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


Electrical equipment in medical practice



Reference FprEN 60601-2-24:2012
Title Medical electrical equipment - Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers
Project Number 22587
Abstract/Scope IEC 60601-2-24:2012 applies to the basic safety and essential performance of infusion pumps and volumetric infusion controllers. This standard applies to administration sets insofar as their characteristics influence the basic safety or essential performance of infusion pumps and volumetric infusion controllers. However this standard does not specify requirements or tests for other aspects of administration sets. This particular standard specifies the requirements for enteral nutrition pumps, infusion pumps, infusion pumps for ambulatory use, syringe or container pumps, volumetric infusion controllers and volumetric infusion pumps. This particular standard does not apply to the following: devices specifically intended for diagnostic or similar use; devices for extracorporeal circulation of blood; implantable devices; equipment specifically intended for diagnostic use within urodynamics; equipment specifically intended for diagnostic use within male impotence testing; and devices covered by ISO 28620. This second edition cancels and replaces the first edition of IEC 60601-2-24. This edition constitutes a technical revision according to IEC 60601-1:2005+A1:2012 with new clause numbering, including usability and alarms.
Approval stage


Current Stage code 5091
Current Stage code date 2012-09-25
Current Stage code deadline  
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 60601-2-24:2012 (EQV)
ICS 11.040.20 - Transfusion, infusion and injection equipment
Keywords Medical; Infusion; Pump; Controller; Safety
Note Will supersede EN 60601-2-24:1998
Special National Condition(s)  


Categories - Aspects
Product Life Cycle


Deadline Date
5091 2012-09-25    
5060 2012-09-24 2012-10-15 export to doc file  EN
5020 2012-07-20 2012-09-21  
3090 2010-04-16 2012-05-31  
5060 2009-12-21 2010-01-04 export to doc file  EN
5020 2009-07-17 2009-12-18  
1090 2009-07-14 2009-07-17  

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 60601-2-24:1998
Superseded by  
Normative reference (6)  

(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.