IEC PAS 63023:2016 pdf download

IEC PAS 63023:2016 pdf download.Medical electrical system – Input interface for haemodialysis equipment for use of external alarming device
1 Scope
This PAS establishes a unique INPUT INTERFACE for connection of an EXTERNAL ALARMING DEVICE to HAEMODIALYSIS EQUIPMENT . The INPUT INTERFACE of the HAEMODIALYSIS EQUIPMENT is designed as a simple solution, which takes a SINGLE FAULT CONDITION of the INPUT INTERFACE into account, to stop the extracorporeal blood flow in case of needles slipping out from the fistula or graft detected by the EXTERNAL ALARMING DEVICE .
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60601 -2-1 6:201 2, Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601 -2-1 6:201 2 as well as the following terms and definitions apply: Additions: 3.1 EXTERNAL ALARMING DEVICE ACCESSORY that detects ALARM CONDITIONS 3.2 INPUT INTERFACE part of HAEMODIALYSIS EQUIPMENT providing the possibility of access to an EXTERNAL ALARMING DEVICE . 3.3 INTERNAL SIGNAL PROCESSING part of HAEMODIALYSIS EQUIPMENT intended to process signals 3.4 SIGNAL PLUG TERMINAL DEVICE of the EXTERNAL ALARMING DEVICE for the connection to the HAEMODIALYSIS EQUIPMENT SIGNAL SOCKET 3.5 SIGNAL SOCKET TERMINAL DEVICE of the INPUT INTERFACE 3.6 HAEMODIALYSIS EQUIPMENT GROUND grounding terminal connected to conductive parts for INTERNAL SIGNAL PROCESSING 3.7 SIGNAL GROUND grounding terminal connected to conductive parts for external signal processing
4 Application
4.1 Simplified circuit diagram The simplified circuit diagram in Figure 1 provides a hardware solution for an INPUT INTERFACE .4.2 Periodic functional check A failure of the INPUT INTERFACE of the HAEMODIALYSIS EQUIPMENT should become obvious to the OPERATOR at least once per day when in operational use.The check of the INPUT INTERFACE is done with the test signal (TS). For this purpose, the test signal is set to operation voltage (OV) and the test results are monitored by the INTERNAL SIGNAL PROCESSING unit. The expected test condition signals and test results are listed in Table 1 .