EN 60601-1-2:2001

SLOVENSKI STANDARD
01-junij-2002
1DGRPHãþD
SIST EN 60601-1-2:1995
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral
standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-
2:2001)
Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral
standard: Electromagnetic compatibility - Requirements and tests
Medizinische elektrische Geräte -- Teil 1-2: Allgemeine Festlegungen für die Sicherheit -
Ergänzungsnorm: Elektromagnetische Verträglichkeit - Anforderungen und Prüfungen
Appareils électromédicaux -- Partie 1-2: Règles générales de sécurité - Norme
collatérale: Compatibilité électromagnétique - Exigences et essais
Ta slovenski standard je istoveten z: EN 60601-1-2:2001
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-1-2
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2001
ICS 11.040.01;33.100.10;33.100.20 Supersedes EN 60601-1-2:1993
English version
Medical electrical equipment
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility -
Requirements and tests
(IEC 60601-1-2:2001)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1-2: Règles générales de sécurité - Teil 1-2: Allgemeine Festlegungen
Norme collatérale: für die Sicherheit -
Compatibilité électromagnétique - Ergänzungsnorm:
Prescriptions et essais Elektromagnetische Verträglichkeit -
(CEI 60601-1-2:2001) Anforderungen und Prüfungen
(IEC 60601-1-2:2001)
This European Standard was approved by CENELEC on 2001-11-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands,
Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
Central Secretariat: rue de Stassart 35, B - 1050 Brussels
© 2001 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-2:2001 E
Foreword
The text of document 62A/336/FDIS, future edition 2 of IEC 60601-1-2, prepared by SC 62A, Common
aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in
medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as
EN 60601-1-2 on 2001-11-01.
This European Standard supersedes EN 60601-1-2:1993.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2002-08-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2004-11-01
This European Standard is a Collateral Standard to EN 60601-1:1990, hereinafter referred to as the
General Standard.
In the EN 60601 series of publications, Collateral Standards specify general requirements for safety
applicable to:
– a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General
Standard (e.g. ELECTROMAGNETIC COMPATIBILITY).
In addition, EN 60601-1-1 has expanded the scope of the general standard to include MEDICAL
ELECTRICAL SYSTEMS. In recognition of that expanded scope, this edition of the EMC Collateral
Standard takes into account the fact that the general standard now applies to MEDICAL ELECTRICAL
SYSTEMS as well as MEDICAL ELECTRICAL EQUIPMENT and includes EMC requirements that are, in most
cases, applicable to all parts of the SYSTEM.
The numbering of sections, clauses and subclauses of this Collateral Standard corresponds with that
of the General Standard.
Subclauses and figures that are additional to those of the General Standard are numbered starting
from 201; additional annexes are lettered AAA, BBB, etc.
In this Collateral Standard, the following print types are used:
– requirements, compliance with which can be tested and definitions: in roman type;
– explanations, advice, general statements, exceptions and references: in smaller type;
– test specifications: in italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS COLLATERAL STANDARD: SMALL
CAPITALS.
NOTE Defined terms are not printed in SMALL CAPITALS in Tables 201-208, in the tables in Annex BBB and in statements
required to appear in the ACCOMPANYING DOCUMENTS or instructions for use because they are intended for the custo
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