EN 60601-2-25:1995

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs

Specifies the particular safety requirements for electrocardiographs, intended for the production of detachable electrocardiograms for diagnostic purposes. Also applies to vectorcardiographs and equipment for stress testing.

Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit von Elektrokardiographen

Appareils électromédicaux - Partie 2-25: Règles particulières de sécurité des électrocardiographes

Précise les règles particulières de sécurité des électrocardiographes, destinés à produire des électrocardiogrammes détachables à des fins de diagnostic. S'applique aussi aux vectocardiographes et aux ergomètres.

Medicinska električna oprema - 2-25. del: Posebne varnostne zahteve za elektrokardiografe (IEC 60601-2-25:1993)

General Information

• Status: Withdrawn
• Publication Date: 29-Nov-1995
• Withdrawal Date: 30-Jun-1996
• ICS: 11.040.50 - Radiographic 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: 15-Sep-2018
• Completion Date: 15-Sep-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 60601-2-25:1998 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993)

Relations

• Replaced By: EN 60601-2-25:2015 - Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
• Effective Date: 28-Jan-2023
• Amended By: EN 60601-2-25:1995/A1:1999 - Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-25:1998
01-september-1998
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
HOHNWURNDUGLRJUDIH,(&
Medical electrical equipment - Part 2-25: Particular requirements for the safety of
electrocardiographs (IEC 60601-2-25:1993)
Medizinische elektrische Geräte - Teil 2-25: Besondere Festlegungen für die Sicherheit
von Elektrokardiographen (IEC 60601-2-25:1993)
Appareils électromédicaux - Partie 2-25: Règles particulières de sécurité des
électrocardiographes (CEI 60601-2-25:1993)
Ta slovenski standard je istoveten z: EN 60601-2-25:1995
ICS:
11.040.50 Radiografska oprema Radiographic equipment
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
SIST EN 60601-2-25:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-25:1998

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

SIST EN 60601-2-25:1998

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

SIST EN 60601-2-25:1998

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

SIST EN 60601-2-25:1998

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

SIST EN 60601-2-25:1998

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

SIST EN 60601-2-25:1998
NORME
CEI
INTERNATIONALE
IEC
601-2-25
INTERNATIONAL
Première édition
STANDARD
First edition
1993-03
Appareils électromédicaux
Partie 2:
Règles particulières de sécurité
des électrocardiographes
Medical electrical equipment
Part 2:
Particular requirements for the safety
of electrocardiographs
CEI 1993
© Droits de reproduction réservés — Copyright — all rights reserved
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 pro-
any form or by any means, electronic or mechanical,
cédé, électronique ou mécanique, y compris la photocopie et including photocopying and microfilm, without permission
les microfilms, sans l'accord écrit de l'éditeur. in writing from the publisher.
Bureau Central de la Commission Electrotechnique Internationale 3, rue de Varembé
Genève, Suisse
Commission Electrotechnique Internationale CODE PRIX
International Electrotechnical Commission PRICE CODE
U
IEC
Me>KUyxapoattaa 3neKTpoTexHKVecKaa lioMKCCHR
• • Pour prix, voir catalogue en vigueur
For price, see current catalogue

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

SIST EN 60601-2-25:1998
601-2-25 ©IEC: 1993 - 3 -
CONTENTS
Page
7
FOREWORD
INTRODUCTION
SECTION ONE: GENERAL
Clause
1 11
Scope and object
2 Terminology and definitions 13
4 General requirements for tests 15
17
5 Classification
17
6 Identification, marking and documents
SECTION TWO: ENVIRONMENTAL CONDITIONS
10 Environmental conditions 19
SECTION THREE: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
17 19
Separation
21
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
21
20 Dielectric strength
SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE: PROTECTION AGAINST HAZARDS FROM UNWANTED
OR EXCESSIVE RADIATION
34 Ultraviolet radiation 23
SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 23
Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
25
sterilization and disinfection

---------------------- Page: 8 ----------------------

SIST EN 60601-2-25:1998
601-2-25 ©IEC: 1993 – 5 –
SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
Clause Page
51 Protection against hazardous output 25
SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly 31
57 MAINS PARTS, components and layout 33
Figures
101 Dynamic test for limitation of energy from different parts 35
102 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of CLASS I EQUIPMENT, caused by an external voltage on
a FUNCTIONAL EARTH TERMINAL 37
103 Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART t0 earth of INTERNALLY POWERED EQUIPMENT, caused by an
external voltage on a FUNCTIONAL EARTH TERMINAL 39
104 Test of protection against the effects of defibrillation 41
105 Test of protection against the effects of defibrillation 41
106 Arrangements for ECG ELECTRODES on sponges 43
107 Test of the recovery time from the effects of cardiac defibrillator discharge 43
APPENDIX D Symbols on marking (Symbols to indicate protection against
the effects of the discharge of a cardiac defibrillator) 45
Annexe AA General guidance and rationale 47

---------------------- Page: 9 ----------------------

SIST EN 60601-2-25:1998
- 7 -
601-2-25 © IEC: 1993
INTERNATIONAL ELECT
...