IEC 60601-1-11 Testing Laboratories — Home Healthcare Environment
IEC 60601-1-11 is the collateral standard addressing medical electrical equipment and systems intended for use in the home healthcare environment, where the user, supervision and physical conditions differ from a professional facility.
When is it used?
- Devices intended for use by patients or lay operators at home
- Extending a facility device into home, transport or ambulatory use
- Battery-operated and portable device programmes
Sample considerations
- State the intended environments and user profile up front; they change the applicable requirements.
- Provide the carrying case, mounts, power supplies and accessories that ship with the device.
- This collateral standard is applied alongside the general standard and the electromagnetic disturbances collateral standard.