DIN VDE 0753-4-2009 透析治疗中医疗产品的安全使用指南

标准号：DIN VDE 0753-4-2009
中文标准名称：透析治疗中医疗产品的安全使用指南
英文标准名称：Guideline for the safe use of medical products in dialysis treatment - Text in German and English
标准类型：C39
发布日期：1999/12/31 12:00:00
实施日期：2009/5/1 12:00:00
中国标准分类号：C39
国际标准分类号：11.040.20
引用标准：DIN 1988-4-1988;DIN EN 60601-1-2007;DIN EN 60601-2-16;DIN EN 62353-2008;DIN EN 60309-2-2007;DIN EN ISO 14971
适用范围：The present application principles describe the technical requirements for use of equipment inHAEMODIALYSIS, HAEMOFILTRATION and HAEMODIAFILTRATION. These principles must be complied with to ensuresafe, permissible and proper application.Dialysis treatment as a whole is a medical treatment and lies, therefore, in the attending physician'sresponsibility. 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 describedhere.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 homeHAEMODIALYSIS.Today, the safety standard of SYSTEMS for extracorporeal renal replacement therapy is very high. This safetystandard relieves the OPERATOR in many areas while also protecting the PATIENT. For example, it ensuresmonitoring of the temperature of the DIALYSING FLUID and prevents air infusion during the dialysis treatmentthrough technical structures. This is expressed by the CE mark applied to the medical devices [9]. Despite thehigh safety level of the medical devices, the OPERATOR is responsible for the residual risk. The residual riskrelates to medical-biological, physical-chemical and technical HAZARDS.