INA827: Is the product suitable for Class 2 medical devices?

Hi Michelle,

Our INA821 and INA826 instrumentation amplifiers (IA) are used in electrocardiogram (ECG) and pacemaker applications, which are Class II/Class III medical devices. INA827 Instrumentation amplifier is in the same IA family (INA827 has a minimum gain of 5), and it can be used in Class II medical devices. 

Q: Also if it is possible, the operating relative humidity (RH) and operating pressure.

All ICs are encapsulated with epoxy composite molding compounds, which it should have good physical/chemical resistances against environmental changes such as operating temperature, humidity/moisture, pressure etc.. In the datasheet, operating temperature range and electrical performances are typically listed and guaranteed. Certain part numbers are certified for specific applications such as automotive, military, aerospace application etc., and these specification and part numbers should be listed in the datasheet.

Normal environmental changes in humidity and pressure have limited or no effects in IC electrical performance in general. Of course, designers can always add additional environmental protections against changes for a given application such as improving EMI/EMC rejections, faraday shielding, conformal coating on components, humidity/water soaking protection etc..

In addition, I believed that CLASS II medical devices are required to pass certain stringent regulatory controls for design assurance in operating under wide environmental conditions and safety consideration. These certification tests should include the standard humidity and operating pressure tests.

If you have additional questions, please let me know. 

Best,

Raymond