Roland chung
Trusted Information Resource
Hello folks,
Does anyone here have experience on infusion pump? We are developing an infusion pump. When I read IEC 60601-2-24, I felt that the requirements for protective systems are equivocal. Our infusion pump uses a CPU. I am wondering if two CPUs (one for control, the other for protection) are necessary. If one CPU use, it seems that the CPU should have heavy self-monitoring.
Could somebody tell me what do the requirements below exactly mean?
Thanks,
Roland
Does anyone here have experience on infusion pump? We are developing an infusion pump. When I read IEC 60601-2-24, I felt that the requirements for protective systems are equivocal. Our infusion pump uses a CPU. I am wondering if two CPUs (one for control, the other for protection) are necessary. If one CPU use, it seems that the CPU should have heavy self-monitoring.
Could somebody tell me what do the requirements below exactly mean?
Acceptable methods of complying with this requirement are, for example:
1) a safety system check initiated and controlled by the EQUIPMENT, first at the beginning of the ADMINISTRATION SET CHANGE INTERVAL, and then repeated continuously as warranted;
2) one or more protective systems checks initiated by the OPERATOR and controlled by the EQUIPMENT within the ADMINISTRATION SET CHANGE INTERVAL, with the OPERATOR initiating checks before or during the infusion;
3) a safety system check carried out by the OPERATOR at least once within the ADMINISTRATION SET CHANGE INTERVAL
Thanks,
Roland