DIN VDE 0753-4:2009 PDF

Scope: The present application principles describe the technical requirements for use of equipment in HAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles must be complied with to ensure safe, permissible and proper application. Dialysis treatment as a whole is a medical treatment and lies, therefore, in the attending physician's responsibility. However, the ORGANISATION administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. If applicable, the application principles can also be used for other extracorporeal blood treatment procedures. However, different requirements may be applicable to the use of equipment in paediatrics and home HAEMODIALYSIS. Today, the safety standard of SYSTEMS for extracorporeal renal replacement therapy is very high. This safety standard relieves the OPERATOR in many areas while also protecting the PATIENT. For example, it ensures monitoring of the temperature of the DIALYSING FLUID and prevents air infusion during the dialysis treatment through technical structures. This is expressed by the CE mark applied to the medical devices [9]. Despite the high safety level of the medical devices, the OPERATOR is responsible for the residual risk. The residual risk relates to medical-biological, physical-chemical and technical HAZARDS.

DIN VDE 0753-4:2009 Referenced Document

DIN 1988-4:1988 Drinking water supply systems; drinking water protection and drinking water quality control (DVGW code of practice)
DIN EN 60309-2:2007 Plugs, socket-outlets and couplers for industrial purposes - Part 2: Dimensional interchangeability requirements for pin and contact-tube accessories (IEC 60309-2:1999 + A1:2005, modified); German version EN 60309-2:1999 + A1:2007
DIN EN 60601-1:2007 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005); German version EN 60601-1:2006
DIN EN 62353:2008 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment (IEC 62353:2007); German version EN 62353:2008
DIN EN ISO 14971 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021*， 2022-04-01 Update

2009 DIN VDE 0753-4:2009 Guideline for the safe use of medical products in dialysis treatment - Text in German and English
0000 DIN VDE 0753-4:2007