What is EN ISO 80601-2-22:2021?

EN ISO 80601-2-22:2021 is an international standard that provides requirements for the basic safety and essential performance of medical electrical equipment used in the home healthcare environment. It specifically focuses on medical electrical equipment intended for use in the monitoring, treatment, or care of a single individual.

Scope of EN ISO 80601-2-22:2021

This standard applies to a wide range of medical electrical equipment used in the home healthcare setting. It covers equipment such as ventilators, infusion pumps, sleep apnea monitors, and blood pressure monitors, among others. The scope includes both devices that are powered by batteries or mains electricity.

Main Requirements of EN ISO 80601-2-22:2021

EN ISO 80601-2-22:2021 sets out various requirements to ensure the safe and effective use of medical electrical equipment in home healthcare settings. These requirements include:

Protection against electric shock

Protection against mechanical hazards

Protection against excessive temperatures or fire risks

Ensuring adequate accuracy for vital measurements

Protecting patients, users, and operators from unintended exposure to energy sources

In addition to these requirements, the standard also addresses labeling, user manuals, and instructions for cleaning and maintenance of the equipment.

Benefits of EN ISO 80601-2-22:2021 Compliance

Complying with EN ISO 80601-2-22:2021 is crucial for manufacturers of medical electrical equipment used in the home healthcare sector. By adhering to this standard, manufacturers can:

Ensure the safety and reliability of their products

Comply with legal and regulatory requirements

Gain trust and confidence from users and healthcare providers

Reduce the risk of adverse events and liability issues

Enhance overall product quality and performance

In summary, EN ISO 80601-2-22:2021 plays a significant role in ensuring the safe and effective use of medical electrical equipment in the home healthcare environment. It provides manufacturers, healthcare providers, and users with clear guidelines and requirements for maintaining high standards of safety and performance.