SIST EN 60601-1:2007/A1:2014
(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
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1. 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.
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
Le contenu du corrigendum de juillet 2014 a été pris en considération dans cet exemplaire.
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Dopolnilo A1
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
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-1:2007/A1:2014
01-januar-2014
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SIST EN 60601-1:2007/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
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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/A1:2013
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 60601-1:2007/A1:2014
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SIST EN 60601-1:2007/A1:2014
EUROPEAN STANDARD
EN 60601-1/A1
NORME EUROPÉENNE
October 2013
EUROPÄISCHE NORM
ICS 11.040
English version
Medical electrical equipment -
Part 1: General requirements for basic safety and essential performance
(IEC 60601-1:2005/A1:2012)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 1: Exigences générales pour la Teil 1: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles Leistungsmerkmale
(CEI 60601-1:2005/A1:2012) (IEC 60601-1:2005/A1:2012)
This amendment A1 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on
2013-09-24. 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.
CENELEC
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
© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1:2006/A1:2013 E
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SIST EN 60601-1:2007/A1:2014
EN 60601-1:2006/A1:2013 - 2 -
Foreword
The text of document 62A/805/FDIS, future IEC 60601-1:2005/A1, 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 approved by CENELEC as
EN 60601-1:2006/A1:2013.
The following dates are fixed:
• latest date by which the document has
(dop) 2014-06-24
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national
(dow) 2018-12-24
standards conflicting with the
document have to be withdrawn
In the foreword of EN 60601-1:2006, replace the first sentence of the third paragraph by:
This European Standard supersedes EN 60601-1:1990 and its amendments, EN 60601-1-1:2001 and
EN 60601-1-4:1996 + A1:1999.
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 Annex ZZ, which is an integral part of this
document.
Endorsement notice
The text of the International Standard IEC 60601-1:2005/A1:2012 was approved by CENELEC as a
European Standard without any modification.
Replace the Bibliography of EN 60601-1:2006 by:
IEC 60073 NOTE Harmonized as EN 60073.
IEC 60086-1 NOTE Harmonized as EN 60086-1.
IEC 60127-6 NOTE Harmonized as EN 60127-6.
IEC 60309-1 NOTE Harmonized as EN 60309-1.
IEC 60332-1-2 NOTE Harmonized as EN 60332-1-2.
IEC 60332-2-2 NOTE Harmonized as EN 60332-2-2.
IEC 60317-43 NOTE Harmonized as EN 60317-43.
IEC 60601-1-1:2000 NOTE Harmonized as EN 60601-1-1:2001 (not modified).
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).
IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.
IEC 60601-2-22 NOTE Harmonized as EN 60601-2-22.
IEC 60601-2-49:2001 NOTE Harmonized as EN 60601-2-49:2001 (not modified).
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IEC 60695-1-10 NOTE Harmonized as EN 60695-1-10.
IEC 60721 series NOTE Harmonized in EN 60721 series.
IEC 60990 NOTE Harmonized as EN 60990.
IEC 61000-4-11 NOTE Harmonized as EN 61000-4-11.
IEC 61010 series NOTE Harmonized in EN 61010 series.
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010 (not modified).
IEC 61140:2001 NOTE Harmonized as EN 61140:2002 (not modified).
IEC 61558-1 NOTE Harmonized as EN 61558-1.
IEC 61558-2-4 NOTE Harmonized as EN 61558-2-4.
IEC 61558-2-23 NOTE Harmonized as EN 61558-2-23.
IEC 62079:2001 NOTE Harmonized as EN 62079:2001 (not modified).
IEC 62353 NOTE Harmonized as EN 62353.
IEC 62471:2006 NOTE Harmonized as EN 62471:2008 (modified).
IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011 (not modified).
ISO 407 NOTE Harmonized as EN ISO 13407.
ISO 7396-1 NOTE Harmonized as EN ISO 7396-1.
ISO 8041 NOTE Harmonized as EN ISO 8041.
ISO 13485 NOTE Harmonized as EN ISO 13485.
ISO 15001 NOTE Harmonized as EN ISO 15001.
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EN 60601-1:2006/A1:2013 - 4 -
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. 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.
Replace Annex ZA of EN 60601-1:2006 by :
Publication Year Title EN/HD Year
IEC 60065 (mod) 2001 Audio, video and similar electronic apparatus EN 60065 2002
+ corr. August 2002 - Safety requirements + corr. August 2007
+ A1 (mod) 2005 + A1 2006
+ A2 (mod) 2010 + A2 2010
+ A11 2008
+ A12 2011
IEC 60068-2-2 2007 Environmental testing - EN 60068-2-2 2007
Part 2-2: Tests - Test B: Dry heat
IEC 60079-0 - Explosive atmospheres - EN 60079-0 -
Part 0: Equipment - General requirements
IEC 60079-2 - Explosive atmospheres - EN 60079-2 -
Part 2: Equipment protection by pressurized
enclosure "p"
IEC 60079-5 - Explosive atmospheres - EN 60079-5 -
Part 5: Equipment protection by powder
filling "q"
IEC 60079-6 - Explosive atmospheres - EN 60079-6 2007
Part 6: Equipment protection by oil
immersion "o"
IEC 60083 - Plugs and socket-outlets for domestic and - -
similar general use standardized in member
countries of IEC
IEC 60085 - Electrical insulation - Thermal evaluation and EN 60085 -
designation
IEC 60086-4 - Primary batteries - EN 60086-4 -
Part 4: Safety of lithium batteries
IEC 60112 - Method for the determination of the proof EN 60112 -
and the comparative tracking indices of solid
insulating materials
IEC 60127-1 - Miniature fuses - EN 60127-1 -
Part 1: Definitions for miniature fuses and
general requirements for miniature fuse-links
IEC 60227-1 2007 Polyvinyl chloride insulated cables of rated - -
voltages up to and including 450/750 V -
Part 1: General requirements
IEC 60245-1 2003 Rubber insulated cables - Rated voltages up - -
+ A1 2007 to and including 450/750 V -
Part 1: General requirements
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Publication Year Title EN/HD Year
IEC 60252-1 - AC motor capacitors - EN 60252-1 -
Part 1: General - Performance, testing and
rating - Safety requirements - Guidance for
installation and operation
IEC 60320-1 - Appliance couplers for household and similar EN 60320-1 -
general purposes -
Part 1: General requirements
IEC 60335-1 (mod) 2010 Household and similar electrical appliances - EN 60335-1 2012
+ corr. July 2010 Safety -
+ corr. April 2011 Part 1: General requirements
IEC 60364-4-41 - Low-voltage electrical installations - HD 60364-4-41 -
Part 4-41: Protection for safety - Protection
against electric shock
1)
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 Graphical symbols for use on equipment - -
Data-
base
IEC 60445 - Basic and safety principles for man-machine EN 60445 -
interface, marking and identification -
Identification of equipment terminals,
conductor terminations and conductors
IEC 60447 - Basic and safety principles for man-machine EN 60447 -
interface, marking and identification -
Actuating principles
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
+ A1 1999 enclosures (IP Code) + corr. May 1993
+ A1 2000
IEC 60601-1-2 - Medical electrical equipment - EN 60601-1-2 -
Part 1-2: General requirements for basic
safety and essential performance - Collateral
standard: Electromagnetic compatibility -
Requirements and tests
IEC 60601-1-3 - Medical electrical equipment - EN 60601-1-3 -
Part 1-3: General requirements for basic
safety and essential performance - Collateral
Standard: Radiation protection in diagnostic
X-ray equipment
IEC 60601-1-6 - Medical electrical equipment - EN 60601-1-6 -
Part 1-6: General requirements for basic
safety and essential performance - Collateral
standard: Usability
1)
EN 60384-14 is superseded by EN 60384-14:2013, which is based on IEC 60384-14:2013.
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EN 60601-1:2006/A1:2013 - 6 -
Publication Year Title EN/HD Year
IEC 60601-1-8 - Medical electrical equipment - EN 60601-1-8 -
Part 1-8: General requirements for basic
safety and essential performance - Collateral
Standard: General requirements, tests and
guidance for alarm systems in medical
electrical equipment and medical electrical
systems
IEC 60664-1 2007 Insulation coordination for equipment within EN 60664-1 2007
low-voltage systems -
Part 1: Principles, requirements and tests
IEC 60695-11-10 - Fire hazard testing - EN 60695-11-10 -
Part 11-10: Test flames - 50 W horizontal
and vertical flame test methods
IEC 60730-1 (mod) 2010 Automatic electrical controls for household EN 60730-1 2011
and similar use -
Part 1: General requirements
IEC 60825-1 2007 Safety of laser products - EN 60825-1 2007
Part 1: Equipment classification and
requirements
IEC 60851-3 2009 Winding wires - Test methods - EN 60851-3 2009
Part 3: Mechanical properties
IEC 60851-5 2008 Winding wires - Test methods - EN 60851-5 2008
Part 5: Electrical properties
2)
IEC 60851-6 1996 Winding wires - Test methods - EN 60851-6 1996
+ A1 1997 Part 6: Thermal properties + A1 1997
IEC 60884-1 - Plugs and socket-outlets for household and - -
similar purposes -
Part 1: General requirements
3)
IEC 60950-1 (mod) 2001 Information technology equipment - Safety - EN 60950-1 2001
+ corr. October 2002 Part 1: General requirements + corr. December 2007
+ A11 2004
4)
IEC 61058-1 (mod) 2000 Switches for appliances - EN 61058-1 2002
+ corr. January 2009 Part 1: General requirements + A2 2008
+ A1 2001
+ A2 2007
IEC 61558-2-1 - Safety of power transformers, power EN 61558-2-1 -
supplies, reactors and similar products -
Part 2-1: Particular requirements and tests
for separating transformers and power
supplies incorporating separating
transformers for general applications
IEC 61672-1 - Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
IEC 61672-2 - Electroacoustics - Sound level meters - EN 61672-2 -
Part 2: Pattern evaluation tests
IEC 61965 - Mechanical safety of cathode ray tubes EN 61965 -
2)
EN 60851-6 is superseded by EN 60851-6:2012, which is based on IEC 60851-6:2012.
3)
EN 60950-1 is superseded by EN 60950-1:2006, which is based on IEC 60950-1:2005.
4)
EN 61058-1 includes A1 to IEC 61058-1 (mod) + corr. January .
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Publication Year Title EN/HD Year
IEC 62133 - Secondary cells and batteries containing EN 62133 -
alkaline or other non-acid electrolytes -
Safety requirements for portable sealed
secondary cells, and for batteries made from
them, for use in portable applications
IEC 62304 2006 Medical device software - Software life-cycle EN 62304 2006
processes + corr. November 2008
ISO 780 - Packaging - Pictorial marking for handling of EN ISO 780 -
goods
ISO 1853 - Conducting and dissipative rubbers, - -
vulcanized or thermoplastic - Measurement
of resistivity
ISO 2878 - Rubber, vulcanized - Antistatic and - -
conductive products - Determination of
electrical resistance
ISO 2882 - Rubber, vulcanized - Antistatic and - -
conductive products for hospital use -
Electrical resistance limits
ISO 3746 - Acoustics - Determination of sound power EN ISO 3746 -
levels and sound energy 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
ISO 5349-1 - Mechanical vibration - Measurement and EN ISO 5349-1 -
evaluation of human exposure to hand-
transmitted vibration -
Part 1: General requirements
ISO 7000 2004 Graphical symbols for use on equipment - - -
Index and synopsis
ISO 7010 2011 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs
ISO 9614-1 - Acoustics - Determination of sound power EN ISO 9614-1 -
levels of noise sources using sound intensity
-
Part 1: Measurement at discrete points
ISO 10993 series Biological evaluation of medical devices EN ISO 10993 series
ISO 11135-1 2007 Sterilization of health care products - EN ISO 11135-1 2007
Ethylene oxide -
Part 1: Requirements for development,
validation and routine control of a
sterilization process for medical devices
ISO 11137-1 2006 Sterilization of health care products - EN ISO 11137-1 2006
Radiation -
Part 1: Requirements for development,
validation and routine control of a
sterilization process for medical devices
ISO 13857 2008 Safety of machinery - Safety distances to EN ISO 13857 2008
prevent hazard zones being reached by
upper and lower limbs
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Publication Year Title EN/HD Year
ISO 14971 2007 Medical devices - Application of risk EN ISO 14971 2012
management to medical devices
ISO 15223-1 2012 Medical devices - Symbols to be used with EN ISO 15223-1 2012
medical device labels, labelling and
information to be supplied -
Part 1: General requirements
ISO 17665-1 2006 Sterilization of health care products - Moist EN 17665-1 2006
heat -
Part 1: Requirements for the development,
validation and routine control of a
sterilization process for medical devices
ISO 23529 - Rubber - General procedures for preparing - -
and conditioning test pieces for physical test
methods
ISO 80000-1 2009 Quantities and units - EN ISO 80000-1 2013
Part 1: General
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Annex ZZ
(informative)
Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC on 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 93/42/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 ZZ.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 5. 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 ZZ.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 MDD (Directive 93/42/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 ZZ 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.
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EN 60601-1:2006/A1:2013 - 10 -
Table ZZ.1: Relationship between Essential Requirements of Directive 93/42/EEC amended by
2007/47/EC, and Clauses and Subclauses of this standard
No. Essential Requirement Coverage
I.
1. General Guidance note 2 and 3 shall be observed
1 Not completely covered
The devices must be designed and
manufactured in such a way that, when
But If the manufacturer follows this standard in his
used under the conditions and for the
design and manufacturing process, this European
purposes intended, they will not
Standard gives a valuable set of technical
compromise the clinical condition or the
requirements to assist in fulfilling this ER for
safety of patients, or the safety and
equipment in the scope of this standard.
health of users or, where applicable,
other persons, provided that any risks
which may be associated with their
intended use constitute acceptable risks
when weighed against the benefits to
the patient and are compatible with a
high level of protection of health and
safety.
This shall include:
Not covered
- reducing, as far as possible, the risk
See EN/IEC 60601-1-6, EN/IEC 62366,
of use error due to the ergonomic
EN/IEC 60601-1-11 and
features of the device and the
EN/IEC 60601-1-12
environment in which the device is
intended to be used (design for
patient safety), and
- consideration of the technical Covered only for accompanying documents by:
knowledge, experience, education
7.9.1 Paragraphs 4 and 5, intended operator
and training and where applicable
the medical and physical conditions
of intended users (design for lay,
professional, disabled or other
users).
2. General Guidance note 2 and 3 shall be observed
st
1 paragraph:
2 The solutions adopted by the
Covered only in respect of the following and under
manufacturer for the design and
nd
the condition that 2 paragraph (including the
construction of the devices must
following 3 bullets) is taken into account:
conform to safety principles, taking
8 Protection against electrical hazards from ME
account of the generally acknowledged
equipment
state of the art.
9 Protection against mechanical hazards of ME
equipment and ME systems
In selecting the most appropriate
15 Construction of me equipment
solutions, the manufacturer must apply
nd
the following principles in the following
2 paragraph (including the following 3 bullets)
order:
Not covered in the normative text.
- eliminate or reduce risks as far as
possible (inherently safe design and
construction),
- where appropriate take adequate
protection measures including
alarms if necessary, in relation to
risks that cannot be eliminated,
- inform users of the residual risks
due to any shortcomings of the
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No. Essential Requirement Coverage
protection measures adopted.
Not covered
3 The devices must achieve the
performances intended by the
manufacturer and be designed,
manufactured and packaged 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 the
manufacturer.
Not covered
4 The characteristics and performances
However, the standard provides a procedure for the
referred to in Sections 1, 2 and 3 must
generation of information that is necessary to
not be adversely affected to such a
document that the device is in compliance with this
degree that the clinical conditions and
ER.
safety of the patients and, where
applicable, of other persons are
compromised during the lifetime of the
device as indicated by the
manufacturer, when the device is
subjected to the stresses which can
occur during normal conditions of use.
5. General Guidance note 2 and 3 shall be observed
Covered only in respect of the following:
5 The devices must be designed,
Instructions and information provided by the
manufactured and packed in such a
manufacturer
way that their characteristics and
7.2.17 Marking on protective packaging
performances during their intended use
7.9.3.1 Technical description
will not be adversely affected during
15.3.7 Environmental influences
transport and storage taking account of
the instructions and information
provided by the manufacturer.
6. General Guidance note 2 and 3 shall be observed
Not covered.
6 Any undesirable side-effect must
constitute an acceptable risk when
weighed against the performances
intended.
Not covered
6a Demonstration of conformity with the
essential requirements must include a
clinical evaluation in accordance with
Annex X.
II.
Chemical, physical and biological General Guidance note 2 and 3 shall be observed
7
properties
The devices must be designed and Not covered
7.1
manufactured in such a way as to
guarantee the characteristics and
performances referred to in Section I (3)
on the ‘General requirements’.
Particular attention must be paid to:
- the choice of materials used, Partially covered in respect of the following:
particularly as regards toxicity and,
Toxicity:
where appropriate, flammability,
11.7 Biocompatibility, the manufacturer should apply
the appropriate part of the EN ISO 10993 series
13.1.2 Emissions, deformation of Enclosure or
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EN 60601-1:2006/A1:2013 - 12 -
No. Essential Requirement Coverage
exceeding maximum temperature
Flammability:
11.2 Fire prevention
11.3 Constructional requirements for fire enclosures
11.4 ME equipment and ME systems intended for
use with flammable
anaesthetics
Annex G Protection against hazards of ignition of
flammable anaesthetic
mixtures
Not covered
- the compatibility between the
materials used and biological
The manufacturer should apply the appropriate part
tissues, cells and body fluids, taking
of the EN ISO 10993 series
account of the intended purpose of
the device,
- where appropriate, the results of Not covered
biophysical or modeling research
whose validity has been
demonstrated beforehand.
The devices must be designed, Not covered
7.2
manufactured and packed in such a
way as to minimize the risks posed by
contaminants and residues to the
persons involved in the transport,
storage and use of the devices and to
the patients, taking account of the
intended purpose of the product.
Particular attention must be paid to the
tissues exposed and to the duration and
frequency of exposure.
The devices must be designed and Covered only for the physical properties dealt with in
7.3
manufactured in such a way that they Subclauses:
can be used safely with the materials, 11.2.2 ME equipment and ME systems used in
substances and gases with which they conjunction with oxygen rich environments
enter into contact during their normal 11.2.3 Single fault conditions related to oxygen rich
use or during routine procedures; environments
and 11.6.1, 11.6.2, 11.6.3, 11.6.4, 11.6.6, 11.6.7,
11.6.8 (Overflow, spillage, leakage, cleaning,
disinfection, sterilization and compatibility with
substances used)
if the devices are intended to administer Not covered
medicinal products they must be
designed and manufactured in such a
way as to be compatible with the
medicinal products concerned
according to the provisions and
restrictions governing these products
and that their performance is
maintained in accordance with the
intended use.
Not covered
7.4 Where a device incorporates, as an
integral part, a substance which, if used
separately, may be considered to be a
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No. Essential Requirement Coverage
medicinal product as defined in Article 1
of Directive 2001/83/EC and which is
liable to act upon the body with action
ancillary to that of the device, the
quality, safety and usefulness of the
substance must be verified by analogy
with the methods specified in Annex I to
Directive 2001/83/EC.
Not covered
For the substances referred to in the
first paragraph, the notified body shall,
having verified the usefulness of the
substance as part of the medical device
and taking account of the intended
purpose of the device, seek a scientific
opinion from one of the competent
authorities designated by the Member
States or the European Medicines
Agency (EMEA) acting particularly
through its committee in accordance
with Regulation (EC) No 726/2004 on
the quality and safety of the substance
including the clinical benefit/risk profile
of the incorporation of the substance
into the device. When issuing its
opinion, the competent authority or the
EMEA shall take into account the
manufacturing process and the data
related to the usefulness of
incorporation of the substance into the
device as determined by the notified
body.
Where a device incorporates, as an
integral part, a human blood derivative,
the notified body shall, having verified
the usefulness of the substance as part
of the medical device and taking into
account the intended purpose of the
device, seek a scientific opinion from
the EMEA, acting particularly through its
committee, on the quality and safety of
the substance including the clinical
benefit/risk profile of the incorporation of
the human blood derivative into the
device. When issuing its opinion, the
EMEA shall take into account the
manufacturing process and the data
related to the usefulness of
incorporation of the substance into the
device as determined by the notified
body.
Where changes are made to an
...
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