mechanical testing of materials, devices, packaging and testing failures. Analysis of medical device materials helps the customer understand how raw materials affect product properties and provides a thorough understanding of the structure, properties and processing relationships.
Medical Device Materials Test:
• Material integrity and deformation
• Surface morphology and adhesion studies
• Microstructure - product property relationships
• Microscopy of Medical Devices
• Mechanical testing of equipment and packaging materials
• Rheological properties and performance
• Phase distribution and chemical imaging
• Fracture and deterioration research of materials
• Pollution analysis and control audit
• Metallurgy, Corrosion, Chemical Resistance
• ASTM and ISO test for raw material verification
Medical medical device performance tests are tools that need constant control and affect human life a lot. When looking at the current medical medical device regulation, tests must be performed in accordance with all medical standards (ASTM, IEC, EN).
Medical Medical Devices is the general name for products used individually or in combination, including material software for individuals.
Material tests, Biocompatibility tests, Clean room tests and Sterilization tests are performed according to the conditions stated in the regulation.
Whether medical medical devices that require electricity can operate safely is an enormous need for companies that make electrical medical devices that comply with IEC 60601-1 standards and help identify a few risks. Medical tests should be carried out under the name of compliance with these standards.
In the IEC 60601-1 compliance test, services such as test consultancy, product labeling, examination of compliance with IEC 60601-1 standards and ISO 14971 rules for required performance and risk analysis, and the creation of required documents are required.
Information about Electrical Medical Devices
In terms of information on electrical medical devices, the IEC 60601-1 standard refers to electrical medical devices, medical consultation, and diagnosis of the disease, which are not connected to multiple power points, allowing energy transfer between patients, and are able to determine the dimensions of transport.
IEC 60601-1 has become a global need for electrical medical devices and together with many companies as a system quality certification body, IEC 60601-1 compliance, product registration in many markets, UL, CE, and CSA stamps, bidder and problem With the latest updates, IEC 60601-1: 2005 has become compulsory for each of the complementary standards to maintain the basic standard IEC 60601-1 compliance.
The Voltage Limits defined by the principles of the Machinery Safety Regulation published by the Ministries of Industry and Trade include the following devices, which are within the scope of the regulation on electrical equipment designed to be used internally, and include the following devices within the scope of the use of household appliances, audio, video. devices, basic office machines, information technology equipment, low voltage switch and control panels and electric motors, high voltage electrical switch and control panels and electric motors and many other types of transformers.
Regarding the main conformity of the Regulation, it should not damage the goods in terms of human health and safety during the operation of all these devices and machines, provided that they are properly installed, maintained and manufactured.
In addition to these devices, medical devices are also checked for conformity. In this context, physical and physicochemical tests (for example, adhesion strength, compression force, tensile strength and bending strength tests) and mechanical tests are performed in medical devices.
Manufacturing companies must apply at least one of the appropriate assessment procedures included in the regulation in order to document device conformity.
As a result of device compatibility tests, many tests are applied such as evaluating the analytical performance of various medical devices used, medical tests related to heart stents, tests related to implant materials, needles and surgical threads.
The legal regulations found during conformity tests have taken into account the standards published in many domestic or foreign organizations. Appropriate tests are performed on the devices in case of operational needs.