EN 60601-24:2018 is a professional technical standard in the field of medical electrical equipment. It specifies particular requirements for the safety and performance of sleep apnea breathing therapy devices. This international standard is applicable to such devices that are intended for use in the home environment, as well as those used in healthcare facilities.
Benefits of EN 60601-24:2018
Full compliance with EN 60601-24:2018 ensures that sleep apnea breathing therapy devices meet stringent safety and performance requirements. These devices play a crucial role in treating individuals suffering from sleep apnea, a disorder characterized by interrupted breathing during sleep. The standard helps ensure that these devices effectively deliver the required therapy while minimizing potential risks to patients.
By complying with EN 60601-24:2018, manufacturers can demonstrate the quality and safety of their sleep apnea breathing therapy devices to regulatory bodies, healthcare organizations, and consumers. This certification provides assurance that the devices have been assessed and verified by an accredited testing laboratory against rigorous criteria.
Key Requirements of EN 60601-24:2018
EN 60601-24:2018 outlines several key requirements that sleep apnea breathing therapy devices must meet. These include:
Safety: The standard mandates strict safety measures to ensure that the devices do not pose harm to patients or operators. It covers aspects such as electrical safety, mechanical safety, and protection against electromagnetic disturbances.
Performance: Sleep apnea breathing therapy devices must meet defined performance criteria to ensure their effectiveness in treating sleep apnea. This includes delivering the required pressure levels to maintain a patient's airway passages open during sleep.
Labeling and Instructions for Use: EN 60601-24:2018 requires manufacturers to provide clear and comprehensive labeling and instructions for use. This helps healthcare professionals and patients understand the correct operation, maintenance, and potential risks associated with the devices.
Conclusion
EN 60601-24:2018 is an important technical standard that governs the safety and performance of sleep apnea breathing therapy devices. Compliance with this international standard enables manufacturers to demonstrate the quality and effectiveness of their devices while ensuring patient safety. By meeting the requirements outlined in EN 60601-24:2018, manufacturers can gain the trust and confidence of regulatory bodies, healthcare facilities, and individuals seeking effective treatment for sleep apnea.
Nina She