Health Technology Medical Equipment (General) Standards

In all industries, standards are an important way to maintain product and material compatibility. These standards also harmonize both national and international requirements. There is no other industry where product conformity is as important as the design and manufacture of medical equipment.

The medical equipment industry is responsible for the design and manufacture of a wide variety of equipment used to diagnose and treat diseases and improve patients' health. These products range from imaging equipment to artificial joints and implants.

Medical equipment is essential tools for maintaining and improving health. This equipment has direct effects on public health and quality of life and must be reliable in this regard. In order to achieve the desired results for all parties, including manufacturers, hospitals and healthcare institutions and patients, it is necessary to comply with the standards in the production of such medical equipment. These standards support the consistent quality of serving patients and healthcare professionals in a manufacturing or design process.

A few testing services provided under health technology medical equipment (generic) standards are:

• TS EN ISO 10993-2 Biological evaluation of medical devices - Part 2: Requirements for animal welfare
• TS EN 60601-1 Electrical and medical equipment - Part 1: General requirements for basic safety and performance
• TS EN 60601-1-8 Electrical medical equipment - Part 1-8: General requirements for basic safety and required performance - Auxiliary standard: EGeneral requirements, experiments and guidance for electrical medical equipment and warning systems in electrical medical systems
• TS EN ISO 14971 Medical devices - Applying risk management to medical devices
• TS EN 60601-1-6 electrical medical equipment - Part 1-6: General rules for basic safety and required performance - Auxiliary standard: Ease of use
• TS EN IEC 60601-2-31 Electrical medical equipment - Part 2-31: Specific features for the basic safety and required performance of external pacemakers with internal power supply
• TS EN 60601-2-52 Electrical medical equipment - Part 2-52: Specific features for the basic safety and required performance of patient beds
• TS EN 80001-1 Implementation of risk management for IT networks related to medical devices - Part 1: Roles, responsibilities and activities
• TS EN IEC 60601-2-46 Electrical medical equipment - Part 2-46: Specific features for basic safety and required performance of operating tables

A wide variety of testing services are provided to enterprises within the scope of laboratory services by our organization.