SIST EN 60601-2-33:2010/A12:2017

SLOVENSKI STANDARD
01-januar-2017
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Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and
essential performance of magnetic resonance equipment for medical diagnosis
Medizinische elektrische Geräte - Teil 2-33: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Magnetresonanzgeräten für die
medizinische Diagnostik
Appareils électromédicaux - Partie 2-33: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils à résonance magnétique utilisés pour le
diagnostic médical
Ta slovenski standard je istoveten z: EN 60601-2-33:2010/A12:2016
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-33:2010/A12

NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2016
ICS 11.040.55
English Version
Medical electrical equipment - Part 2-33: Particular requirements
for the basic safety and essential performance of magnetic
resonance equipment for medical diagnosis
Appareils électromédicaux - Partie 2-33: Exigences Medizinische elektrische Geräte - Teil 2-33: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils à résonance magnétique utilisés wesentlichen Leistungsmerkmale von
pour le diagnostic médical Magnetresonanzgeräten für die medizinische Diagnostik
This amendment A12 modifies the European Standard EN 60601-2-33:2010; it was approved by CENELEC on 2016-11-01. 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
© 2016 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-33:2010/A12:2016 E

European foreword
This document (EN 60601-2-33:2010/A12:2016) 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) 2017-11-01
national level by publication of an identical national
standard or by endorsement
(dow) 2019-11-01
• 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 Annex ZZ, which is an integral part of this
document.
1 Modifications to annexes
Replace Annex ZA and Annex ZZ with the following.
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.
However, for any use of this standard “within the meaning of Annex ZZ", the user must always check
that any referenced document has not been superseded and that its relevant contents can still be
considered the generally acknowledged state-of-art.
When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a
normative reference to the parallel EN standard, as outlined below, including the foreword and the
Annexes ZZ.
NOTE 1 The way in which referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
NOTE 2 When an international publication has been modified by common modifications, indicated by (mod), the
relevant EN/HD applies.
Publication Year Title EN/HD and IEC/ISO Year
IEC 60601-1 2005 Medical electrical equipment EN 60601-1 2006
Part 1: General requirements for basic
+A1 2012 EN 60601-1/A1 2013
safety and essential performance
EN 60601-1/A1/AC 2014
IEC 60601-1-2 2014 Medical electrical equipment EN 60601-1-2 2015
Part 1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
disturbances - Requirements and tests
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
+A1 2013 EN 60601-1-6/A1 2015
safety and essential performance -
Collateral standard: Usability
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic
+A1 2012 EN 60601-1-8/AC 2010
safety and essential performance -
EN 60601-1-8/A1 2015
Collateral standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
IEC 62570 2014 Standard practice for marking medical EN 62570 2015
devices and other items for safety in the
magnetic resonance environment
Annex ZZ
(informative)
Coverage of Essential Requirements of EU Directives
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 EU Directive 93/42/EEC.
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 The standard’s scope is limited to the specific uses, environments, contexts, objective situations
specifically indicated. It cannot provide for presumption of conformity in other conditions. Some clauses or
subclauses may be not applicable due to the specific type of equipment under consideration.
NOTE 2 Only prescriptions contained in the normative parts of the text are relevant to the presumption of
conformity of this standard. Informative parts may, however, support users to interpret such prescriptions
correctly.
NOTE 3 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 with Directive 93/42/EEC. 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 which must be interpreted and applied in such a way as
to take account of technology and practice existing at the time of design and of technical and economical
considerations compatible with a high level of protection of health and safety.
NOTE 4 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 5 For all parts of this standard that a) refer in their clauses to specific national legislation possibly
exempting manufacturers from the thorough application of relevant provisions of this standard or b) link the
completion of a relevant process/prescription to any discretional choice/power of manufacturers, the user of the
standard should check that such clauses are in compliance with Directive 93/42/EEC.
NOTE 6 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.
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 Requirements Coverage of EN 60601-2-33
I. GENERAL REQUIREMENTS
1. General Guidance notes 1 - 6 shall be observed
1 The devices must be designed and manufactured in If the manufacturer follows this
such a way that, when used under the conditions and standard in his design and
for the purposes intended, they will not compromise the manufacturing process, this
clinical condition or the safety of patients, or the safety European Standard gives a
and health of users or, where applicable, other persons, valuable set of technical
provided that any risks which may be associated with requirements to assist in fulfilling
1)
their intended use constitute acceptable risks when this ER with regard to general
weighed against the benefits to the patient and are X-ray radiation-related aspects of
compatible with a high level of protection of health and the clinical condition or the safety
safety. of patients, or the safety and health
of users or, where applicable, other
This shall include:
persons (refer to Clauses 4 to 13 of
this collateral standard).
- reducing, as far as possible, the risk of use error This European Standard provides
due to the ergonomic features of the device and requirements to minimize risks of
the environment in which the device is intended use error for the following aspects:
to be used (design for patient safety), and
201.12.4.101 Operating modes
201.7.9.2.101 (Instructions for use)
w) About function
201.7.9.3.101 (Technical
Description) a) controlled access
area
- consideration of the technical knowledge, Covered only with respect to
experience, education and training and where 201.7.9.2.101 (Instructions for Use)
applicable the medical and physical conditions p) Recommended training:
of intended users (design for lay, professional, Only to be used by professional
disabled or other users). and licensed users.
2. General Guidance notes 1 - 6 shall be observed
st
2 The solutions adopted by the manufacturer for the 1 paragraph covered under the
nd
design and construction of the devices must conform to condition that 2 paragraph
safety principles, taking account of the generally (including the following 3 bullets) is
acknowledged state of the art. taken into account.
nd
2 paragraph, including the
following 3 bullets, are covered for
In selecting the most appropriate solutions, the
hazardous outputs inherent to MR
manufacturer must apply the following principles in the
equipment, under the condition
following order:
that
- the manufacturer implements
state of the art risk controls as
reflected in 201.4, to 201.17,
- and EN ISO 14971 (2012)
including its Annex ZA.
1) This standard is intended to provide a set of general specifications to be complemented by existing
particular/device specific standards, or by other means, such as risk management.
No. Essential Requirements Coverage of EN 60601-2-33
- 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 protection measures
adopted.
3 The devices must achieve the performances intended MR equipment following the design
by the manufacturer and be designed, manufactured rules set out by this European
and packaged in such a way that they are suitable for Standard is intended for medical
one or more of the functions referred to in Article 1 (2) diagnosis, as called out in Article 1
(a), as specified by the manufacturer. (2) (a).
4 The characteristics and performances referred to in Covered in respect to Quality
Sections 1, 2 and 3 must not be adversely affected to Assurance and Planned
such a degree that the clinical conditions and safety of Maintenance, see
the patients and, where applicable, of other persons are
201.7.9.2.101 Instructions for Use
compromised during the lifetime of the device as
q) quality assurance
indicated by the manufacturer, when the device is
subjected to the stresses which can occur during r) maintenance
normal conditions of use.
5. General Guidance notes 1 - 6 shall be observed
5 The devices must be designed, manufactured and No specific requirements in this
packed in such a way that their characteristics and standard.
performances during their intended use will not be

adversely affected during transport and storage taking
account of the instructions and information provided by
the manufacturer.
6. General Guidance notes 1 - 6 shall be observed
6 Any undesirable side-effect must constitute an Covered for hazardous outputs
acceptable risk when weighed against the inherent to MR equipment, see
performances intended.
a) for physiologic effects due to
electromagnetic field exposures:
201.12.4 Protection against
hazardous output
b) for acoustic noise:
201.9.6.2.1 Audible acoustic
energy
201.7.9.2.101 d) Exposure to
excessive acoustic noise
REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
II.
General Guidance notes 1 - 6 shall be observed
Chemical, physical and biological properties
7.1 The devices must be designed and manufactured in Covered for the certain particular
such a way as to guarantee the characteristics and device characteristics of MR
performances referred to in Section I (3) on the Equipment (see below)
‘General requirements’.
Particular attention must be paid to:
No. Essential Requirements Coverage of EN 60601-2-33
- the choice of materials used, particularly as No specific requirements in this
regards toxicity and, where appropriate, standard.
flammability,
- the compatibility between the materials used Not applicable for MR Equipment
and biological tissues, cells and body fluids, (per its intended use)
taking account of the intended purpose of the
device,
- where appropriate, the results of biophysical or Not applicable for MR Equipment
modeling research whose validity has been
demonstrated beforehand.
7.2 The devices must be designed, manufactured and No specific requirements in this
packed in such a way as to minimize the risk posed by standard.
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 the
exposure.
7.3 The devices must be designed and manufactured in No specific requirements in this
such a way that they can be used safely with the standard.
materials, substances and gases with which they enter
into contact during their normal use or during routine
procedures;
if the devices are intended to administer medicinal Not applicable for MR Equipment
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.
7.4 Where a device incorporates, as an integral part, a Not applicable for MR Equipment
substance which, if used separately, may be
considered to be a 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.
For the substances referred to in the first paragraph, Not applicable for MR Equipment
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.
No. Essential Requirements Coverage of EN 60601-2-33
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 ancillary substance
incorporated in a device, in particular related to its
manufacturing process, the notified body shall be
informed of the changes and shall consult the relevant
medicines competent authority (i.e. the one involved in
the initial consultation), in order to confirm that the
quality and safety of the ancillary substance are
maintained. The competent authority shall take into
account the data related to the usefulness of
incorporation of the substance into the device as
determined by the notified body, in order to ensure that
the changes have no negative impact on the
established benefit/risk profile of the addition of the
substance in the medical device.
When the relevant medicines competent authority (i.e.
the one involved in the initial consultation) has obtained
information on the ancillary substance, which could
have an impact on the established benefit/risk profile of
the addition of the substance in the medical device, it
shall provide the notified body with advice, whether this
information has an impact on the established
benefit/risk profile of the addition of the substance in
the medical device or not. The notified body shall take
the updated scientific opinion into account in
reconsidering its assessment of the conformity
assessment procedure.
7.5 The devices must be designed and manufactured in Covered with respect to accidental
such a way as to reduce to a minimum the risks posed Helium losses:
by substances leaking from the device.
201.7.9.3.101 (Technical
Description)
c) safety provisions in the event of
a quench, and
201.7.9.2.101 (Instructions for Use)
f) Liquid and gaseous cryogens
Special attention shall be given to substances which Not applicable for MR Equipment
are carcinogenic, mutagenic or toxic to reproduction, in
accordance with Annex I to Council Directive
67/548/EEC of 27 June 1967 on the approximation of
laws, regulations and administrative provisions relating
to the classification, packaging and labeling of
dangerous substances.
No. Essential Requirements Coverage of EN 60601-2-33
If parts of a device (or a device itself) intended to Not applicable for MR Equipment
administer and/or remove medicines, body liquids or
other substances to or from the body, or devices
intended for transport and storage of such body fluids
or substances, contain phthalates which are classified
as carcinogenic, mutagenic or toxic to reproduction, of
category 1 or 2, in accordance with Annex I to Directive
67/548/EEC, these devices must be labeled on the
device itself and/or on the packaging for each unit or,
where appropriate, on the sales packaging as a device
containing phthalates.
If the intended use of such devices includes treatment Not applicable for MR Equipment
of children or treatment of pregnant or nursing women,
the manufacturer must provide a specific justification for
the use of these substances with regard to compliance
with the essential requirements, in particular of this
paragraph, within the technical documentation and,
within the instructions for use, information on residual
risks for these patient groups and, if applicable, on
appropriate precautionary measures.
7.6 Devices must be designed and manufactured in such a No specific requirements in this
way as to reduce, as much as possible, risks posed by standard.
the unintentional ingress of substances into the device
taking into account the device and the nature of the
environment in which it is intended to be used.
8 Infection and microbial contamination General Guidance note 2 and 3
shall be observed
8.1 The devices and manufacturing processes must be No specific requirements in this
designed in such a way as to eliminate or reduce as far standard.
as possible the risk of infection to the patient, user and
third parties. The design must allow easy handling and,
where necessary, minimize contamination of the device
by the patient or vice versa during use.
8.2 Tissues of animal origin must originat
...