TIPS for Designing to IEC 60601-1-11. By: MedicalRegs.com

TIPS For Designing Medical Devices For Home Healthcare. Some Key Areas To Consider… The collateral safety standard that applies to active medical devices is, IEC 60601-1-11. The standard was developed because, it is expected that the home environment is less controlled compared to a professional healthcare facility. A professional healthcare environment has stable ambient temperature and humidity. A professional healthcare environment has reliable protective earth system. In contrast, residential homes have unreliable PE system. Rusted and loose PE terminals = High impedance = High earth leakage current With this in mind, additional or new risks may be introduced with the use of your medical device in a home environment. In your risk assessment and design inputs, you should consider the following: Class 2 Design The user is protected from electric shock by double or reinforced insulation. Is the user of your device also the patient? If so, your IFU should reflect this. Make sure it is written in layman's terms. Validate your IFU based on user/patient profile. Consider accessibility to hazardous live and moving parts – In a home environment your device may be exposed to children too. Enclosure openings must pass accessibility test finger probe/pin. Consider electromagnetic interference in home environment. Your device will be bombarded with electromagnetic interference radiated from electronic gadgets, kitchen appliances, etc. Design for optimal immunity. Consider Ingress Protection (IP) rating. Is the device body worn? Stationary? Transportable or mobile? If it's body worn as an example, the user/patient may forget and shower or wash the dishes while the device is worn. Include this in the risk assessment. Consider strangulation & trip hazards Balance length of tubings and interconnecting cables design with associated hazards. Consider temperature, humidity, and altitude. What is the worst-case home environmental conditions can you expect based on your geographical markets? Clarity MedicalRegs.com