IEC 60601-1-11 for Home Medical
Home medical products fall under the IEC 60601-1-11 evaluation standard, a collateral standard supplementing 60601-1 for this subgroup of medical equipment. In some cases, the clauses modify the general requirements and other clauses provide additional requirements. Of particular note, the environmental conditions for both operation and transport/storage are expanded normally requiring some extensive environmental conditioning as part of the test and evaluation program. Evaluation of vibration and shock is specified with test parameters for different types of devices. Class 1 (relying on protective earthing as a means of protection) unless permanently installed, is not suitable for home medical devices. Internally powered devices where loss of charge can degrade essential performance to the point of an unacceptable risk, a indication of charge should be included.
Documentation (user manual, etc.) adds some requirements that are unique to the home devices. Since home devices are used by lay operators, the usability of the accompanying documentation calls for evaluation of the readability by persons with a maximum of eight years of education. This need tends to be missed in the interest of minimizing content in many of these manuals. The accompanying should include a means to contact the manufacturer for assistance in setting up the device or reporting unexpected operation.
Home medical devices need attention to strangulation potential because of access by small children. A warning may not be sufficient and this risk needs to be part of the risk analysis.
Temperature control for contact areas needs to be managed in the design, especially where patient contact is involved.
The requirements of 60601-1-11 need to be considered in the initial design incorporating the physical strength and thorough documentation for this class of devices.
Washington Laboratories has extensive experience in Medical Device Testing and Evaluation. We can provide the complete evaluation of most home medical devices and offer assistance in the product development to attain compliance.
Contact us with your questions or to discuss how we can support your product approval.