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New IEEE Standard – Active – Draft.MEDICAL DEVICEs that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a HEALTH IT SYSTEM to jointly execute SYSTEM FUNCTIONs. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of SYSTEM FUNCTIONs resulting from the combination of SYSTEM FUNCTION CONTRIBUTIONs from two or more MEDICAL DEVICEs. SDC PARTICIPANT KEY PURPOSEs (PKPs) are sets of requirements that enable MANUFACTURERs to make valid assumptions about BICEPS PARTICIPANTs from other MANUFACTURERs. This common understanding allows for the MANUFACTURERs to perform RISK MANAGEMENT, verification, validation, and USABILITY ENGINEERING for the safe use of SYSTEM FUNCTIONs. This standard defines requirements for SDC METRIC PARTICIPANTs in an SDC SYSTEM that comprises an IT NETWORK of MEDICAL DEVICEs to enable safe and secure contribution to SYSTEM FUNCTIONs based on the exchange of METRIC information.
Product Details
- ISBN(s):
- 9781504485432
- Number of Pages:
- 43
- File Size:
- 1 file , 710 KB
- Product Code(s):
- STDUD25311
- Note:
- This product is unavailable in Belarus, Russia