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IEC 60601-1-11 “Requirements for medical electrical equipment and medical electrical systems used in home care applications” is used to demonstrate conformity for medical equipment intended to be used in the home environment. This collateral standard is aligned with the 3rd edition of IEC 60601-1.
Why home healthcare?
As the average age of life expectancy rises, the need for more affordable, reliable and convenient healthcare has become more prominent. Mainstream technology adoption of internet and cell networks, lower prices for electronics and wide use of broadband capacity have all opened the doors for moving healthcare from the hospital and clinics to the home.
Historically, the assumption for assessing conformity of medical devices is that they will be operated by educated healthcare professionals, trained in the procedures in which the equipment will be used. As healthcare equipment moves outside of the institutions and into the home environment, there are several considerations that need to be addressed including:
- Education and training for the patient
- Caregiver Competency (Health, Strength, Knowledge, Agility)
- Data integrity
- Infrastructure and power back-up availability
- Maintenance schedule/requirements
If you think your device falls under the scope of 60601-1-11
- Determine if your device falls within the home healthcare scope. In order to determine whether or not the device falls within the scope of the home healthcare collateral standard, the manufacturer and UL will review the intended use and/or indications for use of the medical device. The intended use, to a significant extent, is based on the manufacturer’s stated uses and places of use. If the device falls within the home healthcare scope, the device will be subject to the 60601-1-11 requirements as applicable.
- Get UL involved early in the design process. UL experts can assess your design specifications for conformity to the requirements so your team has a better understanding of the requirements, and gaps between clinical use and home use applications. Knowing the differences up front can help you meet your scheduled completion date and avoid costly delays.
UL services for devices intended for home use:
- Gap Analysis for devices being used in clinical environments
- Proactive review for devices in the design or redesign stage of development
- Informative test reports which can serve as evidence in submissions to regulatory authorities such as CE Mark
- Safety testing to IEC 60601-1-11 and other applicable standards
- EMC testing to IEC 60601-1-2, 4th edition for interference with functionality and safety in the home environment
- Usability testing to IEC 60601-1-6 for non-clinical user group and patients
- Human Factors Engineering for the non-clinical user group, includingassessment of labels, instructions for use, device interface and functionality
- Interoperability testing with other required equipment, connections and interfaces
- Software Validation to address safety and reliability of algorithms
- Cybersecurity assessment to assess safety and security of patient information