IEC 60601-1-12:2014

IEC 60601-1-12
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour les appareils électromédicaux
et les systèmes électromédicaux destinés à être utilisés dans l'environnement
des services médicaux d'urgence

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IEC 60601-1-12
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –

Part 1-12: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems intended for use in the emergency medical services

environment
Appareils électromédicaux –
Partie 1-12: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences pour les appareils électromédicaux

et les systèmes électromédicaux destinés à être utilisés dans l'environnement

des services médicaux d'urgence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040 ISBN 978-2-8322-1654-5

– 2 – IEC 60601-1-12:2014 © IEC 2014
CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope, object and related standards . 8
1.1 * Scope . 8
1.2 * Object . 8
1.3 Related standards . 9
1.3.1 IEC 60601-1 . 9
1.3.2 Particular standards . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General requirements . 11
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS . 11
4.2 * Environmental conditions for ME EQUIPMENT . 11
4.2.1 * Environmental conditions of transport and storage between uses . 12
4.2.2 * Environmental operating conditions . 13
5 * Classification of ME EQUIPMENT and ME SYSTEMS . 15
6 ME EQUIPMENT identification, marking and documents . 16
6.1 * Additional requirements for legibility of markings . 16
6.2 * Additional requirements for marking of IP classification . 16
6.3 * Instructions for use . 16
6.3.1 Additional general requirements . 16
6.3.2 * Additional requirements for an electrical power source . 17
6.3.3 Additional requirements for ME EQUIPMENT start-up PROCEDURE . 17
6.3.4 * Additional requirements for operating instructions . 18
6.3.5 Additional requirements for ME EQUIPMENT messages . 18
6.4 Technical description – FIXED or PERMANENTLY INSTALLED CLASS I
ME EQUIPMENT . 18
7 * Protection against electrical HAZARDS from ME EQUIPMENT . 18
8 Protection against excessive temperatures and other HAZARDS . 19
8.1 Additional requirements for ingress of water or particulate matter into
ME EQUIPMENT and ME SYSTEMS . 19
8.1.1 * Ingress of water or particulate matter into ME EQUIPMENT . 19
8.1.2 * Ingress of water or particulate matter into ME SYSTEMS . 19
8.2 Additional requirements for interruption of the power supply to ME EQUIPMENT
and ME SYSTEM . 19
8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for
ME EQUIPMENT . 20
9 * Accuracy of controls and instruments and protection against hazardous outputs . 21
10 Construction of ME EQUIPMENT . 21
10.1 * Additional requirements for mechanical strength of ME EQUIPMENT intended
for the EMS ENVIRONMENT . 21
10.1.1 General requirements for mechanical strength . 21
10.1.2 * Requirements for mechanical strength for FIXED or PERMANENTLY
INSTALLED ME EQUIPMENT intended for use in a road ambulance . 22
10.1.3 * Requirements for mechanical strength for TRANSPORTABLE
ME EQUIPMENT . 23

10.1.4 * Requirements for mechanical strength for ME EQUIPMENT intended for
airborne use . 24
10.2 Requirements for mounting of ME EQUIPMENT . 25
11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS . 25
Annex A (informative) General guidance and rationale . 26
A.1 General guidance . 26
A.2 Rationale for particular clauses and subclauses . 28
Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 42
B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 42
B.2 ACCOMPANYING DOCUMENTS, instructions for use . 42
B.3 ACCOMPANYING DOCUMENTS, technical description . 43
Annex C (informative) Symbols on marking . 44
Bibliography . 46
Index of defined terms used in this collateral standard . 48

Figure A.1 – Saturation water vapour pressure as function of temperature . 31

Table 1 – Mechanical strength test applicability . 22
Table A.1 – Saturation water vapour pressure as function of temperature . 32
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 42
Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use . 42
Table B.3 – ACCOMPANYING DOCUMENTS, technical description . 43
Table C.1 – General symbols . 44

– 4 – IEC 60601-1-12:2014 © IEC 2014
INTERNATIONAL ELECTROTECHNICAL COMMISSION
_______________
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-12: General requirements for basic
safety and essential performance –
Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use
in the emergency medical services environment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
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5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
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services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-1-12 has been prepared by a joint working group of
IEC subcommittee 62A: Common aspects of electrical equipment used in medical practice, of
IEC technical committee 62: Electrical equipment in medical practice, and ISO subcommittee
SC3: Lung ventilators and related devices, of ISO technical committee 121: Anaesthetic and
respiratory equipment.
This first edition constitutes a collateral standard to IEC 60601-1 (third edition): Medical
electrical equipment – Part 1: General requirements for basic safety and essential
performance hereafter referred to as the general standard.

The text of this collateral standard is based on the following documents:
FDIS Report on voting
62A/932/FDIS 62A/938/RVD
Full information on the voting for the approval of this collateral standard can be found in the
report on voting indicated in the above table. In ISO, this International Standard has been
approved by 18 P-members out of 19 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In the 60601 series of publications, collateral standards specify general requirements for
safety applicable to:
– a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or
– a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fully addressed in the
general standard (e.g. ALARM SYSTEMS).
In this collateral standard, the following print types are used:
– requirements and definitions: roman type.
– test specifications: 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 DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the 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 7.3.1 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 collateral 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 H 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.
Clauses, subclauses and definitions for which a rationale is provided in informative Annex A
are marked with an asterisk (*).
A list of all parts of the IEC 60601 series, published under the general title: Medical electrical
equipment, can be found on the IEC website.

– 6 – IEC 60601-1-12:2014 © IEC 2014
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations may need a transitional period following publication of a new, amended or
revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip
themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this
publication be adopted for implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
re print this document using a
understanding of its contents. Users should therefo
colour printer.
INTRODUCTION
Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
SYSTEMS for monitoring, treatment or diagnosis of PATIENTS in the EMERGENCY MEDICAL
SERVICES ENVIRONMENT (see 3.1). The safety of MEDICAL ELECTRICAL EQUIPMENT in this
uncontrolled, rough environment is a cause for concern.
This collateral standard was developed with contributions from clinicians, engineers and
regulators. The terminology, requirements, general recommendations and guidance of this
collateral standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for the
development of particular standards.

– 8 – IEC 60601-1-12:2014 © IEC 2014
MEDICAL ELECTRICAL EQUIPMENT –

Part 1-12: General requirements for basic
safety and essential performance –
Collateral Standard: Requirements for medical electrical
equipment and medical electrical systems intended for use
in the emergency medical services environment

1 Scope, object and related standards
1.1 * Scope
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, which are intended, as indicated in the instructions for use by
MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES
their
ENVIRONMENT), as defined in 3.1.
NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use.
The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the
MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT.
The EMS ENVIRONMENT includes
– responding to and providing life support at the scene of an emergency to a PATIENT
reported as experiencing injury or illness in a pre-hospital setting, and transporting the
PATIENT, while continuing such life support care, to an appropriate professional healthcare
facility for further care.
– providing monitoring, treatment or diagnosis during transport between professional
healthcare facilities.
This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely
for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in
professional healthcare facilities covered by IEC 60601-1 without the additions of
IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely
intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple
use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within
the scope of this standard.
EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare
facility environment.
NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical
sources and outdoor environmental conditions.
1.2 * Object
The object of this collateral standard is to provide general requirements for ME EQUIPMENT and
ME SYSTEMS carried to the scene of an emergency and used there, as well as in transport, in
situations where the ambient conditions differ from indoor conditions.
The object of this collateral standard is to specify general requirements that are in addition to
those of the general standard and to serve as the basis for particular standards.

1.3 Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT and ME SYSTEMS, this collateral standard complements IEC 60601-1,
hereafter referred to as the general standard.
When referring to IEC 60601-1 or to this collateral standard, either individually or in
combination, the following conventions are used:
– "the general standard" designates IEC 60601-1 alone;
– "this collateral standard" designates IEC 60601-1-12 alone;
– "this standard" designates the combination of the general standard and this collateral
standard.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirement in
this collateral standard.
2 Normative references
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 1 The way in which these referenced documents are cited in normative requirements determines the extent
(in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography on page 46.
IEC 60068-2-27:2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance:
Shock
IEC 60068-2-31:2008, Environmental testing – Part 2-31: Tests – Test Ec: Rough handling
shocks, primarily for equipment-type specimens
IEC 60068-2-64:2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration,
broadband random and guidance
IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)
IEC 60529:1989/AMD1:1999
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
______________
There exists a consolidated edition 2.1(2001) including IEC 60529:1989 and its Amendment 1:1999.
There exists a consolidated edition 3.1(2012) including IEC 60601-1:2005 and its Amendment 1:2012.

– 10 – IEC 60601-1-12:2014 © IEC 2014
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-8:2006, Medical electrical equipment – 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 60601-1-8:2006/AMD1:2012
IEC 60601-1-11:— , Medical electrical equipment – Part 1-11: General requirements for basic
safety and essential performance – Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment
CISPR 11:2009, Industrial, scientific and medical equipment – Radio-frequency disturbance
characteristics – Limits and methods of measurement
ISO 7000:2014, Graphical symbols for use on equipment – Registered symbols
ISO 7010:2011, Graphical symbols – Safety colours and safety signs – Registered safety
signs
Amendment 1:2012
Amendment 2:2012
Amendment 3:2012
Amendment 4:2013
Amendment 5:2014
ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
EUROCAE ED-14G, Environmental conditions and test procedures for airborne equipment
RTCA DO-160G, Environmental Conditions and Test Procedures for Airborne Equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005 and
IEC 60601-1:2005/AMD1:2012, IEC 60601-1-6:2006 and IEC 60601-1-6:2006/AMD1:2013,
IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:— and the
following definitions apply.
NOTE 1 Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. values of an
alternating, direct or composite voltage or current unless stated otherwise.
NOTE 2 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. This
standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in
the context of an ME SYSTEM.
NOTE 3 An index of defined terms used in this collateral standard is found beginning on page 48.
______________
There exists a consolidated edition 2.1(2012) including IEC 60601-1-8:2006 and Amendment 1:2012.
Second edition, to be published.
5 EUROCAE (European Organization for Civil Aviation Electronics), 102 rue Etienne Dolet, 92240 Malakoff,
France.
6 RTCA (Radio Technical Commission for Aeronautics), 1150 18th St, NW., Suite 910, Washington, DC 20036,
USA.
3.1
* EMS ENVIRONMENT
EMERGENCY MEDICAL SERVICES ENVIRONMENT
actual conditions and settings, in which OPERATORS interact with the ME EQUIPMENT or
ME SYSTEM, in and around the scene of an emergency outside of a professional healthcare
facility where a PATIENT can be given medical care, basic or advanced life support as well as
during professional transport to a professional healthcare facility or between professional
healthcare facilities
EXAMPLE 1 Responding to and providing life support at the scene of an emergency to a PATIENT reported as
experiencing injury or illness in a pre-hospital setting, and transporting the PATIENT, while continuing such life
support care, to an appropriate professional healthcare facility for further care.
EXAMPLE 2 Providing monitoring, treatment or diagnosis during transport between professional healthcare
facilities.
Note 1 to entry: For the purposes of this standard, use of equipment intended for the EMS ENVIRONMENT and
temporarily used in the HOME HEALTHCARE ENVIRONMENT by emergency medical personnel is considered use in the
EMS ENVIRONMENT.
Note 2 to entry: For the purposes of this standard, the OPERATORS of equipment intended for the
EMS ENVIRONMENT are presumed to be professional medical personnel or personnel with relevant specialized
training.
Note 3 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical
centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms and
multiple treatment facilities.
Note 4 to entry: Emergency medical services are known by various names in different countries and regions.
Note 5 to entry: For the purposes of this standard, transport includes road, rotary and fixed-wing ambulances.
4 General requirements
4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
For ME EQUIPMENT or ME SYSTEMS intended for the EMS ENVIRONMENT, the characteristics of the
SUPPLY MAINS specified in 4.10.2 of the general standard apply, with the following additions.
SUPPLY MAINS in the EMS ENVIRONMENT shall be assumed to have the following characteristics
of no voltage in excess of 110 % or lower than 85 % of the NOMINAL voltage between any of
the conductors of the system or between any of these conductors and earth.
The RATED range of NOMINAL voltage of the ME EQUIPMENT in the EMS ENVIRONMENT shall
include at least 12,4 V to 15,1 V for operation from 12 V d.c. SUPPLY MAINS and at least 24,8 V
to 30,3 V for operation from 24 V d.c. SUPPLY MAINS.
ME EQUIPMENT and ME SYSTEMS in the EMS ENVIRONMENT shall maintain BASIC SAFETY and
ESSENTIAL PERFORMANCE during and following a 30 s dip to 10 V from a 12 V d.c. SUPPLY MAINS
and during and following a 30 s dip to 20 V for operation from a 24 V d.c. SUPPLY MAINS.
For ME EQUIPMENT or ME SYSTEMS intended to be powered from an aircraft, the SUPPLY MAINS
shall comply with Section 16 of either EUROCAE ED-14G or RTCA DO-160G.
4.2 * Environmental conditions for ME EQUIPMENT
NOTE In IEC 60601-1:2005, the MANUFACTURER specifies the permissible environmental conditions of use,
including conditions for transport and storage in the technical description (see 7.9.3.1, second dash). These
conditions are referenced in requirements for testing throughout the general standard, (e.g. 5.3 and 11.1.1).

– 12 – IEC 60601-1-12:2014 © IEC 2014
4.2.1 * Environmental conditions of transport and storage between uses
The instructions for use shall indicate the permissible environmental conditions of transport
and storage of ME EQUIPMENT after the ME EQUIPMENT has been removed from its protective
packaging and subsequently between uses.
Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with this
standard and shall remain operational in NORMAL USE within its specification after transport or
storage in the following environmental range:
– - 40 °C to + 5 °C without relative humidity control;
– + 5 °C to + 35 °C at a relative humidity up to 90 %, non-condensing;
– > 35 °C to 70 °C at a water vapour pressure up to 50 hPa;
after having been removed from its protective packaging and subsequently between uses.
NOTE 1 This represents class 7K4, as described in IEC TR 60721-4-7:2001 [6] .
If the instructions for use state a more restricted range of environmental transport and storage
conditions between uses, these environmental conditions shall be:
– justified in the RISK MANAGEMENT FILE;
– marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the
more restricted range need only be disclosed in the instructions for use; and
– marked on the carrying case, if the instructions for use indicate that the ME EQUIPMENT is
intended to be transported or stored in a carrying case between uses.
Symbols 5.3.5 (ISO 7000-0534), 5.3.6 (ISO 7000-0533) or 5.3.7 (ISO 7000-0632) of
ISO 15223-1:2012 may be used to mark the temperature range (see Table C.1, symbols 2, 3
and 4). Symbol 5.3.8 (ISO 7000-2620) of ISO 15223-1:2012 may be used to mark the
humidity range (see Table C.1, symbol 5) and symbol 5.3.9 (ISO 7000-2621) of
ISO 15223-1:2012 may be used to mark the atmospheric pressure range (see Table C.1,
symbol 6). Where ME EQUIPMENT has different markings for conditions of transport and storage
between uses, continuous operating conditions (see 4.2.2.1) and transient operating
conditions (see 4.2.2.2), those markings shall be accompanied by supplementary marking
(e.g. appropriate wording) except where the respective applicability would be obvious (e.g.
limits for transport and storage between uses on the carrying case and limits for operation on
the ME EQUIPMENT itself).
Compliance is checked by the following test and, when a more restricted range is stated in the
instructions for use, inspection of the RISK MANAGEMENT FILE.
a) Prepare the ME EQUIPMENT for transport or storage according to instructions for use.
EXAMPLES Removal of batteries, emptying fluid reservoirs
b) Expose the ME EQUIPMENT at its lowest specified environmental transport and storage
conditions (temperature °C) for:
−4
− at least 16 h; or
− ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
c) Then expose the ME EQUIPMENT to 34 °C ± 4 °C and 93 % ± 3 % relative humidity until the
test chamber reaches equilibrium. The transition from low to high conditions should be
made slowly enough to provide a non-condensing environment. Hold for at least 2 h.
______________
Numbers in square brackets refer to the Bibliography.

d) Then expose the ME EQUIPMENT at its highest specified environmental transport and
storage conditions, but not requiring a water vapour partial pressure greater than 50 hPa,
+4
(temperature °C) for:
− at least 16 h; or
− ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
NOTE 2 The intent of specifying a minimum duration of the exposure to both the low and high temperature
conditions is to ensure that the entire ME EQUIPMENT reaches the stated conditions.
e) At the end of this conditioning period, allow the ME EQUIPMENT to return and stabilize at the
operating conditions of NORMAL USE.
f) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
and ESSENTIAL PERFORMANCE.
4.2.2 * Environmental operating conditions
4.2.2.1 Continuous operating conditions
The instructions for use shall indicate the permissible continuous environmental operating
conditions of the ME EQUIPMENT.
Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with its
specifications and all the requirements of this standard when operated in NORMAL USE under
the following environmental operating conditions:
– a temperature range of 0 °C to + 40 °C;
– a relative humidity range of 15 % to 90 %, non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa; and
– an atmospheric pressure range of 620 hPa to 1 060 hPa.
NOTE 1 This represents class 7K1 as described in IEC TR 60721-4-7:2001 [6].
If the instructions for use state a more restricted range of continuous environmental operating
conditions, these conditions shall be:
– justified in the RISK MANAGEMENT FILE;
– marked on the ME EQUIPMENT, unless such marking is not practicable, in which case the
more restricted range need only be disclosed in the instructions for use; and
– marked on the carrying case if the instructions for use indicate the ME EQUIPMENT is
intended to be operated in a carrying case.
Symbols 5.3.5 (ISO 7000-0534), 5.3.6 (ISO 7000-0533) or 5.3.7 (ISO 7000-0632) of
ISO 15223-1:2012 may be used to mark the temperature range (see Table C.1, symbols 2, 3
and 4). Symbol 5.3.8 (ISO 7000-2620) of ISO 15223-1:2012 may be used to mark the
humidity range (see Table C.1, symbol 5) and symbol 5.3.9 (ISO 7000-2621) of
ISO 15223-1:2012 may be used to mark the atmospheric pressure range (see Table C.1,
symbol 6). Where ME EQUIPMENT has different markings for continuous operating conditions
and transient operating conditions (4.2.2.2), those markings shall be accompanied by
supplementary marking (e.g. appropriate wording).
The ME EQUIPMENT shall comply with its specifications and all the requirements of this
standard when operated in NORMAL USE under the specified environmental operating
conditions. If readings or performance vary, a table of correcting values shall be disclosed in
the instructions for use. This correction table shall indicate the extent of the variation between
the actual values and the values indicated or set.
Compliance is checked by the following test and, when a more restricted range is stated in the
instructions for use, inspection of the RISK MANAGEMENT FILE:

– 14 – IEC 60601-1-12:2014 © IEC 2014
a) Set up the ME EQUIPMENT for operation according to its INTENDED USE.
b) Expose the ME EQUIPMENT to 20 °C ± 4 °C:
− for at least 6 h, or
− ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
c) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
ESSENTIAL PERFORMANCE.
and
d) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
ESSENTIAL PERFORMANCE while at the lowest specified atmospheric pressure.
and
e) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
and ESSENTIAL PERFORMANCE while at the highest specified atmospheric pressure.
NOTE 2 For ME EQUIPMENT that is pressure-sensitive (e.g. utilizes or measures gas or pressures or uses
membrane switches) evaluation of BASIC SAFETY and ESSENTIAL PERFORMANCE while the pressure changes in
either direction can be needed.
f) Relieve the pressure in the pressure chamber.
g) Cool the ME EQUIPMENT to its lowest specified continuous environmental operating
conditions (temperature °C and relative humidity less than or equal to 15 %).
−4
h) Hold the ME EQUIPMENT at its lowest specified continuous environmental operating
conditions:
− for at least 6 h, or
− ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
i) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
and ESSENTIAL PERFORMANCE.
j) Warm the ME EQUIPMENT to its highest specified continuous environmental operating
conditions, but not requiring a water vapour partial pressure greater than 50 hPa,
+4
(temperature °C).
k) Hold the ME EQUIPMENT at the conditions of j):
− for at least 6 h, or
− ensure that the ME EQUIPMENT reaches THERMAL STABILITY for at least 2 h.
l) Evaluate the ME EQUIPMENT to its specifications and ensure that it provides BASIC SAFETY
and ESSENTIAL PERFORMANCE.
4.2.2.2 * Transient operating conditions
The instructions for use shall indicate the permissible transient environmental operating
conditions of EMS ENVIRONMENT ME EQUIPMENT.
Unless otherwise indicated in the instructions for use, the ME EQUIPMENT shall comply with its
specifications and all the requirements of this standard when operated in NORMAL USE for a
period not less than 20 min under the following environmental operating conditions:
– a temperature range of - 20 °C to + 50 °C;
– a relative humidity range of 15 % to 90 %, non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa.
If the instructions f
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