EN 60601-1:2006/A12:2014
(Amendment)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
2021: CLC legacy converted by DCLab NISOSTS
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
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2014
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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/A12:2014
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 60601-1:2006/A12
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040
English Version
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale
This amendment A12 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2014-09-26. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment 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 CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1:2006/A12:2014 E
Foreword
This document (EN 60601-1:2006/A12:2014) has been prepared by CLC/TC 62 “Electrical equipment
in medical practice”.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2015-03-26
national level by publication of an identical national
standard or by endorsement
(dow) 2015-03-26
• latest date by which the national standards conflicting with
the document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annexes ZZA and ZZB, which are an integral
part of this document.
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In Annex ZZ of EN 60601-1:2006 (available in EN 60601-1:2006/A1:2013), replace "Annex ZZ" by
"Annex ZZA" (two occurences) and "Table ZZ.1" by "Table ZZA.1 (three occurences)".
After Annex ZZA, add the following new Annex:
Annex ZZB
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to the
Essential Requirements given in Annex I of the EC Directives 90/385/EEC as amended by
2007/47/EC.
General Guidance:
Once this standard will be cited in the Official Journal of the European Union under that Directive,
compliance with the clauses of this standard given in Table ZZB.1 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding Essential Requirements
(ERs) of that Directive and associated EFTA regulations.
NOTE 1 This standard is intended to be applied in its entirety only. Selected clauses or subclauses may be not
applicable due to the specific type of equipment under consideration. It is necessary to understand and apply
Clauses 1 to 16. It is also recommended to understand and apply those clauses which contain general
requirements related to a specific subclause. Elements of the standard that are not cited in Table ZZB.1 may be
relevant for the appropriate fulfilment of certain essential requirements through indirect reference, and for safety
and performance aspects of the device, that are not addressed through essential requirements.
NOTE 2 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance to the AIMD (Directive 90/385/EEC amended by 2007/47/EC).
This means that risks have to be reduced "as far as possible", "to a minimum", "to the lowest possible level",
"minimized" or "removed", according to the wording of the corresponding essential requirement.
NOTE 3 With respect to Note 4 of clause 4.2.2 General requirement for risk management, the manufacturer’s
policy for determining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11
and 12 of the directive.
NOTE 4 References in the Clauses 3 to 17 or in the Annexes of this standard specify whether the normative
references listed in Clause 2 as cited in Annex ZA are to be applied in whole or in part.
NOTE 5 This Annex ZZB is based on Normative References according to Annex ZA, replacing the references
in the core text.
WARNING: Other requirements and other EU Directives and Regulations may be applicable to the
product(s) falling within the scope of this standard.
Table ZZB.1 — Relationship between Essential Requirements of Directive 90/385/EEC
amended by 2007/47/EC, and Clauses and Subclauses of this standard
No. Essential Requirement Coverage
I. GENERAL REQUIREMENTS
1. General Guidance notes 2 and 3 shall be observed
1 The devices must be designed and Not covered
manufactured in such a way that, when
This ER relates to the implanted part of the
implanted under the conditions and for the
active implantable medical device.
purposes laid down, their use does not
compromise the clinical condition or the
safety of patients. They must not present any
risk to the persons implanting them or, where
applicable, to other persons.
2 The devices must achieve the performances Not covered.
intended by the manufacturer, viz. be
designed and manufactured in such a way
that they are suitable for one or more of the
functions referred to in Article 1 (2) (a) as
specified by him.
3 The characteristics and performances Not covered.
referred to in sections 1 and 2 must not be
However, the standard provides a procedure
adversely affected to such a degree that the
for the generation of information that is
clinical condition and safety of the patients
necessary to document that the device is in
or, as appropriate, of other persons are
compliance with this ER with regard to the
compromised during the lifetime of the
external parts of an active implantable
device anticipated by the manufacturer,
medical device.
where the device is subjected to stresses
which may occur during normal conditions of
use.
4. General Guidance notes 2 and 3 shall be observed
4 The devices must be designed, Covered for the external part of an active
manufactured and packed in such a way that implantable medical device only in respect
their characteristics and performances are of the following:
not adversely affected in the storage and
7.2.17 Marking on protective packaging
transport conditions laid down by the
7.9.3.1 Technical description
manufacturer (temperature, humidity, etc.).
15.3.7 Environmental influences
5. General Guidance notes 2 and 3 shall be observed
5 Any side effects or undesirable conditions Not covered.
must constitute acceptable risks when
weighed against the performances intended.
5a Demonstration of conformity with the Not covered.
essential requirements must include a clinical
evaluation in accordance with Annex 7.
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No. Essential Requirement Coverage
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
6 The solutions adopted by the manufacturer Covered for the external part of an active
for the design and construction of the implantable medical device only in respect of
devices must comply with safety principles the following:
taking account of the generally
8 Protection against electrical hazards
acknowledged state of the art.
from ME equipment
9 Protection against mechanical hazards
of ME equipment and ME systems
15 Construction of ME equipment
7 Implantable devices must be designed, Not covered.
manufactured and packed in a non-reusable
pack according to appropriate procedures to
ensure they are sterile when placed on the
market and, in the storage and transport
conditions stipulated by the manufacturer,
remain so until the packaging is removed
and they are implanted.
8. General Guidance notes 2 and 3 shall be observed
8 Devices must be designed and manufactured
in such a way as to remove or minimize as
far as possible:
- the risk of physical injury in connection Covered for the external part of an active
with their physical, including dimensional, implantable medical device only in respect of
features, the following:
8.1 Electric shock
9.1 Mechanical Hazards
10 Radiation (all types)
11.1 Excessive temperatures
11.2 Fire prevention
11.4 Flammable anaesthetics
11.5 Flammable agent
11.6.3 Spillage
11.8 Interruption of power supply
12.4 Hazardous output
13.1 Hazardous situations
13.2 Single Fault condition
15.3 Mechanical strength
15.4 Components and general assembly
15.5.3 Construction of transformers
16.3 Power supply
16.5 Separation devices
16.6 Leakage currents
16.8 Interruption of power supply
No. Essential Requirement Coverage
- risks connected with the use of energy Covered for the external part of an active
sources with particular reference, where implantable medical device only in respect of
electricity is used, to insulation, leakage the following:
currents and overheating of the devices,
8.1 Electric shock
13.2 Single Fault condition
15.5.3 Construction of transformers
16.3 Power supply
16.5 Separation devices
16.6 Leakage currents
16.8 Interruption of power supply
- risks connected with reasonably Not covered
foreseeable environmental conditions
See for EMC EN 60601-1-2 as referenced in
such as magnetic fields, external electrical
Annex ZA
influences, electrostatic discharge,
See for acceleration EN 60601-1-11 and
pressure or variations in pressure and
EN 60601-1-12 as referenced in Annex ZA
acceleration,
Covered in respect of the following:
pressure, temperature: test in 5.3 according
to manufacturers' specification in 7.9.3.1
- risks connected with medical treatment, in Covered for the external part of an active
particular those resulting from the use of implantable medical device only in respect of
defibrillators or high-frequency surgical the following:
equipment,
For defibrillator protection
8.5.5 Defibrillation-proof applied parts
- risks connected with ionising radiation Not covered.
from radioactive substances included in
the device, in compliance with the
protection requirements laid down in
Council Directive 96/29/Euratom of
13 May 1996 laying down basic safety
standards for the protection of the health
of workers and the general public against
the dangers arising from ionising radiation
(1) and Council Directive 97/43/Euratom
of 30 June 1997 on health protection of
individuals against the dangers of ionising
radiation in relation to medical
exposure (1),
- risks which may arise where maintenance Not covered.
and calibration are impossible, including:
- excessive increase of leakage
currents,
- ageing of the materials used,
- excess heat generated by the device,
- decreased accuracy of any measuring
or control mechanism.
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No. Essential Requirement Coverage
9 The devices must be designed and
manufactured in such a way as to guarantee
the characteristics and performances
referred to in I. ‘General requirements’, with
particular attention being paid to:
- the choice of materials used, particularly Not covered.
as regards toxicity aspects,
The manufacturer should apply the
appropriate part of EN ISO 10993.
- mutual compatibility between the materials Not covered.
used and biological tissues, cells and
The manufacturer should apply the
body fluids, account being taken of the
appropriate part of EN ISO 10993.
anticipated use of the device,
- compatibility of the devices with the Not covered.
substances they are intended to
administer,
- the quality of the connections, particularly Covered for the external part of an active
in respect of safety, implantable medical device only in respect of
the following:
Covered in respect of the following:
15.4.1 Construction of connectors
- the reliability of the source of energy, No
...
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