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ILNAS-EN 60601-2-16:1998 Edition 04/1998
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
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Abstract

Specifies the minimum safety requirements for single patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.

Status

Standard - Superseded

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      date of ratification (dor)   
end of the vote on the project      date of anouncement (doa)    01/07/1998
start of the vote on the final project    17/10/1997   date of publication (dop)    01/01/1999
end of the vote on the final project    17/12/1997   date of withdrawal (dow)    01/01/2001


Publication Official Journal
of the Grand-Duchy of Luxembourg
03/06/1998
Reference

Relations

Evolutions
ILNAS-EN 60601-2-16:2015
FprEN 60601-2-16:2008

Relations to older standards
HD 395.2.16 S1:1989

Relations to international standards
IEC 60601-2-16:1998 (EQV) 

International Classification for Standards (ICS codes) :

11.040 : Medical equipment
11.040.20 : Transfusion, infusion and injection equipment

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