IEC 60601-2-24:2012

Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

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.

Appareils électromédicaux - Partie 2-24: Exigences particulières pour la sécurité de base et les performances essentielles des pompes et régulateurs de perfusion

La CEI 60601-2-24:2012 s'applique à la sécurité de base et aux performances essentielles des pompes à perfusion et des régulateurs de perfusion volumétriques. La présente norme s'applique aux nécessaires de perfusion dans la mesure où leurs caractéristiques ont une influence sur la sécurité de base ou sur les performances essentielles des pompes à perfusion et des régulateurs de perfusion volumétriques. Toutefois, la présente norme n'indique pas d'exigences ou d'essais pour d'autres aspects des nécessaires de perfusion. La présente norme particulière spécifie les exigences applicables aux pompes de nutrition entérale, aux pompes à perfusion, aux pompes à perfusion à usage ambulatoire, aux pousse-seringues ou réservoirs, aux régulateurs de perfusion volumétriques et aux pompes à perfusion volumétriques. La présente norme particulière ne s'applique pas aux appareils suivants: les appareils spécifiquement destinés au diagnostic ou à un usage de même nature; les appareils de circulation extracorporelle de sang; les appareils implantables; les appareils spécifiquement destinés au diagnostic urodynamique; les appareils spécifiquement destinés au diagnostic de l'impuissance; et les appareils couverts par l'ISO 28620. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-24, dont elle constitue une révision technique conformément à la CEI 60601-1:2005+A1:2012, avec une nouvelle numérotation des articles, y compris l'aptitude à l'utilisation et les alarmes.

General Information

• Status: Published
• Publication Date: 18-Oct-2012
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: WG 23 - TC 62/SC 62D/WG 23
• Current Stage: PPUB - Publication issued
• Start Date: 15-Nov-2012
• Completion Date: 19-Oct-2012

Relations

• Revises: IEC 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-24 ®
Edition 2.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-24: Particular requirements for the basic safety and essential performance
of infusion pumps and controllers

Appareils électromédicaux –
Partie 2-24: Exigences particulières pour la sécurité de base et les performances
essentielles des pompes et régulateurs de perfusion

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IEC 60601-2-24 ®
Edition 2.0 2012-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-24: Particular requirements for the basic safety and essential performance

of infusion pumps and controllers

Appareils électromédicaux –
Partie 2-24: Exigences particulières pour la sécurité de base et les performances

essentielles des pompes et régulateurs de perfusion

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.20 ISBN 978-2-83220-417-7

– 2 – 60601-2-24  IEC:2012
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 9
201.3 Terms and definitions . 9
201.4 General requirements . 12
201.5 General requirements for testing of ME EQUIPMENT . 13
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 13
201.7 ME EQUIPMENT identification, marking and documents. 13
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 15
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 *Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 35
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 35
201.15 Construction of ME EQUIPMENT . 35
201.16 ME SYSTEMS . 37
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 37
202 Electromagnetic compatibility – Requirements and tests . 37
206 Usability . 38
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 38
Annexes . 42
Annex AA (informative) Particular guidance and rationale . 43
Bibliography . 58
Index of defined terms used in this particular standard. 59

Figure 201.103 – Analysis periods . 22
Figure 201.104a – Test apparatus for VOLUMETRIC INFUSION PUMPS and VOLUMETRIC
INFUSION CONTROLLERS . 22
Figure 201.104b – Test apparatus for SYRINGE OR CONTAINER PUMPS . 23
Figure 201.104 – Test apparatuses for different types of INFUSION PUMPS . 23
Figure 201.105 – Start-up graph plotted from data gathered during the first 2 h of the
test period . 23
Figure 201.106 – Trumpet curve plotted from data gathered during the second hour of
the test period . 24
Figure 201.107 – Trumpet curve plotted from data gathered during the last hour of the
ADMINISTRATION SET CHANGE INTERVAL . 24
Figure 201.108 – Start-up graph over the stabilization period . 25
Figure 201.109 – Trumpet curve plotted from data at the end of the stabilization period . 25

60601-2-24  IEC:2012 – 3 –
Figure 201.110 – Start-up curve over the stabilization period for quasi-continuous
output pumps . 26
Figure 201.111 – Trumpet curve plotted from data at the end of the stabilization period
for quasi-continuous pumps . 26
Figure 201.112 – Test apparatus to determine the OCCLUSION ALARM THRESHOLD and
BOLUS volumes . 33
Figure AA.101 – Start-up graph . 49
Figure AA.102 – Trumpet curve . 49
Figure AA.103 – Calculation for E (max.) and E (min.) . 52
p p
Figure AA.104 – Sampling protocol . 53
Figure AA.105 – Observation windows . 54
Figure AA.106 – Distribution of parent variate X . 55
Figure AA.107 – Distribution of observation windows . 56
Figure AA.108 – The statistical trumpet graph . 56

Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 12
Table 201.102 – Set rates, BOLUS volumes and test apparatus for the accuracy tests of
12.1.102 to 12.1.107 . 31
Table 202.101 – Test levels . 37
Table 208.101 – ALARM CONDITION priorities and related situations . 39
Table 208.102 – * Characteristics of the PULSE of auditory ALARM SIGNALS . 40

– 4 – 60601-2-24  IEC:2012
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-24: Particular requirements for the basic safety and essential
performance of infusion pumps and controllers

FOREWORD
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