【Medical Power】Safety considerations of medical equipment – Exploring ISO 14971 risk management
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Traditional power supply products usually perform testing, evaluation, and certification for launching based on safety regulations such as IEC/EN 62368-1 and UL1310, to ensure that hazards such as fire, electric shock and scalding will not occur under the expected usage conditions. However, is this enough?

Try to imagine what would happen if the power supply failed for patients who rely heavily on ventilators?

Due to considerations like this, the third revision of the medical safety standard IEC 60601-1 required adding evaluation and application of ISO 14971.

The full name of the regulation ISO 14971 is “Application of risk management to medical devices”, which requires manufacturers to evaluate the possible risks and hazards in the entire life cycle of medical equipment. These hazards not only include the errors and flaws that may occur during the manufacturing process, abnormal use by individual users must also be considered. Evaluations need to be performed for these risks and countermeasures to reduce to stop these risks need to be proposed. More importantly, scientific methods shall be used to verify the feasibility and effectiveness of these risk management countermeasures.

Take ventilators for example: ventilators usually have humidification functions, too. Therefore, when evaluating risk management, manufacturers need to consider the possibility of water splashing out when users refill the water tank of the humidifier, and whether any danger will be caused if the ventilator and power supply become wet.

Once an unacceptable danger is discovered, countermeasures to reduce the risk need to be proposed. Usually, a possible practice is to add waterproof design to the equipment. In this case, we need to verify the effectiveness of the waterproof design, and this may involve arranging water spray tests according to conditions such as the size of the water tank and the height of the user, to ensure that no threats will be caused to the safety of the patient even if water splashes occur. In addition, it must also be considered whether the waterproof design can have consistent effect qualities in mass production. This is the core concept of the ISO 14971 risk management.

Asian Power Devices has been focusing on the development and design of medical power for many years. It has the highest level of CTF-Stage 3 medical safety regulation laboratory among the manufacturers in the industry, and also obtained the ISO 13485 medical equipment quality management system certification. Each of APD’s medical power product fully complies with the IEC 60601-1 and ISO 14971 design and production standards to ensure that medical device customers around the world can have the safest, most reliable and most stable medical powers.