SIST EN 60601-1:2007

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.

General Information

• Status: Published
• Publication Date: 28-Feb-2007
• Withdrawal Date: 28-Feb-2007
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Mar-2007
• Due Date: 01-Mar-2007
• Completion Date: 01-Mar-2007
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: TRRTP129 - Tehnična smernica TSG-12640-001:2008 Zdravstveni objekti
• 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

• Replaces: SIST EN 60601-1:1995 - Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:1991)
• Effective Date: 28-Jan-2023
• Replaces: SIST EN 60601-1:1995 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 07-Jun-2022
• Replaces: SIST EN 60601-1:1995/A2:1998 - Medical electrical equipment -- Part 1: General requirements for safety
• Effective Date: 01-Mar-2007
• Replaces: SIST EN 60601-1:1995 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 01-Mar-2007
• Replaces: SIST EN 60601-1-4:1998/A1:2002 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1998)
• Effective Date: 01-Mar-2007
• Replaces: SIST EN 60601-1:1995/A13:1998 - Medical electrical equipment -- Part 1: General requirements for safety
• Effective Date: 01-Mar-2007
• Replaces: SIST EN 60601-1-1:2002 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000)
• Effective Date: 01-Mar-2007
• Replaces: SIST EN 60601-1-4:1998 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996)
• Effective Date: 01-Mar-2007
• Amended By: SIST EN 60601-1:2007/A13:2024 - Medical electrical equipment - Part 1: General requirements for safety
• Effective Date: 01-Jun-2024
• Amended By: SIST EN 60601-1:2007/A2:2021 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
• Effective Date: 29-Aug-2017
• Amended By: SIST EN 60601-1:2007/A12:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Dec-2014
• Amended By: SIST EN 60601-1:2007/A1:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Jan-2014
• Amended By: SIST EN 60601-1:2007/A11:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Jan-2012
• Corrected By: SIST EN 60601-1:2007/AC:2023 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/COR3:2022)
• Effective Date: 01-Feb-2023
• Corrected By: SIST EN 60601-1:2007/AC:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 01-Jul-2014

Overview

EN 60601-1:2006 (European adoption of IEC 60601-1:2005, 3rd edition) is the primary European standard setting general requirements for basic safety and essential performance of medical electrical (ME) equipment. It defines mandatory design and test requirements that apply across a wide range of devices and systems. Where device‑specific (particular) or collateral standards exist, EN 60601-1 must be used together with those standards - it is not intended to be the sole standard for all medical electrical products. This edition introduced a formal risk management process requirement and further aligned electrical safety clauses with information‑technology safety standards (e.g., EN 60950‑1).

Key topics and requirements

• Basic safety and essential performance: Requirements to ensure that the device does not cause unacceptable risks under normal use and single‑fault conditions.
• Risk management: Obligation to include a documented risk management process as part of design and verification activities.
• Electrical safety and insulation: Protection against electric shock, including requirements for insulation, creepage/clearance practices and earthing arrangements (aligned with IT equipment principles).
• Usability and human factors: Design considerations to reduce user errors (see collateral usability standard).
• Electromagnetic compatibility (EMC): General EMC expectations; detailed EMC testing and limits are covered in the collateral standard EN 60601‑1‑2.
• Documentation and labelling: Requirements for instructions for use, warnings, marking and graphical symbols.
• Conformity and regulatory mapping: Annexes mapping essential requirements relevant to EC Directives (e.g., 93/42/EEC, 90/385/EEC).

(Note: EN 60601‑1 is structured with normative clauses, informative annexes and cross‑references to many normative publications; specific test procedures and numeric limits are found in the standard text and its collateral/particular standards.)

Applications

EN 60601-1 is used to:

• Guide design and verification of new medical electrical devices and systems.
• Support conformity assessment and technical documentation for CE marking.
• Define requirements for safety and essential performance in risk management files.
• Establish test protocols for independent test labs and notified bodies.

Who uses this standard

• Medical device manufacturers and design engineers
• Regulatory and compliance teams preparing CE technical files
• Test laboratories and notified bodies performing conformity assessment
• Quality managers, risk managers and procurement specialists in healthcare

Related standards

• EN/IEC 60601‑1‑2 (EMC)
• EN/IEC 60601‑1‑6 (Usability)
• EN/IEC 60601‑1‑3 (Radiation protection in diagnostic X‑ray)
• EN/IEC 60601‑1‑8 (Alarm systems)
• Particular/part 2 standards (EN 60601‑2‑xx) for specific device types

Keywords: EN 60601-1:2006, IEC 60601-1, medical electrical equipment, basic safety, essential performance, risk management, CE marking, EMC, usability, medical device compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2007
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SIST EN 60601-1:1995
SIST EN 60601-1:1995/A13:1998
SIST EN 60601-1:1995/A2:1998
SIST EN 60601-1-1:2002
SIST EN 60601-1-4:1998
SIST EN 60601-1-4:1998/A1:2002
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ELVWYHQH]PRJOMLYRVWL,(&
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 2003 Graphical symbols for electrical equipment in - -
medical practice
2)
IEC 60884-1 - Plugs and socket-outlets for household and - -
similar purposes
Part 1: General requirements
6)
IEC 60950-1 (mod) 2001 Information technology equipment - Safety EN 60950-1 2001
Part 1: General requirements + corr. April 2004
A11 2004
IEC 61058-1 (mod) 2000 Switches for appliances
+ A1 2001 Part 1: General requirements EN 61058-1 2002

7)
IEC 61558-1 (mod) 1997 Safety of power transformers, power supply EN 61558-1 1997
units and similar + corr. April 2003
A1 1998 Part 1: General requirements and tests A1 1998

A11 2003
2) 3)
IEC 61558-2-1 - Safety of power transformers, power supply EN 61558-2-1 1997
units and similar
Part 2-1: Particular requirements for
separating transformers for general use

2) 3)
IEC 61672-1 - Electroacoustics - Sound level meters EN 61672-1 2003
Part 1: Specifications
6)
EN 60950-1 is superseded by EN 60950-1:2006, which is based on IEC 60950-1:2005, mod.
7)
EN 61558-1 is superseded by EN 61558-1:2005, which is based on IEC 61558-1:2005.

- 7 - EN 60601-1:2006
Publication Year Title EN/HD Year
2) 3)
IEC 61672-2 - Electroacoustics - Sound level meters EN 61672-2 2003
Part 2: Pattern evaluation tests

2) 3)
IEC 61965 - Mechanical safety of cathode ray tubes EN 61965 2003

ISO 31 Series Quantities and units of space and time - -

2)
ISO 780 - Packaging - Pictorial marking for handling of EN ISO 780 1999
goods
2)
ISO 1000 - SI units and recommendations for the use of - -
their multiples and of certain other units

2)
ISO 1853 - Conducting and dissipative rubbers, - -
vulcanized or thermoplastic - Measurement
of resistivity
2)
ISO 2878 - Rubber, vulcanized - Antistatic and - -
conductive products - Determination of
electrical resistance
2)
ISO 2882 - Rubber, vulcanized - Antistatic and - -
conductive products for hospital use -
Electrical resistance limits
2)
ISO 3746 - Acoustics - Determination of sound power EN ISO 3746 1995
levels of noise sources using sound
pressure - Survey method using an
enveloping measurement surface over a
reflecting plane
ISO 3864-1 2002 Graphical symbols - Safety colours and - -
safety signs
Part 1: Design principles for safety signs in
workplaces and public areas
__________
Annex ZZ
(informative)
Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directives 90/385/EEC and 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directives concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling
within the scope of this standard.
__________
INTERNATIONAL IEC
STANDARD 60601-1
Third edition
2005-12
Medical electrical equipment –
Part 1:
General requirements for basic safety
and essential performance
© IEC 2005 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,
including photocopying and microfilm, without permission in writing from the publisher.
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XN
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
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60601-1  IEC:2005 – 3 –
CONTENTS
FOREWORD.21
INTRODUCTION.25

1 Scope, object and related standards.29
1.1 * Scope .29
1.2 Object .29
1.3 * Collateral standards.29
1.4 * Particular standards.31
2 * Normative references.31
3 * Terminology and definitions .39
4 General requirements .79
4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS.79
4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS .79
4.3 * ESSENTIAL PERFORMANCE .81
4.4 * EXPECTED SERVICE LIFE .81
4.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS .83
4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT .83
4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT.83
4.8 Components of ME EQUIPMENT .85
4.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT .85
4.10 * Power supply .87
4.11 Power input .89
5 * General requirements for testing ME EQUIPMENT .91
5.1 * TYPE TESTS.91
5.2 * Number of samples .91
5.3 Ambient temperature, humidity, atmospheric pressure.91
5.4 Other conditions .91
5.5 Supply voltages, type of current, nature of supply, frequency .93
5.6 Repairs and modifications .93
5.7 * Humidity preconditioning treatment .93
5.8 Sequence of tests .95
5.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS .95
6 * Classification of ME EQUIPMENT and ME SYSTEMS.99
6.1 General .99
6.2 * Protection against electric shock.99
6.3 * Protection against harmful ingress of water or particulate matter .101
6.4 Method(s) of sterilization .101
6.5 Suitability for use in an OXYGEN RICH ENVIRONMENT .101
6.6 * Mode of operation .101

60601-1  IEC:2005 – 5 –
7 ME EQUIPMENT identification, marking and documents .101
7.1 General .101
7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts .105
7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts .113
7.4 Marking of controls and instruments .117
7.5 Safety signs .119
7.6 Symbols .121
7.7 Colours of the insulation of conductors.121
7.8 * Indicator lights and controls .123
7.9 ACCOMPANYING DOCUMENTS.123
8 * Protection against electrical HAZARDS from ME EQUIPMENT.135
8.1 Fundamental rule of protection against electric shock.135
8.2 Requirements related to power sources.137
8.3 Classification of APPLIED PARTS .137
8.4 Limitation of voltage, current or energy.139
8.5 Separation of parts.145
8.6 * Protective earthing, functional earthing and potential equalization of
ME EQUIPMENT.161
8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS .167
8.8 Insulation .201
8.9 * CREEPAGE DISTANCES and AIR CLEARANCES.213
8.10 Components and wiring .243
8.11 MAINS PARTS, components and layout .247
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS .259
9.1 MECHANICAL HAZARDS of ME EQUIPMENT .259
9.2 * HAZARDS associated with moving parts.261
9.3 * HAZARD associated with surfaces, corners and edges.271
9.4 * Instability HAZARDS .271
9.5 * Expelled parts HAZARD .281
9.6 Acoustic energy (including infra- and ultrasound) and vibration .281
9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure.285
9.8 * HAZARDS associated with support systems .291
10 * Protection against unwanted and excessive radiation HAZARDS .301
10.1 X-Radiation .301
10.2 Alpha, beta, gamma, neutron and other particle radiation .303
10.3 Microwave radiation .303
10.4 * Lasers and light emitting diodes (LEDs) .303
10.5 Other visible electromagnetic radiation.303
10.6 Infrared radiation.305
10.7 Ultraviolet radiation .305
11 * Protection against excessive temperatures and other HAZARDS.305
11.1 * Excessive temperatures in ME EQUIPMENT.305
11.2 * Fire prevention.313
11.3 * Constructional requirements for fire ENCLOSURES of ME EQUIPMENT.323

60601-1  IEC:2005 – 7 –
11.4 * ME EQUIPMENT and ME SYSTEMS intended for use with flammable
anaesthetics.329
11.5 * ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
flammable agents .329
11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,
disinfection, sterilization and compatibility with substances used with the
ME EQUIPMENT.329
11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS.333
11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT .333
12 * Accuracy of controls and instruments and protection against hazardous outputs .333
12.1 Accuracy of controls and instruments .333
12.2 USABILITY.333
12.3 Alarm systems.333
12.4 Protection against hazardous output.333
13 * HAZARDOUS SITUATIONS and fault conditions.337
13.1 Specific HAZARDOUS SITUATIONS .337
13.2 SINGLE FAULT CONDITIONS .339
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .351
14.1 * General.351
14.2 * Documentation.351
14.3 * RISK MANAGEMENT plan .353
14.4 * PEMS DEVELOPMENT LIFE-CYCLE .353
14.5 * Problem resolution .353
14.6 RISK MANAGEMENT PROCESS.353
14.7 * Requirement specification .355
14.8 * Architecture .355
14.9 * Design and implementation.357
14.10 * VERIFICATION .357
14.11 * PEMS VALIDATION .357
14.12 * Modification .359
14.13 * Connection of PEMS by NETWORK/DATA COUPLING to other equipment .359
15 Construction of ME EQUIPMENT .359
15.1 * Arrangements of controls and indicators of ME EQUIPMENT.359
15.2 * Serviceability .359
15.3 Mechanical strength .361
15.4 ME EQUIPMENT components and general assembly.369
15.5 * MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing
separation in accordance with 8.5 .379
16 * ME SYSTEMS .387
16.1 * General requirements for the ME SYSTEMS .387
16.2 * ACCOMPANYING DOCUMENTS of an ME SYSTEM .389
16.3 * Power supply .391
16.4 ENCLOSURES .391
16.5 * SEPARATION DEVICES.391
16.6 * LEAKAGE CURRENTS.393
16.7 * Protection against MECHANICAL HAZARDS .395

60601-1  IEC:2005 – 9 –
16.8 Interruption of the power supply to parts of an ME SYSTEM .395
16.9 ME SYSTEM connections and wiring .395
17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .399

Annex A (informative) General guidance and rationale.401
Annex B (informative) Sequence of testing .613
Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS.621
Annex D (informative) Symbols on marking.629
Annex E (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT .647
Annex F (informative) Suitable measuring supply circuits.651
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
mixtures.657
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
documentation .687
Annex I (informative) ME SYSTEMS aspects.713
Annex J (informative) Survey of insulation paths.725
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams .731
Annex L (normative) Insulated winding wires for use without interleaved insulation.737

Bibliography.743

INDEX .749

INDEX OF ABBREVIATIONS AND ACRONYMS .775

Figure 1 – Detachable mains connection.43
Figure 2 – Example of the defined terminals and conductors.45
Figure 3 – Example of a CLASS I ME EQUIPMENT.47
Figure 4 – Example of a metal-enclosed CLASS II ME EQUIPMENT .47
Figure 5 – Schematic flow chart for component qualification .87
Figure 6 – Standard test finger.97
Figure 7 – Test hook.99
Figure 8 – Test pin.141
Figure 9 – Application of test voltage to bridged PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS.155
Figure 10 – Application of test voltage to individual PATIENT CONNECTIONS for
DEFIBRILLATION-PROOF APPLIED PARTS.159
Figure 11 – Application of test voltage to test the delivered defibrillation energy .161

60601-1  IEC:2005 – 11 –
Figure 12 – Example of a measuring device and its frequency characteristics.169
Figure 13 – Measuring circuit for the EARTH LEAKAGE CURRENT of CLASS I ME equipment,
with or without APPLIED PART .175
Figure 14 – Measuring circuit for the TOUCH CURRENT.177
Figure 15 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the PATIENT
CONNECTION to earth.179
Figure 16 – Measuring circuit for the PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) .181
Figure 17 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a SIGNAL INPUT/OUTPUT PART .183
Figure 18 – Measuring circuit for the PATIENT LEAKAGE CURRENT from PATIENT
CONNECTION(S) to earth caused by an external voltage on a metal ACCESSIBLE PART that
is not PROTECTIVELY EARTHED .185
Figure 19 – Measuring circuit for the PATIENT AUXILIARY CURRENT .187
Figure 20 – Measuring circuit for the total PATIENT LEAKAGE CURRENT with all PATIENT
CONNECTIONS of all APPLIED PARTS of the same type (TYPE B APPLIED PARTS, TYPE BF
APPLIED PARTS or TYPE CF APPLIED PARTS) connected together.189
Figure 21 – Ball-pressure test apparatus .213
Figure 22 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 1 .239
Figure 23 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 2 .239
Figure 24 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 3 .239
Figure 25 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 4 .239
Figure 26 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 5 .239
Figure 27 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 6 .241
Figure 28 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 7 .241
Figure 29 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 8 .241
Figure 30 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 9 .241
Figure 31 – CREEPAGE DISTANCE and AIR CLEARANCE – Example 10 .243
Figure 32 – Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE
WORKING PRESSURE .289
Figure 33 – Human body test mass.299
Figure 34 – Spark ignition test apparatus.317
Figure 35 – Maximum allowable current I as a function of the maximum allowable
voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT .317
Figure 36 – Maximum allowable voltage U as a function of the capacitance C
measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT .319
Figure 37 – Maximum allowable current I as a function of the inductance L measured
in an inductive circuit in an OXYGEN RICH ENVIRONMENT .319
Figure 38 – Baffle .327
Figure 39 – Area of the bottom of an ENCLOSURE as specified in 11.3 b) 1) .327
Figure A.1 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in an ECG monitor .413

60601-1  IEC:2005 – 13 –
Figure A.2 – Example of the insulation of an F-TYPE APPLIED PART with the insulation
incorporated in the ME EQUIPMENT .415
Figure A.3 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a PATIENT monitor with invasive pressure monitoring facility .417
Figure A.4 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS
in a multifunction PATIENT monitor with invasive pressure monitoring facilities.419
Figure A.5 – Identification of APPLIED PARTS and PATIENT CONNECTIONS in an X-ray ME
SYSTEM .421
Figure A.6 – Identification of ME EQUIPMENT, APPLIED PARTS and PATIENT CONNECTIONS in
a transcutaneous electronic nerve stimulator (TENS) intended to be worn on the
PATIENT’S belt and connected to electrodes applied to the PATIENT’S upper arm.421
Figure A.7 – Identification of ME EQUIPMENT or ME SYSTEM, APPLIED PARTS and PATIENT
CONNECTIONS in a personal computer with an ECG module .423
Figure A.8 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION and HARM .429
Figure A.9 – Example of PATIENT ENVIRONMENT.441
Figure A.10 – Floating circuit .469
Figure A.11 – Interruption of a power-carrying conductor between ME EQUIPMENT parts
in separate ENCLOSURES.475
Figure A.12 – Identification of MEANS OF PATIENT PROTECTION and MEANS OF OPERATOR
PROTECTION.483
Figure A.13 – Allowable protective earth impedance where the fault current is limited .497
Figure A.14 – Probability of ventricular fibrillation .
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