EN 60601-1:2006
(Main)Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006, of July 2007, the interpretation sheet 1 of April 2008, the interpretation sheet 2 of January 2009 and the interpretation sheet 2 of May 2013 have been included in this copy.
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles
Contient les exigences concernant la sécurité de base et les performances essentielles qui sont généralement applicables aux appareils électromédicaux. Pour certains types d'appareil électromédicaux, ces exigences sont soit complétées soit modifiées par des exigences spécifiques données dans une norme collatérale ou une norme particulière. Lorsqu'il existe une norme particulière, il est recommandé de ne pas utiliser la présente norme générale seule. Le contenu des corrigendum de décembre 2006, de juillet 20007, la feuille d'interprétation 1 d'abril 2008, la feuille d'interprétation 2 de janvier 2009 et la feuille d'interprétation 3 de mai 2013 a été pris en considération dans cet exemplaire.
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti (IEC 60601-1:2005)
Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ELEKTRIČNE MEDICINSKE OPREME in ELEKTRIČNIH MEDICINSKIH SISTEMOV, v nadaljevanju ME OPREMA in ME SISTEMI. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla.Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME opreme in ME SISTEMOV v okviru področja uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1. Ta standard se lahko uporablja tudi za opremo, ki se uporablja za kompenziranje ali lajšanje bolezni, poškodbe ali prizadetosti. Diagnostična oprema in vitro, ki ni zajeta z definicijo ME OPREME, je zajeta s serijo 2 IEC 61010. Ta standard ne velja za vsadne dele aktivnih medicinskih vsadkov, ki so zajeti v ISO 14708-1. Ta EN 60601-1:2006 je bil v primerjavi z EN 60601-1:1990 precej preurejen. Zahteve v električnem delu so bile nadalje usklajene s tistimi za opremo informacijske opreme, ki jih zajema EN 60950-1, dodana je bila tudi zahteva za vključitev PROCESA ZA OBVLADOVANJE TVEGANJ. Za razširjen opis te revizije glej točko A.3.
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SLOVENSKI STANDARD
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SIST EN 60601-1:1995
SIST EN 60601-1:1995/A13:1998
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SIST EN 60601-1-1:2002
SIST EN 60601-1-4:1998
SIST EN 60601-1-4:1998/A1:2002
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Medical electrical equipment -- Part 1: General requirements for basic safety and
essential performance
Medizinische elektrische Geräte -- Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux -- Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
Ta slovenski standard je istoveten z: EN 60601-1:2006
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 60601-1
NORME EUROPÉENNE
October 2006
EUROPÄISCHE NORM
ICS 11.040 Supersedes EN 60601-1:1990 + amendments
Incorporates corrigendum March 2010
English version
Medical electrical equipment
Part 1: General requirements for basic safety
and essential performance
(IEC 60601-1:2005)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 1: Exigences générales Teil 1: Allgemeine Festlegungen
pour la sécurité de base für die Sicherheit einschließlich
et les performances essentielles der wesentlichen Leistungsmerkmale
(CEI 60601-1:2005) (IEC 60601-1:2005)
This European Standard was approved by CENELEC on 2006-09-12. 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, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the 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
© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1:2006 E
Foreword
The text of document 62A/505A//FDIS, future edition 3 of IEC 60601-1, 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 on 2006-09-12.
The following date was 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) 2007-07-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2012-06-01
This European Standard supersedes EN 60601-1:1990 and its amendments.
This EN 60601-1:2006 has been significantly restructured compared to EN 60601-1:1990.
Requirements in the electrical section have been further aligned with those for information technology
equipment covered by EN 60950-1 and a requirement for including a RISK MANAGEMENT
PROCESS has been added. For an expanded description of this revision, see Clause A.3.
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directives 90/385/EEC and 93/42/EEC. See Annex ZZ.
In this standard the following print types are used:
− requirements and definitions: in roman type;
− test specifications: in italic type;
− informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text
of tables is also in a smaller type;
− TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3 AND ALSO GIVEN IN
THE INDEX: IN SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses
of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the clause
number. References to subclauses within this standard are by number only. In this standard, the
conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions
is true.
The verbal forms used in this standard conform to usage described in Annex G of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
− “shall” means that compliance with a requirement or a test is mandatory for compliance with this
standard;
− “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard;
− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
- 3 - EN 60601-1:2006
An asterisk (* ) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex A.
Annexes ZA and ZZ have been added by CENELEC.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60073 NOTE Harmonized as EN 60073:2002 (not modified).
IEC 60086-1 NOTE Harmonized as EN 60086-1:2001 (not modified).
IEC 60127-6 NOTE Harmonized as EN 60127-6:1994 (not modified).
IEC 60309-1 NOTE Harmonized as EN 60309-1:1999 (not modified).
IEC 60317-43 NOTE Harmonized as EN 60317-43:1997 (not modified).
IEC 60601-1-1 NOTE Harmonized as EN 60601-1-1:2001 (not modified).
IEC 60601-1-4 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).
IEC 60601-2-49 NOTE Harmonized as EN 60601-2-49:2001 (not modified).
IEC 60695-1-1 NOTE Harmonized as EN 60695-1-1:2000 (not modified).
IEC 60721 series NOTE Harmonized in EN 60721 series (not modified).
IEC 60990 NOTE Harmonized as EN 60990:1999 (not modified).
IEC 61000-4-11 NOTE Harmonized as EN 61000-4-11:2004 (not modified).
IEC 61010-1 NOTE Harmonized as EN 61010-1:2001 (not modified).
IEC 61140 NOTE Harmonized as EN 61140:2002 (not modified).
IEC 62079 NOTE Harmonized as EN 62079:2001 (not modified).
IEC 62304 NOTE Harmonized as EN 62304:2006 (not modified).
ISO 407 NOTE Harmonized as EN ISO 13407:2004 (not modified).
ISO 8041 NOTE Harmonized as EN ISO 8041:2005 (not modified).
ISO 13485 NOTE Harmonized as EN ISO 13485:2003 (not modified).
__________
Endorsement notice
The text of the International Standard IEC 60601-1:2005 was approved by CENELEC as a European
Standard without any modification.
__________
The contents of the corrigendum of March 2010 have been included in this copy.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.
Publication Year Title EN/HD Year
IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus EN 60065 2002
- Safety requirements + corr. March 2006
1)
IEC 60068-2-2 1974 Environmental testing EN 60068-2-2 1993
A1 1993 Part 2: Tests - Tests B: Dry heat A1 1993
A2 1994 A2 1994
2) 3)
IEC 60079-0 - Electrical apparatus for explosive gas EN 60079-0 2006
(mod) atmospheres
Part 0: General requirements
2) 3)
IEC 60079-2 - Electrical apparatus for explosive gas EN 60079-2 2004
atmospheres + corr. April 2006
Part 2: Pressurized enclosures "p"
2)
IEC 60079-5 - Electrical apparatus for explosive gas -
atmospheres -
Part 5: Powder filling 'q'
2)
IEC 60079-6 - Electrical apparatus for explosive gas - -
atmospheres
Part 6: Oil-immersion "o"
2)
IEC 60083 - Plugs and socket-outlets for domestic and -
-
similar general use standardized in member
countries of IEC
2) 3)
IEC 60085 - Electrical insulation - Thermal classification EN 60085 2004
2) 3)
IEC 60086-4 - Primary batteries EN 60086-4 2000
Part 4: Safety of lithium batteries
2) 3)
IEC 60112 - Method for the determination of the proof EN 60112 2003
and the comparative tracking indices of solid
insulating materials
IEC 60127-1 2006 Miniature fuses EN 60127-1 2006
Part 1: Definitions for miniature fuses and
general requirements for miniature fuse-links
4)
IEC 60227-1 1993 Polyvinyl chloride insulated cables of rated - -
A1 1995 voltages up to and including 450/750 V - -
A2 1998 Part 1: General requirements - -
1)
EN 60068-2-2 includes supplement A:1976 to IEC 60068-2-2.
2)
Undated reference.
3)
Valid edition at date of issue.
4)
HD 21.1 S4:2002, Cables of rated voltages up to and including 450/750 V and having thermoplastic insulation -
Part 1: General requirements, which is related to, but not directly equivalent with, IEC 60227-1, applies instead.
- 5 - EN 60601-1:2006
Publication Year Title EN/HD Year
5)
IEC 60245-1 2003 Rubber insulated cables - Rated voltages up - -
to and including 450/750 V
Part 1: General requirements
2) 3)
IEC 60252-1 - AC motor capacitors EN 60252-1 2001
Part 1: General - Performance, testing and
rating - Safety requirements - Guide for
installation and operation
2) 3)
IEC 60320-1 - Appliance couplers for household and similar EN 60320-1 2001
general purposes
Part 1: General requirements
IEC 60335-1 (mod) 2001 Household and similar electrical appliances - EN 60335-1 2002
Safety A11 2004
Part 1: General requirements A12 2006
+ corr. July 2006
IEC 60364-4-41 2005 Low-voltage electrical installations HD 60364-4-41 2006
(mod) Part 4-41: Protection for safety - Protection
against electric shock
IEC 60384-14 2005 Fixed capacitors for use in electronic EN 60384-14 2005
equipment
Part 14: Sectional specification - Fixed
capacitors for electromagnetic interference
suppression and connection to the supply
mains
IEC 60417 Data Graphical symbols for use on equipment -
base -
2) 3)
IEC 60445 - Basic and safety principles for man-machine EN 60445 2000
interface, marking and identification -
Identification of equipment terminals and of
terminations of certain designated
conductors, including general rules for an
alphanumeric system
2) 3)
IEC 60447 - Basic and safety principles for man-machine EN 60447 2004
interface, marking and identification -
Actuating principles
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code) + corr. May 1993
A1 1999 A1 2000
2) 3)
IEC 60601-1-2 - Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests
2) 3)
IEC 60601-1-3 - Medical electrical equipment EN 60601-1-3 1994
Part 1: General requirements for safety - 3.
Collateral standard: General requirements
for radiation protection in diagnostic X-ray
equipment
2) 3)
IEC 60601-1-6 - Medical electrical equipment EN 60601-1-6 2004
Part 1-6: General requirements for safety -
Collateral standard: Usability
5)
HD 22.1 S4:2002, Cables of rated voltages up to and including 450/750 V and having cross-linked insulation - Part 1:
General requirements, which is related to, but not directly equivalent with, IEC 60245-1, applies instead.
Publication Year Title EN/HD Year
2) 3)
IEC 60601-1-8 - Medical electrical equipment EN 60601-1-8 2004
Part 1-8: General requirements for safety - + corr. October 2006
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
IEC 60664-1 (mod) 1992 Insulation coordination for equipment within
+ A1 2000 low-voltage systems
+ A2 2002 Part 1: Principles, requirements and tests EN 60664-1 2003
2) 3)
IEC 60695-11-10 - Fire hazard testing EN 60695-11-10 1999
Part 11-10: Test flames - 50 W horizontal
and vertical flame test methods
IEC 60730-1 (mod) 1999 Automatic electrical controls for household EN 60730-1 2000
and similar use A12 2003
A1 (mod) 2003 Part 1: General requirements A1 2004
A13 2004
A14 2005
IEC 60825-1 1993 Safety of laser products EN 60825-1 1994
Part 1: Equipment classification, + corr. February 1995
A1 1997 requirements and user's guide A1 2002
A2 2001 A2 2001
+ corr. April 2004
IEC 60851-3 1996 Winding wires - Test methods EN 60851-3 1996
A1 1997 Part 3: Mechanical properties A1 1997
A2 2003 A2 2003
IEC 60851-5 1996 Winding wires - Test methods EN 60851-5 1996
A1 1997 Part 5: Electrical properties A1 1997
A2 2004 A2 2004
IEC 60851-6 1996 Winding wires - Test methods EN 60851-6 1996
A1 1997 Part 6: Thermal properties A1 1997
IEC/TR 60878
...
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