TS EN 60601-1-6 Electrical Medical Equipment - Part 1-6: General Rules for Basic Safety and Required Performance - Auxiliary Standard: Ease of Use

The IEC 60601-1-6 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), is a series of international standards on electrical medical devices covering basic safety and essential performance for both medical devices and medical systems. It is part of the standard. This standard is particularly relevant to the usability of electrical medical devices. It also does not complement the IEC 60601-1 standard.

This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-6 Electrical medical equipment - Part 1-6: General rules for basic safety and required performance - Auxiliary standard: Ease of use.

The IEC 60601-1-6 standard covers companies producing medical electrical and electronic devices and components, supplier companies and organizations using these devices, hospitals and all health institutions, people working in the field of health and safety, and health regulatory organizations.

The said assurance standard provides a method for a manufacturer to test, analyze, design and verify the usability of security and performance-related devices. As medical devices develop, their usage areas are expanding. Therefore, the usability of these devices always needs to be improved. This standard outlines the processes that evaluate the risks posed by problems for normal use and reduce these risks. This standard is also normal It also describes the risks for non-use, but does not consider these risks.

This standard is systematically reviewed by experts to take into account the continuity of the market and technological developments.

Tests in accordance with IEC 60601-1-6 standard are also carried out by our organization within the scope of medical device tests.