Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Scope:
International standard IEC 60601-2-16 has been prepared by IEC technical committee on electrical equipment in medical practice. This 5th edition cancels and replaces the previous edition of IEC 60601-2-16:2012. This new edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
- Update of references to :
o IEC 60601-1:2005 + AMD1:2012
o IEC 60601-1-2:2014
o IEC 60601-1-6:2010 + AMD1:2013
o IEC 60601-1-8:2006 + AMD1:2012
o IEC 60601-1-9:2007 + AMD1:2013
o IEC 60601-1-10:2007 + AMD1:2013
o IEC 60601-1-11:2015
- Widening of the scope of IEC 60601-2-16
- Editorial improvements
- Addition of requirements for anticoagulant delivery means
- Other few small technical changes
The particular requirements in this standard does not apply to:
- Extracorporeal circuits
- Dialysers
- Dialysis fluid concentrates
- Dialysis water supply systems
- Central delivery systems for dialysis fluid concentrates
- Equipment used to perform peritoneal dialysis
Project need:
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Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.