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ILNAS-EN 60601-2-16:2015 Edition 06/2015
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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Abstract

IEC 60601-2-16:2012 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2012 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2012 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2012 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fourth edition cancels and replaces the third edition of IEC 60601-2-16, published in 2008. This edition constitutes a technical revision. Changes since the previous edition include, among others, better adaptation of IEC 60601-1-8 and improvement of subclause 201.8.3.

Status

Standard - Active

Origin

Technical Committee :
CLC/TC 62 : Electrical equipment in medical practice

Directives

93/42/EEC : Medical devices

Implementation

start of the vote on the project    03/12/2010   date of ratification (dor)   
end of the vote on the project    03/02/2011   date of anouncement (doa)    14/07/2015
start of the vote on the final project    23/12/2011   date of publication (dop)    14/01/2016
end of the vote on the final project    23/02/2012   date of withdrawal (dow)    14/04/2018


Publication Official Journal
of the Grand-Duchy of Luxembourg
31/12/2015
Reference

Relations

Evolutions
ILNAS-EN IEC 60601-2-16:2019

Relations to older standards
ILNAS-EN 60601-2-16:1998
FprEN 60601-2-16:2008

Relations to international standards
IEC 60601-2-16:2012 (EQV) 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment
11.040.25 : Syringes, needles and catheters

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