ISO 13485:2016 Procedure - Statistical Techniques - both the Statistical Techniques Procedure and the Root Cause Analysis Procedure are used to address the requirements for 8.4. This procedure is used to analyze data and make improvements. The Root Cause Analysis Procedure is used to look into nonconformance's.
Health informatics — Device interoperability — Part 10201: Point-of-care medical device communication — Domain information model (ISO/IEEE 11073-10201:2020)
Health informatics — Device interoperability — Part 10404: Personal health device communication — Device specialization — Pulse oximeter (ISO/IEEE 11073-10404:2022)
Health informatics — Device interoperability — Part 10408: Personal health device communication — Device specialization — Thermometer (ISO/IEEE 11073-10408:2022)
Health informatics — Device interoperability — Part 10415: Personal health device communication — Device specialization — Weighing scale (ISO/IEEE 11073-10415:2022)