International Standards and Conformity Assessment for all electrical, electronic and related technologies



Reference FprEN 60601-2-16:2008
Title Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Project Number 20652
Approval stage


Current Stage code 5091
Current Stage code date 2008-09-01
Current Stage code deadline 2009-03-01
Deadline date for vote  


Directive(s) MDD (93/42/EEC)
Mandate(s) M/295
Order Voucher  


IEC Technical Body IEC/SC 62D
Reference Document IEC 60601-2-16:2008 (EQV) + corrigendum Oct. 2008 (EQV)
ICS 11.040.20 - Transfusion, infusion and injection equipment
Keywords Medical equipment; Haemodialysis; Haemodiafiltration; Haemofiltration; Safety
Note Will supersede EN 60601-2-16:1998 * D133/C090: Ratification deferred until IEC has published a corrigendum to correct editorial errors and address the concerns raised by the MDD consultant (to allow EN to be listed in the OJEC under the MDD) * An amendment has been developed in IEC/SC 62D/MT 20 it is expected that it will be established as a project and submitted for vote as CDV.*2012-02-07: Publication editing allocated to
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
5091 2008-09-01 2009-03-01  
5061 2008-06-26 2008-09-01  
5060 2008-04-07 2008-04-21 export to doc file  EN
5020 2008-02-01 2008-04-04  
3090 2007-08-24 2007-08-31  
5060 2006-10-02 2006-10-16 export to doc file  EN
5020 2006-04-28 2006-09-29  
1090 2006-04-24 2006-04-28  

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2)  
date of Announcement (DOA) (3) dor + 3 months
date of Publication (DOP) (4) dor + 9 months
date of Withdrawal (DOW) (5) dor + 36 months


Supersedes EN 60601-2-16:1998
EN 60601-2-16:1998/corrigendum Dec. 1999
Superseded by FprEN 60601-2-16:2011
Normative reference (6) ISO 594-2
ISO 3744
ISO 8638
EN 60601-1-9:2008
EN 60601-1-10:2008
EN 61672-1

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved

(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat

(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level

(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn

(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.