Draft Details

Designation:C22.2 NO. 60601-2-16
Review start date:May 8, 2019
Review end date:Jul 7, 2019
Contact email:mary.morgan(at)csagroup.org
Draft Scope/Description:


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

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