BS EN IEC 60601-2-39:2019

What is BS EN IEC 60601-2-39-Peritoneal dialysis equipment about?  

BS EN IEC 60601-2-39 is part 2-39 of the multi-series standard that discusses medical electrical equipment. BS EN IEC 60601-2-39 outlines the basic safety and essential performance of peritoneal dialysis equipment as defined in 201.3.208, hereafter referred to as PD equipment.  

BS EN IEC 60601-2-39 applies to PD equipment intended for use either by medical staff or under the supervision of medical experts, including PD equipment operated by the patient, regardless of whether the PD equipment is used in a hospital or domestic environment. 

BS EN IEC 60601-2-39 can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury, or disability. 

Note 1- 

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of BS EN IEC 60601-2-39 are not covered by specific requirements BS EN IEC 60601-2-39 except in 7.2.13 and 8.4.1 of the general standards. 

Note 2- 

These requirements do not apply to the dialysing solution or the dialysing solution circuit. 

Who is BS EN IEC 60601-2-39-Peritoneal dialysis equipment for? 

BS EN IEC 60601-2-39 on peritoneal dialysis ME equipment is useful for: 

• Manufacturers of peritoneal dialysis equipment 
• Medical laboratories using peritoneal dialysis ME equipment 
• Regulatory authorities 

Why should you use BS EN IEC 60601-2-39-Peritoneal dialysis equipment? 

Peritoneal dialysis equipment is used to perform automated peritoneal dialysis. A machine called a cycler fills and empties your belly three to five times during the night while you sleep. A fluid meter is in the cycler measures and records how much solution the cycler removes.  peritoneal dialysis ME equipment used to perform peritoneal dialysis including ADP ME equipment. 

BS EN IEC 60601-2-39 guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for peritoneal dialysis equipment.  

BS EN IEC 60601-2-39 improves the performance and safety of peritoneal dialysis equipment and minimizes hazards to the patient and operator. 

What’s changed since the last update? 

BS EN IEC 60601-2-39:2019 supersedes IEC 60601-2-39:2007, which has been withdrawn. BS EN IEC 60601-2-39:2019 has some technical changes with respect to IEC 60601-2-39:2007. These include: 

• Update of the references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1- 8:2006 and IEC 60601-1-8:2006/AMD1:2012 and of references and requirements to IEC 60601-1-11:2015 
• Editorial improvements 
• Improvement of the essential performance requirements clause/subclauses 
• New requirements for the interruption of the power supply