prEN ISO 11608-4

SLOVENSKI STANDARD
01-maj-2016
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 4. del:
Peresa za injiciranje z elektronskimi elementi (ISO/DIS 11608-4:2016)
Needle-based injection systems for medical use - Requirements and test methods - Part
4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 4: Kanülenbasierte Injektionssysteme, die elektronische Bauteile
enthalten (ISO/DIS 11608-4:2016)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 4: Systèmes d'injection à aiguille électroniques (ISO/DIS 11608-4:2016)
Ta slovenski standard je istoveten z: prEN ISO 11608-4
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 11608-4
ISO/TC 84 Secretariat: DS
Voting begins on: Voting terminates on:
2016-02-11 2016-05-10
Needle-based injection systems for medical use -
Requirements and test methods —
Part 4:
Needle-based injection systems containing electronics
Systèmes d’injection à aiguille pour usage médical — Exigences et méthodes d’essai —
Partie 4: Systèmes d’injection à aiguille électroniques
ICS: 11.040.25
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11608-4:2015(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2015

ISO/DIS 11608-4:2015(E)
ISO/DIS 11608-4:2016
Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviated terms . 24
5 General requirements . 24
6 General requirements for testing . 24
7 Classification of ENIS . 25
8 Identification, marking and documentation . 25
9 Protection against electrical hazards . 34
10 Protection against mechanical hazards . 80
11 Protection against unwanted and excessive radiation hazards . 80
12 Protections against excessive temperatures and other hazards . 81
13 Accuracy of controls and instruments and protection against hazardous outputs . 82
14 Hazardous situations and fault conditions . 83
15 Programmable medical electrical systems . 87
16 Construction of ME equipment . 87
17 ME systems . 91
18 Requirements for Electromagnetic Compatibility (EMC) . 92
19 Test report . 94
© ISO 2015, Published in Switzerland
Annex A (informative) Rationale for statistical sampling . 95
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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copyright@iso.org
www.iso.org
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ISO/DIS 11608-4:2016
Contents
Foreword . 4
Introduction. 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Symbols and abbreviated terms . 24
5 General requirements . 24
6 General requirements for testing . 24
7 Classification of ENIS . 25
8 Identification, marking and documentation . 25
9 Protection against electrical hazards . 34
10 Protection against mechanical hazards . 80
11 Protection against unwanted and excessive radiation hazards . 80
12 Protections against excessive temperatures and other hazards . 81
13 Accuracy of controls and instruments and protection against hazardous outputs . 82
14 Hazardous situations and fault conditions . 83
15 Programmable medical electrical systems . 87
16 Construction of ME equipment . 87
17 ME systems . 91
18 Requirements for Electromagnetic Compatibility (EMC) . 92
19 Test report . 94
Annex A (informative) Rationale for statistical sampling . 95

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ISO/DIS 11608-4:2016
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 84 Devices for administration of medicinal
products and intravascular catheters.
ISO 11608 consists of the following parts, under the general title Needle-based injection systems for
medical use — Requirements and test methods:
 Part 1: Needle-based injection systems
 Part 2: Needles
 Part 3: Finished containers
 Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
 Part 5: Automated functions
 Part 6: On-body delivery system
 Part 7: Requirements for accessibility for persons with visual impairment

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ISO/DIS 11608-4:2016
Introduction
This part of ISO 11608 covers Needle-based injection systems containing electronics (with or without
software). These injectors are primarily intended to administer medicinal products to humans. This
part of ISO 11608 provides performance requirements regarding essential aspects of the design so that
variations of such injectors are not unnecessarily restricted.
For historical reasons (ISO 11608-1 was published before ISO 11608-4), the first edition of this part of
ISO 11608 was limited to pen-injectors with electromechanical drive systems. Pen-injectors only
equipped with electronics were covered in ISO 11608-1. Given the set of additional tests that need to be
performed regarding needle-based injection systems containing electronics (ENIS) regardless of what
the electronics are used for, it was decided to have all types of electronics covered by this standard.
Materials to be used for construction are not specified, as their selection will depend on the design, the
intended use and the process of manufacture used by individual manufacturers.
There are other international and national standards and guidance publications and, in some countries,
national regulations that are applicable to medical devices and pharmaceuticals. This part of the
standard serves as a stand-alone document for ENIS that specifies relevant aspects of the IEC 60601
series for this particular device type. This standard does not specify particular test methods, conditions,
or acceptance criteria for NIS; other parts of ISO 11608 specify these requirements. Rather, this
standard serves as a guideline for those developing ENIS. If a clause from IEC 60601-1 is not listed, it
can be considered not applicable to the device under consideration.
Their requirements might supersede or complement this part of ISO 11608. Developers and
manufacturers of ENISs are encouraged to investigate and determine whether there are any other
requirements relevant to the safety or marketability of their products.
Manufacturers are expected to follow a risk-based approach during the design, development and
manufacture of the product. Given the specific medicinal product and intended use, this might result in
product-specific requirements and test methods that differ from what is outlined in this part of ISO
11608.
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ISO/DIS 11608-4:2016
Needle-based injection systems for medical use — Requirements
and test methods — Part 4: Needle-based injection systems
containing electronics
1 Scope
This part of ISO 11608 specifies reference requirements and test methods for needle-based injection
systems (NIS) containing electronics (with or without software) intended to be used with needles and
with replaceable or non-replaceable containers. The electronic needle based injection system (ENIS)
can be single use, reusable, and/or rechargeable. It is intended to deliver medication to an end-user by
self-administration or with assistance.
This part of ISO 11608 is not applicable for devices that are capable of delivering drug while connected
to an external power supply.
This part of ISO 11608 is not applicable for ancillary electrical equipment such as chargers for the
device.
This part of ISO 11608 is not applicable for needle-free injectors (as covered in ISO 21649).
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.
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
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
3 Terms and definitions
3.1
access cover
part of an enclosure or guard providing the possibility of access to electrical equipment parts for the
purpose of adjustment, inspection, replacement or repair
3.2
accessible part
part of electrical equipment other than an applied part that can be touched by means of the standard
test finger
NOTE to entry: See also 5.9.2.1.
3.3
accessory
additional part for use with equipment in order to:
– achieve the intended use,
– adapt it to some special use,
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ISO/DIS 11608-4:2016
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
[IEC 60788:2004, rm-83-06 modified]
3.4
accompanying document
document accompanying ME equipment, an ME system, equipment or an accessory and containing
information for the responsible organization or operator, particularly regarding basic safety and
essential performance
3.5
air clearance
shortest path in air between two conductive parts
NOTE to entry: Adapted from IEC 60664-1:2007, definition 3.2.
3.6
appliance coupler
means enabling the connection of a flexible cord to electrical equipment without the use of a tool,
consisting of two parts: a mains connector and an appliance inlet
NOTE to entry: See Figure 1.
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ISO/DIS 11608-4:2016
Key
1 appliance coupler 6 mains connector
2 applicance inlet 7 mains plug
3 detachable power supply cord
4 ME equipment
5 fixed mains socket-outlet/multiple socket-outlet (MSO)

Figure 1 — Detachable mains connection
3.7
appliance inlet
part of an appliance coupler either integrated in or fixed to electrical equipment
NOTE to entry: See Figure 1 and Figure 2.
3.8
applied part
part of ME equipment that in normal use necessarily comes into physical contact with the patient for
ME equipment or an ME system to perform its function
NOTE 1 to entry: See Figure 3, Figure 4 and Figure A.1 to Figure A.7 (inclusive).
NOTE 2 to entry: See also 4.6 regarding the treatment of parts that do not fall within the definition of applied
parts but need to be treated as applied parts as a result of applying the risk management process.
NOTE 3 to entry: See also 3.78 for the definition of the associated term patient connection.
3.9
basic insulation
insulation providing basic protection against electric shock
NOTE to entry: Basic insulation provides one means of protection.
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Key
1 appliance inlet (see also Figure 1) 10 mains connector
2 patient connection 11 mains plug
3 conduit 12 mains terminal device
4 detachable power supply cord 13 power supply cord
5 enclosure 14 protective earth conductor
6 fixed wiring 15 protective earth terminal
7 functional earth conductor 16 mains plug
8 signal input/output part 17 potential equalization conductor
9 mains conductor connector 18 terminal for the connection of a potential
equalization conductor
Figure 2 — Example of the defined terminals and conductors

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ISO/DIS 11608-4:2016
Key
1 mains plug with protective earth contact 8 secondary circuit
2 detachable power supply cord 9 mains part
3 appliance coupler 10 applied part
4 protective earth contact and pin 11 motor
5 functional earth terminal 12 protectively earthed screen
6 basic insulation 13 supplementary insulation
7 enclosure 14 shaft that is an accessible part

Figure 3 — Example of a Class I ME equipment

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ISO/DIS 11608-4:2016
Key
1 mains plug 6 functional earth terminal
2 power supply cord 7 mains part
3 basic insulation 8 applied part
4 supplementary insulation 9 reinforced insulation
5 enclosure 10 motor
Figure 4 — Example of a metal-enclosed Class II ME equipment
3.10
basic safety
freedom from unacceptable risk directly caused by physical hazards when ME equipment is used under
normal condition and single fault condition
3.11
class I
term referring to electrical equipment in which protection against electric shock does not rely on basic
insulation only, but which includes an additional safety precaution in that means are provided for
accessible parts of metal or internal parts of metal to be protectively earthed
NOTE to entry: See Figure 3.
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ISO/DIS 11608-4:2016
3.12
class II
term referring to electrical equipment in which protection against electric shock does not rely on basic
insulation only, but in which additional safety precautions such as double insulation or reinforced
insulation are provided, there being no provision for protective earthing or reliance upon installation
conditions
NOTE 1 to entry: See Figure 4.
NOTE 2 to entry: Class II equipment can be provided with a functional earth terminal or a functional earth
conductor. See also 8.6.8 and 8.6.9.
3.13
clearly legible
capable of being read by a person with normal vision
NOTE to entry: See the test in 7.1.2.
3.14
continuous operation
operation in normal use for an unlimited period of time without the specified limits of temperature
being exceeded
3.15
creepage distance
shortest distance along the surface of the insulating material between two conductive parts
3.16
defibrillation-proof applied part
applied part that is protected against the effects of a discharge of a cardiac defibrillator to the patient
3.17
detachable power supply cord
flexible cord intended to be connected to electrical equipment by means of a suitable appliance coupler
for mains supply purposes
NOTE to entry: See Figure 1, Figure 2 and Figure 3.
3.18
direct cardiac application
use of applied part that can come in direct contact with the patient’s heart
3.19
double insulation
insulation comprising both basic insulation and supplementary insulation
NOTE to entry: Double insulation provides two means of protection.
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3.20
duty cycle
maximum activation (on) time followed by minimum deactivation (off) time necessary for the safe
operation of the ME equipment
3.21
earth leakage current
current flowing from the mains part through or across the insulation into the protective earth
conductor or a functional earthed connection according to 8.6.9
3.22
enclosure
exterior surface of electrical equipment or parts thereof
NOTE to entry: For the purpose of testing to this standard, metal foil, with specified dimensions, applied in
contact with parts of the exterior surface made of material with low conductivity or made of insulating material is
considered a part of the enclosure (see Figure 2, Figure 3 and Figure 4).
3.23
ENIS
[Electronic Needle-based Injection System]
injection system containing electronics intended for parenteral administration by injection of medicinal
products using a needle and a multi-dose or single-dose container
3.24
essential performance
performance necessary to achieve freedom from unacceptable performance of a clinical function, other
than that related to basic safety, where loss or degradation beyond the limits specified by the
manufacturer results in an unacceptable risk
NOTE to entry: Essential performance is most easily understood by considering whether its absence or
degradation would result in an unacceptable risk.
3.25
expected service life
maximum period of useful life as defined by the time period specified by the manufacturer during
which the me equipment or me system is expected to remain safe for use (i.e. maintain basic safety and
essential performance)
NOTE to entry: Maintenance can be necessary during the expected service life.
3.26
f-type isolated (floating) applied part (herein f-type applied part)
applied part in which the patient connections are isolated from other parts of the ME equipment to such
a degree that no current higher than the allowable patient leakage current flows if an unintended
voltage originating from an external source is connected to the patient, and thereby applied between
the patient connection and earth
NOTE to entry: F-type applied parts are either type bf applied parts or type cf applied parts.
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ISO/DIS 11608-4:2016
3.27
functional earth terminal
terminal, directly connected to a circuit or to a screening part, that is intended to be earthed for
functional purposes
NOTE to entry: See Figure 2, Figure 3 and Figure 4.
3.28
guard
part of equipment specifically used to provide protection by means of a physical barrier
NOTE to entry: Depending on its construction, a guard can be called a casing, cover, screen, door, enclosing
guard, etc. A guard can act:
– alone; it is then only effective when it is in place;
– in conjunction with an interlocking device with or without guard locking; in this case, protection is ensured
whatever the position of the guard.
3.29
hazard
potential source of harm
[ISO 14971:2007, definition 2.3]
3.30
hazardous situation
circumstance in which people, property, or the environment are exposed to one or more hazard(s)
[ISO 14971:2007, definition 2.4]
3.31
insulation co-ordination
mutual correlation of insulation characteristics of electrical equipment taking into account the expected
micro-environment and other influencing stresses
NOTE to entry: This includes insulation types, creepage distances, air clearances, distance through insulation,
coatings, encapsulation, environmental aspects, etc.
3.32
intended use
intended purpose
use for which a product, process or service is intended according to the specifications, instructions and
information provided by the manufacturer
[ISO 14971:2007, definition 2.5]
NOTE to entry: Intended use should not be confused with normal use. While both include the concept of use
as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not
only the medical purpose, but maintenance, transport, etc. as well.
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ISO/DIS 11608-4:2016
3.33
internal electrical power source
electrical power source for operating equipment that is a part of the equipment and which produces
electrical current from some other form of energy
EXAMPLE: Chemical, mechanical, solar, or nuclear
NOTE to entry: An internal electrical power source can be inside the principal part of equipment, attached to
the outside, or contained in a separate enclosure.
3.34
internally powered
term referring to electrical equipment that is able to operate from an internal electrical power source
3.35
leakage current
current that is not functional
NOTE to entry: The following leakage currents are defined: earth leakage current, touch current and patient
leakage current
3.36
mains connector
part of an appliance coupler integral with or intended to be attached to a flexible cord that is intended
to be connected to the supply mains
NOTE to entry: A mains connector is intended to be inserted into the appliance inlet of electrical equipment
(see Figure 1 and Figure 2).
3.37
mains part
electrical circuit part of electrical equipment forming a circuit that is intended to be connected to the
supply mains
NOTE 1 to entry: The mains part includes all conductive parts that are not separated from the supply mains by
at least one means of protection.
NOTE 2 to entry: For the purpose of this definition, the protective earth conductor is not regarded as a part of
the mains part (see Figure 2 and Figure 3).
3.38
mains plug
part, integral with or intended to be attached to a power supply cord of electrical equipment, to be
inserted into a mains socket-outlet
NOTE 1 to entry: See Figure 1.
NOTE 2 to entry: See also IEC 60083 and IEC 60309-1 [8].
3.39
mains terminal device
terminal device by which the electrical connection to the supply mains is made
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ISO/DIS 11608-4:2016
NOTE to entry: See Figure 2.
3.40
mains transient voltage
highest peak voltage expected at the power input to the electrical equipment, arising from external
transients on the supply mains
3.41
mains voltage
voltage of a supply mains between two line conductors of a polyphase system or voltage between the
line conductor and the neutral conductor of a single-phase system
3.42
maximum mains voltage
voltage used for test purposes related to the voltage of the supply mains and connected to certain
ME equipment parts
NOTE to entry: The value for maximum mains voltage is determined according to 8.5.3.
3.43
means of operator protection
[moop]
means of protection for reducing the risk due to electric shock to persons other than the patient
3.44
means of patient protection
[mop]
means of protection for reducing the risk due to electric shock to the patient
3.45
means of protection
[mop]
means for reducing the risk due to electric shock in accordance with the requirements of this standard
NOTE to entry: Means of protection include insulation, air clearances, creepage distances, impedances, and
protective earth connections.
3.46
mechanical hazard
hazard connected with or produced by physical force
3.47
network/data coupling
any means to transmit or receive information to or from other equipment in accordance with the
manufacturer’s specifications
EXAMPLE: Nominal mains voltage or nominal diameter of a screw.
3.48
normal condition
condition in which all means provided for protection against hazards are intact
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3.49
normal use
operation, including routine inspection and adjustments by any operator, and stand-by, according to the
instructions for use
NOTE to entry: Normal use should not be confused with intended use. While both include the concept of use
as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not
only the medical purpose, but maintenance, transport, etc. as well.
3.50
objective evidence
information which can be proven true, based on facts obtained through observation, measure data
supporting the existence or verity of something
NOTE to entry: Objective evidence can be obtained through observation, measurement, testing or other means.
[ISO 14971: 2007, definition 2.10]
3.51
operator
person handling equipment
NOTE to entry: See also 3.101.
3.52
over-current release
protective device that causes a circuit to open, with or without time-delay, when the current in the
device exceeds a predetermined value
3.53
oxygen rich environment
environment in which the concentration of oxygen is:
a) greater than 25 % for ambient pressures up to 110 kPa; or
b) the partial pressure of oxygen is greater than 27,5 kPa at ambient pressures exceeding 110 kPa
3.54
patient
living being (person or animal) undergoing a medical, surgical or dental procedure
NOTE to entry: A patient can be an operator.
3.55
patient auxiliary current
current flowing in the patient in normal use between any patient connection and all other patient
connections and not intended to produce a physiological effect
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ISO/DIS 11608-4:2016
3.56
patient connection
individual point on the applied part through which current can flow between the patient and the
ME equipment in normal condition or single fault condition
3.57
patient environment
any volume in which intentional or unintentional contact can occur between a patient and parts of the
ME equipment or ME system or between a patient and other persons touching parts of the ME Equipment
or ME system
3.58
patient leakage current
current:
– flowing from the patient connections via the patient to earth; or
– originating from the unintended appearance of a voltage from an external source on the patient and
flowing from the patient via the patient connections of an f-type applied part to earth

3.59
peak working voltage
highest peak or d.c. value of a working voltage, including repetitive peak impulses generated in the
electrical equipment, but not including external transients
[IEC 60950-1: 2005, definition 1.2.9.8, modified]
3.60
permanently installed
term meaning electrically connected to the supply mains by means of a permanent connection that can
only be detached by the use of a tool
3.61
potential equalization conductor
conductor other than a protective earth conductor or a neutral conductor, providing a direct connection
between electrical equipment and the potential equalization busbar of the electrical installation
NOTE to entry: See Figure 2.
3.62
power supply cord
flexible cord, fixed to or assembled with electrical equipment for connection to supply mains
NOTE to entry: See Figure 1 to Figure 4 (inclusive).
3.63
protective earth conductor
conductor to be connected between the protective earth terminal and an external protective earthing
system
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ISO/DIS 11608-4:2016
NOTE to entry: See Figure 2.
3.64
protective earth connection
connection to the protective earth terminal provided for protective purposes and complying with the
requirements of this standard
3.65
protective earth terminal
terminal connected to conductive parts of class I equipment for safety purposes. This terminal is
intended to be connected to an external protective earthing system by a protective earth conductor
NOTE to entry: See Figure 2.
3.66
protectively earthed
connected to the protective earth terminal for protective purposes by means complying with the
requirements of this standard
3.67
reinforced insulation
single insulation system that provides two means of protection
3.68
responsible organization
entity accountable for the use and maintenance of an ME equipment or an ME system
NOTE 1 to entry: The accountable entity can be, for example, a hospital, an individual clinician or a layperson. In
home use applications, the patient, operator and responsible organization can be one and the same person.
NOTE 2 to entry: Education and training is included in “use.”
3.69
risk
combination of the probability of occurrence of harm and the severity of that harm
[ISO 14971: 2007, definition 2.16]
3.70
risk control
process in which decisions are made and measures implemented by which risks are reduced to, or
maintained within, specified levels
[ISO 14971: 2007, definition 2.19]
3.71
risk management
systematic application of management policies, procedures and practices to the tasks of analyzing,
evaluating and controlling risk
[ISO 14971: 2007, definition 2.22]
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ISO/DIS 11608-4:2016
NOTE to entry: For the purposes of this standard, risk management does not include planning for or monitoring
of production and post-production information; whereas this is required for compliance with ISO 14971 (see
4.2.2).
3.72
risk management file
set of records and other documents that are produced by risk management
[ISO 14971: 2007, definition 2.23]
NOTE to entry: All safety related information including manufacturer's calculations, test results, etc. is
considered to be part of the risk management file. See also 4.2.
3.73
safe working load
maximum external mechanical load (mass) on equipment or an equipment part that is permitted in
normal use
3.74
secondary circuit
circuit which is separated from the mains part by at least one means of protection and derives its power
from a transformer, converter or equivalent isolation device, or from an internal electrical power
source
NOTE to entry: See also 8.9.1.12.
3.75
service personnel
individuals or entity accountable to the responsible organization that install, assemble, maintain or
repair me equipment, ME systems or equipment
3.76
signal input/output part
[sip/sop]
part of ME equipment, not being an applied part, intended to deliver or receive signals to or from other
electrical equipment, for example, for display, recording or data processing
NOTE to entry: See Figure 2.
3.77
single fault condition
condition of ME equipment in which a single means for reducing a risk is defective or a single abnormal
condition is present
NOTE to entry: See 4.7 and 13.2.
3.78
single fault safe
characteristic of me equipment or its parts whereby it remains free of unacceptable risk during its
expected service life under single fault conditions
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NOTE to entry: See 4.7.
3.79
stationary
term referring to equipment that, once installed and placed into service, is not intended to be moved
from one place to another
3.80
supplementary insulation
independent insulation applied in addition to basic insulation in order to provide protection against
electric shock in the event of a failure of basic insulation
NOTE to entry: Supplementary insulation provides one means of protection.
3.81
supply mains
source of electrical energy not forming part of ME equipment or ME system
NOTE to entry: This also includes battery systems and converter systems in ambulances and the like.
3.82
terminal device
part of electrical equipment by which electrical connection is made
NOTE to entry: A terminal device can contain several individual contacts.
3.83
thermal cut-out
device that, during an abnormal condition, limits the temperature of electrical equipment or of part of it,
by automatically opening the circuit or by reducing the current, and that is so constructed that its
setting cannot be altered except by qualified service personnel
3.84
thermal stability
condition under which the temperature of an object does not increase by more than 2 C over a period
of 1 h
3.85
tool
extra-corporeal object that can be used to secure or release fasteners or to make adjustments
NOTE to entry: Coins and keys are considered tools within the context of this standard.
3.86
touch current
leakage current flowing from the enclosure or from parts thereof, excluding patient connections,
accessible to any operator or patient in normal use, through an external path other than the protective
earth conductor, to earth or to another part of the enclosure
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ISO/DIS 11608-4:2016
NOTE to entry: The meaning of this term is the same as that of “enclosure leakage current” in the first and
second editions of this standard. The term has been changed to align with IEC 60950-1 and to reflect the fact that
the measurement now applies also to parts that are normally protectively earthed.
3.87
type b applied part
applied part complying with the specified requirements of this standard to provide protection against
electric shock, particularly regarding allowable patient leakage current and patient auxiliary current
NOTE 1 to entry: A type b applied part is marked with symbol IEC 60417-5840 (2002-10) (see Table D.1,
symbol 19) or, when applicable, with symbol IEC 60417-5841 (2002-10) (see Table D.1, symbol 25). See also 3.20.
NOTE 2 to entry: Type b applied parts are not suitable for direct cardiac application.
NOTE 3 to entry: See also 4.6 regarding the treatment of parts that do not fall within the definition of applied
parts but need to be considered as applied parts as a result of applying the risk management process.
3.88
type bf applied part
F-type applied part complying with the specified requirements of this standard to provide a higher
degree of protection against electric shock than that provided by type b applied parts
NOTE 1 to entry: A type bf applied part is marked with symbol IEC 60417-5333 (2002-10) (see Table D.1,
symbol 20) or, when applicable, with symbol 60417-5334 (2002-10) (see Table D.1, symbol 26). See also 3.20.
NOTE 2 to entry: Type bf applied parts are not suitable for direct cardiac application.
NOTE 3 to entry: See also 4.6 regarding the treatment of parts that do not fall within the definition of applied
parts but need to be considered as applied parts as a result of applying the risk management process.
3.89
type cf applied part
f-type applied part complying with the specified requirements of this standard to provide a higher
degree of protection against electric shock than that provided by type bf applied parts
NOTE 1 to entry: A type cf applied part is marked with symbol IEC 60417-5335 (2002-10) (see Table D.1,
symbol 21) or, when applicable, with symbol 60417-5336 (2002-10) (see Table D.1, symbol 27). See also 3.20.
NOTE 2 to entry: See also 4.6 regarding the treatment of parts that do not fall within the definition of applied
parts but need to be considered as applied parts as a result of applying the risk management process.
NOTE 3 to entry: See the rationale for the definition of direct cardiac application (3.22) concerning the applied
parts that need to be type cf applied parts.
3.90
type test
test on a representative sample of the equipment with the objective of determining if the equipment, as
designed and manufactured, can meet the requirements of this standard
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ISO/DIS 11608-4:2016
3.91
usability
characteristic of the operator interface that establishes effectiveness, efficiency, ease of operator
learning and operator satisfaction
[IEC 62366:2007, definition 3.17, modified]
3.92
usability engineering
application of knowledge about human behaviour, abilities, limitations, and other characteristics to the
design of tools, devices, systems, tasks, jobs, and environments to achieve adequate usability
[IEC 62366:2007, definition 3.18]
3.93
verification
confirmation, through the provision of objective evidence that specified requirements have been
fulfille
...