ISO/IEEE 11073 standards

[mwaller]

Hello!
My company manufactures sensors and instrumentation for invasive blood pressure measurements. We are developing a stand-alone blood pressure monitor with an interface that will allow the pressure measurement waveform to be simultaneously displayed on a patient monitor. This monitor interface is analog, and is designed to simulate the output of a arterial line strain gauge transducer.
A prospective customer recently asked whether the monitor interface could/should be digital and made to comply with ISO/IEEE 11073...
My limited research suggests that the 11073 standards are most commonly applied to personal medical devices in the home healthcare market. Is this true?
Are there any standards that are relevant to digital interfaces between a measurement device and patient monitors in the hospital environment?
Thanks!!

 

[Hi_Its_Matt]

This is not at all my area of expertise, but just quickly Googling and browsing ISO's site, it looks like the ISO/IEEE 11073 series has Parts related to both "Point-of-care medical device communication" as well as "Personal health device communication."
Have you looked at both?
This is from the Introduction of 11073-20101:2004 (underline emphasis is mine)

ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are to

• Provide real-time plug-and-play interoperability for patient-connected medical devices.
• Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care environments.

It looks to me like the following may be applicable:

• 11073-20101:2004 - Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard
• 11073-10101:2020 - Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature
• 11073-10201:2020 - Health informatics — Device interoperability — Part 10201: Point-of-care medical device communication - Domain information model