EN 60601-2-24:1998

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

Specifies the requirements for infusion pumps, infusion controllers, syringe pumps and pumps for ambulatory use. These devices are intended for use by medical staff and home patients as prescribed and medically indicated. It is the responsibility of the manufacturer to ensure that the requirements of this standard are reliably implemented.

Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit von Infusionspumpen und Infusionsreglern

Appareils électromédicaux - Partie 2-24: Règles particulières de sécurité des pompes et régulateurs de perfusion

Medicinska električna oprema - 2-24. del: Posebne varnostne zahteve za infuzijske črpalke in krmilnike (IEC 60601-2-24:1998)

General Information

• Status: Withdrawn
• Publication Date: 13-Apr-1998
• Withdrawal Date: 31-Dec-2000
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Parallel Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 14-Apr-2018
• Completion Date: 14-Apr-2018
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998)

Relations

• Replaced By: EN 60601-2-24:2015 - Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-24:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]DLQIX]LMVNH
þUSDONHLQNUPLOQLNH,(&
Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion
pumps and controllers (IEC 60601-2-24:1998)
Medizinische elektrische Geräte - Teil 2-24: Besondere Festlegungen für die Sicherheit
von Infusionspumpen und Infusionsreglern (IEC 60601-2-24:1998)
Appareils électromédicaux - Partie 2-24: Règles particulières de sécurité des pompes et
régulateurs de perfusion (CEI 60601-2-24:1998)
Ta slovenski standard je istoveten z: EN 60601-2-24:1998
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN 60601-2-24:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-2-24:1998

---------------------- Page: 2 ----------------------

SIST EN 60601-2-24:1998

---------------------- Page: 3 ----------------------

SIST EN 60601-2-24:1998

---------------------- Page: 4 ----------------------

SIST EN 60601-2-24:1998

---------------------- Page: 5 ----------------------

SIST EN 60601-2-24:1998

---------------------- Page: 6 ----------------------

SIST EN 60601-2-24:1998
INTERNATIONAL IEC
STANDARD 60601-2-24
First edition
1998-02
Medical electrical equipment –
Part 2-24:
Particular requirements for the safety of infusion
pumps and controllers
Appareils électromédicaux –
Partie 2-24:
Règles particulières de sécurité des pompes et régulateurs
de perfusion
 IEC 1998 Copyright - all rights reserved  Droits de reproduction réservés
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in
utilisée sous quelque forme que ce soit et par aucun any form or by any means, electronic or mechanical,
procédé, électronique ou mécanique, y compris la photo- including photocopying and microfilm, without permission in
copie et les microfilms, sans l'accord écrit de l'éditeur. writing from the publisher.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
Commission Electrotechnique Internationale PRICE CODE
XB
International Electrotechnical Commission
For price, see current catalogue

---------------------- Page: 7 ----------------------

SIST EN 60601-2-24:1998
– 2 – 60601-2-24 © IEC:1998(E)
CONTENTS
Page
FOREWORD . 4
INTRODUCTION . 5
Clause
SECTION ONE – GENERAL
1 Scope and object . 6
2 Terminology and definitions . 7
3 General requirements . 10
5 Classification . 11
6 Identification, marking and documents . 11
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 13
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification . 14
17 Separation. 14
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS. 14
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength. 16
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
36 Electromagnetic compatibility. 17
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility . 19
47 Electrostatic charges . 20
49 Interruption of the power s
...