The EN 80001-1 standard, developed by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes risk management criteria for computer networks related to the use of medical devices. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN 80001-1: Implementation of risk management for IT networks related to medical devices - Part 1: Roles, responsibilities and activities.
The aforementioned standard defines the roles, responsibilities and activities required for risk management of computer networks in which medical devices are used in order to identify and ensure that medical devices are included in computer technology networks in order to achieve desired features such as interoperability, efficiency and data and system security. This standard does not specify acceptable levels of risk. However, it is valid throughout the life cycle of information technology networks on which medical devices are located.
A risk management must be implemented to address the following key features suitable for an information technology network on which medical equipment is placed:
Risk management activities defined in the EN 80001-1 standard have been derived from the ISO 14971 standard. The relationship between the ISO 14971 standard and the standard appendix is explained. This standard applies after a medical device has been purchased by a responsible organization.
Within the scope of laboratory services, our organization also provides risk management criteria and testing services for computer networks related to the use of TS EN 80001-1 medical devices.
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