BS EN IEC 60601-2-16:2019

What is BS EN IEC 60601-2-16-Haemodialysis, haemodiafiltration, and haemofiltration equipment about?  

BS EN IEC 60601-2-16 is part 2-16 of the multi-series standard that discusses medical electrical equipment. BS EN IEC 60601-2-16 outlines the basic safety and essential performance of hemodialysis, haemodiafiltration, and haemofiltration equipment, hereafter referred to as haemodialysis equipment. 

BS EN IEC 60601-2-16 establishes basic safety and essential performance requirements for haemodialysis equipment. 

BS EN IEC 60601-2-16 layouts the minimum safety requirements for haemodialysis equipment. this haemodialysis equipment is intended for use either by medical staff or for use by the patient or other trained personnel under medical supervision. 

BS EN IEC 60601-2-16 includes all me equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient, independent of the treatment duration and location. 

Who is BS EN IEC 60601-2-16-Haemodialysis, haemodiafiltration, and haemofiltration equipment for? 

BS EN IEC 60601-2-16 on haemodialysis, haemodiafiltration, and haemofiltration equipment is useful to: 

• Manufacturers of haemodialysis, haemodiafiltration, and haemofiltration equipment 
• Test centres for ME equipment 
• Haemodialysis, haemodiafiltration, and haemofiltration equipment operators 
• Regulatory authorities 

Why should you use BS EN IEC 60601-2-16-Haemodialysis, haemodiafiltration, and haemofiltration equipment? 

Haemodialysis equipment ME equipment or ME system used to perform haemodialysis, haemodiafiltration and/or haemofiltration. Haemodialysis process whereby concentrations of water-soluble substances in a patient's blood and an excess of fluid of a patient are corrected by bidirectional diffusive transport and ultrafiltration across a semi-permeable membrane separating the blood from the dialysis fluid. 

BS EN IEC 60601-2-16 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 haemodialysis, haemodiafiltration, and haemofiltration equipment. This improves the performance and safety of haemodialysis, haemodiafiltration, and haemofiltration equipment. This minimizes hazards to the patient and operator. 

What’s changed since the last update? 

BS EN IEC 60601-2-16:2019 supersedes IEC 60601-2-16:2012, which has been withdrawn. BS EN IEC 60601-2-16:2019 has some technical changes with respect to IEC 60601-2-16:2012. These include: 

• Update of 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, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2016 
• Widening of the scope 
• Editorial improvements 
• Addition of requirements for anticoagulant delivery means 
• Other few small technical changes