TS EN ISO 14971 Medical Devices - Application of Risk Management to Medical Devices

In the ISO 14971 standard developed by the International Standards Organization (ISO), the conditions and test methods of risk management practice for medical devices are explained. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 14971 Medical devices - Implementation of risk management on medical devices.

The basis of the mentioned standard is the standard CSA-14971-07 developed by the Canadian Standards Association (CSA) (CAN / CSA-ISO 14971-07 Medical Devices - Application of Risk Management to Medical Devices).

This standard provides a risk management system for all medical equipment, including in vitro diagnostic medical equipment. This system supports manufacturers in defining risks related to medical equipment, identifying and evaluating risks related to each other, controlling and monitoring the effectiveness of the controls. Requirements in this standard apply to all stages of the medical equipment life cycle. The described process applies to risks associated with a medical equipment, such as biocompatibility, data and system security, electricity, moving parts, radiation and availability.

The requirements described in the ISO 14971 standard are also applied to non-medical equipment products in some countries. However, the following situations are outside the scope of the standard:

• Decisions regarding the use of medical equipment in the context of any clinical process
• Operational risk management

This standard requires manufacturers to set objective criteria for risk acceptability, but does not specify acceptable risk levels.

In fact, risk management is a whole with the quality management system, but it does not require the manufacturer to have a quality management system. Guidelines for the implementation of this standard are included in the ISO / TR 24971 standard.

Within the scope of laboratory services, the conditions of risk management application for ISO 14971 medical devices and testing services are also provided by our organization.