PD IEC/TR 60601-4-1:2017

What is PD IEC/TR 60601‑4‑1- Medical electrical equipment about?  

PD IEC/TR 60601‑4‑1 discusses medical electrical equipment with a focus on guidance and interpretation and medical electrical equipment and medical electrical systems employing a degree of autonomy. PD IEC/TR 60601‑4‑1 intended to help manufacturers through the key decisions and steps to be taken to perform detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).  

PD IEC/TR 60601‑4‑1 provides a definition of DOA of MEE or MES and a MEDICAL ROBOT, and also provides guidance on: 

• Methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA 
• Considerations of basic safety and essential performance for an MEE and MES with a DOA  
• Identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA 
• Distinguishing between medical robots, and other MEE and MES 

Who is PD IEC/TR 60601‑4‑1 - Medical electrical equipment for? 

PD IEC/TR 60601‑4‑1 on medical electrical equipment is useful for: 

• Manufactures of oxygen concentrator equipment and their accessories. 
• Test centres for medical electrical equipment 
• Hospitals and non-hospital environments where oxygen concentrator equipment is used 
• Operators and end-users of oxygen concentrator equipment 

Why should you use PD IEC/TR 60601‑4‑1 - Medical electrical equipment?  

PD IEC/TR 60601‑4‑1 is an informative document, which is intended to provide existing and future designers of medical electrical equipment or medical electrical systems some guidance and direction concerning the adoption of DOA. PD IEC/TR 60601‑4‑1 is not applicable as a base for a testing procedure or writing a test protocol template. 

PD IEC/TR 60601‑4‑1 provides guidance to help the manufacturers in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. PD IEC/TR 60601‑4‑1 intended as guidance for future standard writers. PD IEC/TR 60601‑4‑1 provides guidelines and examples on how to classify autonomy through the definition of degree of autonomy.