ISO 14708-5:2010
(Main)Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
ISO 14708-5:2010 specifies requirements for safety and performance of active implantable circulatory support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps. ISO 14708-5:2010 specifies type tests, animal studies and clinical evaluation requirements.
Implants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 5: Appareils annexes circulatoires
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 14708-5
First edition
2010-02-01
Implants for surgery — Active
implantable medical devices —
Part 5:
Circulatory support devices
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 5: Appareils annexes circulatoires
Reference number
ISO 14708-5:2010(E)
©
ISO 2010
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ISO 14708-5:2010(E)
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ii © ISO 2010 – All rights reserved
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ISO 14708-5:2010(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Symbols and abbreviated terms .6
5 General requirements for non-implantable parts.6
6 Requirements for particular active implantable medical devices .6
7 General arrangement of the packaging.19
8 General markings for active implantable medical devices .19
9 Markings on the sales packaging .19
10 Construction of the sales packaging .20
11 Markings on the sterile pack .20
12 Construction of the non-reusable pack .20
13 Markings on the active implantable medical device.21
14 Protection from unintentional biological effects caused by the active implantable medical
device.21
15 Protection from harm to the patient or user caused by external physical features of the
active implantable medical device.21
16 Protection from harm to the patient caused by electricity.21
17 Protection from harm to the patient caused by heat .21
18 Protection from ionizing radiation released or emitted from the active implantable
medical device .21
19 Protection from unintended effects caused by the device .21
20 Protection of the device from damage caused by external defibrillators .23
21 Protection of the device from changes caused by high-power electrical fields applied
directly to the patient .23
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments.23
23 Protection of the active implantable medical device from mechanical forces .23
24 Protection of the active implantable medical device from damage caused by electrostatic
discharge.23
25 Protection of the active implantable medical device from damage caused by atmospheric
pressure changes.23
26 Protection of the active implantable medical device from damage caused by temperature
changes .23
27 Protection of the active implantable medical device from electromagnetic non-ionizing
radiation.23
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ISO 14708-5:2010(E)
28 Accompanying documentation .23
Annex AA (informative) Relationship between the fundamental principles in ISO/TR 14283 and the
clauses of this part of ISO 14708 .26
Annex BB (informative) Relationship between the clauses of this part of ISO 14708 and the
fundamental principles listed in Annex AA .35
Annex CC (informative) Rationale .37
Annex DD (informative) In vitro test .42
Bibliography .46
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ISO 14708-5:2010(E)
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 14708-5 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants.
ISO 14708 consists of the following parts, under the general title Implants for surgery — Active implantable
medical devices:
⎯ Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
⎯ Part 2: Cardiac pacemakers
⎯ Part 3: Implantable neurostimulators
⎯ Part 4: Implantable infusion pumps
⎯ Part 5: Circulatory support devices
⎯ Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia
(including implantable defibrillators)
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ISO 14708-5:2010(E)
Introduction
This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory
support devices. It is not intended to be used for extracorporeal perfusion devices, cardiomyoplasty, heart
restraint devices, and counter-pulsation devices such as extra- or intra-aortic balloon pumps. It amends and
supplements ISO 14708-1:2000, hereinafter referred to as ISO 14708-1. The requirements of this part of
ISO 14708 take priority over those of ISO 14708-1.
Heart failure (HF) is a major public health problem. It is estimated that worldwide more than 5 million people
die per year due to heart failure. The number of newly diagnosed cases is more than 550 000 per year in the
[13]
USA alone (AHA ). In 2001, nearly 53 000 patients in the United States died of HF as a primary cause.
Further, heart failure is implicated as a contributing factor in more than 250 000 deaths each year in the USA
[29]
alone (Yusuf ). Particularly at a higher risk for heart failure are the elderly (> 60 years), who account for
[18]
70 % of heart failure patients (Haldeman et al ), and for whom congestive heart failure is the leading cause
of hospitalization. From 1990 to 1999, the annual number of hospitalizations has increased from
approximately 810 000 to over 1 million for HF as a primary diagnosis and from 2,4 million to 3,6 million for HF
[30]
as a primary or secondary diagnosis (Koelling TM et al, ). The economic costs are enormous. It has been
estimated that in 2005, the total direct and indirect cost of HF in the United States is equal to $27,9 billion
[13]
(AHA ). Worldwide, it is estimated that over $900 billion per year is spent and almost one third of patients
are younger than 60. Heart transplantation in recent years has become an effective treatment for end-stage
heart failure. Unfortunately the number of donor hearts is limited to just about 3 000 worldwide, available only
to a small fraction of patients who need heart transplants. Future drug discoveries and/or biological therapies
such as cell regeneration and gene therapy hold promise for the future in the treatment of chronic heart failure.
However, as of today, mechanical circulatory devices remain the only alternative to heart transplantation and
will continue to be a viable treatment for end-stage heart failure for the foreseeable future.
Within this part of ISO 14708, the following terms are used to amend and supplement ISO 14708-1:
“Replacement”: the clause of ISO 14708-1 is replaced completely by the text of this particular part of
ISO 14708.
“Addition”: the text of this particular part is additional to the requirements of ISO 14708-1.
“Amendment”: the clause of ISO 14708-1 is amended as indicated by the text of this particular part of
ISO 14708.
“Not used”: the clause of ISO 14708-1 is not applied in this particular part of ISO 14708.
Subclauses, figures, or tables that are additional to those of ISO 14708-1 are numbered starting from 101;
additional annexes are lettered AA, BB, etc.
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INTERNATIONAL STANDARD ISO 14708-5:2010(E)
Implants for surgery — Active implantable medical devices —
Part 5:
Circulatory support devices
1 Scope
This part of ISO 14708 specifies requirements for safety and performance of active implantable circulatory
support devices. It is not applicable to extracorporeal perfusion devices, cardiomyoplasty, heart restraint
devices and counter-pulsation devices, such as extra- or intra-aortic balloon pumps.
This part of ISO 14708 specifies type tests, animal studies and clinical evaluation requirements.
NOTE The device that is commonly referred to as an active implantable medical device can in fact be a single
device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these
parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-
implantable parts and accessories if they could affect the safety or performance of the implantable device.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 5198, Centrifugal, mixed flow and axial pumps — Code for hydraulic performance tests — Precision
grade
ISO 5840, Cardiovascular implants — Cardiac valve prostheses
ISO 7198, Cardiovascular implants —Tubular vascular prostheses
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
1)
ISO 14155 , Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14708-1, Implants for surgery — Active implantable medical devices — Part 1: General requirements for
safety, marking and for information to be provided by the manufacturer
ISO 14971, Medical devices — Application of risk management to medical devices
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-1, Medical electrical equipment — Part 1-1: General requirements for safety — Collateral
standard: Safety requirements for medical electrical systems
1) To be published. (Revision of ISO 14155-1 and ISO 14155-2)
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ISO 14708-5:2010(E)
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-8, 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 62304, Medical device software — Software life cycle processes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14708-1 and ISO 14971 and the
following apply.
3.101
accessory device
separate part of a circulatory support system that is not essential to the primary function of the circulatory
support system
NOTE Examples are programming units, monitoring units and alternative power supply units.
3.102
artificial valve
prosthetic valve
component of the circulatory support system that directs the unidirectional flow of the blood into and out of the
pump
3.103
atrial cuff
connector between the right or left atrial ring after resection of the natural ventricle and the inlet of the right or
left blood pump in total artificial heart replacement
3.104
cavitation
sudden formation and collapse of low pressure bubbles in the blood by means of mechanical forces
3.105
clinical study
evaluation of a device in humans
3.106
conduit
component of the circulatory support system that connects the pump to the patient’s circulation
3.107
controller
component of the circulatory support system that contains the logic, circuitry and/or software to control the
driving mechanism that enables the system to perform its primary function
3.108
diastolic pressure
arithmetic average of diastolic blood pressure (when the left ventricle is not contracting), over a sufficient
number of cycles to filter out cyclic variation, of the minimum aortic pressures in a pulsatile pressure waveform
3.109
dp/dt
time derivative of pressure giving the rate of change of pressure with respect to time
NOTE dp/dt is expressed in millimetres of mercury per second, mmHg/s (kiloPascal per second [kPa/s] in SI units).
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ISO 14708-5:2010(E)
3.110
dQ/dt
time derivative of flow giving the rate of change of flow with respect to time
NOTE dQ/dt is expressed in units of litres per minute per second.
3.111
drive line
tube and/or cable that connects a driver or energy source to the pump
EXAMPLE The tube that connects a pneumatic console to a pneumatically driven pump.
3.112
durability
ability of an item to perform a required function under given conditions of use and maintenance, until a limiting
state is reached
NOTE A limiting state of an item should be characterized by the end of the useful life, unsuitability for any economic
or technological reasons, or other relevant factors.
3.113
ejection/fill
E/F
ratio between the ejection time period and the filling time period of the blood pump cycle
NOTE E/F is identical to S/D (systolic/diastolic) when related to the natural heart.
3.114
extracorporeal component
component or subsystem of the circulatory support system that is kept external to the patient (outside of the
body)
3.115
failure
termination of the ability of an item to perform a required function
NOTE 1 After failure, the item has a fault.
NOTE 2 “Failure” is an event, as distinguished from “fault”, which is a state.
NOTE 3 This concept as defined does not apply to items consisting of software only.
3.116
fault
state of an item characterized by inability to perform a required function, excluding the inability during
preventive maintenance or other planned actions, or due to lack of external resources
NOTE A fault is often the result of a failure of the item itself, but might exist without prior failure.
3.117
fully implantable
implanted circulatory support system with no skin penetrations (i.e. percutaneous lead)
3.118
hazard analysis
identification of hazards and their initiating causes
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ISO 14708-5:2010(E)
3.119
labelling
marking
any written, printed, or graphical matter affixed to a medical device or any of its containers or wrappers, or
accompanying the medical device related to identification, technical description and use, but excluding
shipping documents
3.120
monitor
component of the circulatory support system that allows data pertaining to the operation of the system to be
displayed
3.121
peak flow
maximum flow rate during ejection of blood from a pump into the host circulatory system
3.122
peak pressure
maximum pressure generated by the circulatory support system
3.123
percutaneous lead
lead (electrical or otherwise) that crosses the patient's skin to connect implantable parts of a circulatory
support system to extracorporeal parts of the system
3.124
power supply
source of energy
3.125
pulsatile flow
characteristic of the output of a pump where the flow is time-dependent (flow varies with time during one beat)
3.126
pump fill
filling phase of a volume displacement pump
NOTE Diastole is used to describe only the filling phase of the host’s native ventricle(s).
3.127
pump output
performance measure for a circulatory support system indicating the volume of blood pumped into the host
circulatory system per minute
NOTE The pump output is expressed in litres per minute or its equivalent in other units.
3.128
pump/pulse rate
performance measure for a circulatory support system indicating the number of complete pump cycles per
minute
NOTE The pump rate is expressed in beats per minute.
3.129
pump stroke volume
performance measure for a circulatory support system indicating the volume pumped into the host circulatory
system per beat by a pump with pulsatile flow
NOTE The pump stroke volume is expressed in millilitres.
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ISO 14708-5:2010(E)
3.130
pump volume
volumetric capacity of the pump
3.131
pump displacement
volume displacement
pump that imparts its pumping action by changing the volume of the pumping chamber
EXAMPLE By displacement of a diaphragm or pusher plate.
3.132
reliability
probability that an item can perform a required function under given conditions for a given time interval (t1, t2)
NOTE 1 It is generally assumed that the item is in a state to perform this required function at the beginning of the time
interval.
NOTE 2 The term “reliability” is also used to denote the reliability performance quantified by this probability [see 191-
02-06 of IEC 60050-191 definition of reliability (performance)].
3.133
remote access device
component of the circulatory support system that allows modification and/or monitoring of the controller and
the operation of the system
3.134
rotary pump
pump that imparts its pumping action directly on the blood by a rotating mechanism
3.135
safe and effective
reasonable assurance that a device will not induce harm to the recipient and that it will provide clinical benefit
for the recipient for its conditions of use
3.136
safety
freedom from unacceptable risk
[ISO/IEC Guide 51:1999, definition 3.1]
3.137
safety hazard
potentially detrimental effect on the patient, other persons, animals, or the surroundings, arising directly from
the circulatory support system
3.138
sales packaging
packaging that protects and identifies the device during storage and handling by the purchaser
NOTE The sales packaging should be enclosed in further packaging, for example a “shipping package”, for delivery.
3.139
stroke volume
amount of blood pumped by the ventricle of the heart in one contraction
3.140
systolic pressure
arithmetic average, over a sufficient number of cycles to filter out cyclic variation, of the peak aortic pressures
in a pulsatile pressure waveform
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ISO 14708-5:2010(E)
3.141
transcutaneous energy transmission system
TETS
system used to send electrical energy wirelessly into a device implanted inside the body
3.142
total artificial heart
TAH
circulatory support system that replaces the pumping function of a patient’s native heart
3.143
ventricular assist system
ventricular assist device
VAS/VAD
circulatory support system that augments the function of either one or both ventricles of the patient's native
heart by capturing blood from the atrium(a) or ventricle(s) and providing work to pump blood into the
pulmonary and/or systemic circulation
4 Symbols and abbreviated terms
This clause of ISO 14708-1 applies.
5 General requirements for non-implantable parts
This clause of ISO 14708-1 applies.
6 Requirements for particular active implantable medical devices
Addition
6.101 Intended clinical use/indications
The intended use and indications for the device system shall be described. The intended use describes what
the device system does (e.g. provides circulatory support) and where it may be used safely (e.g. hospital,
home, ground and/or air transport vehicles). The indications are the disease(s) or condition(s) the device will
diagnose, treat, prevent, cure, or mitigate and a description of the target population for which the device is
intended without causing unreasonable risk of illness or injury associated with use of the device.
6.102 System description
6.102.1 General
A comprehensive description of the system should be documented, including discussions on the principle(s) of
operation, design consideration(s), system configuration(s), system component(s), and system performance
and operating limits.
Design specifications for the complete system include the full range of system operating limits for each
parameter (e.g. beat rates, E/F ratio, rotation speeds, power), system operational modes (e.g. manual,
automatic), system component configurations (e.g. hospital, home, power sources, optional display, optional
subsystems, optional console), alarm thresholds, and all associated tolerances on each of these parameters.
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ISO 14708-5:2010(E)
6.102.2 Principle of operation
A discussion of the operating principle of the system should include the blood pumping mechanism,
connections to the cardiovascular system, power system, and control mechanisms.
6.102.3 Design consideration
The rationale for key design choices should be given. This should include, but is not limited to, approaches
taken to minimize blood component damage, methods for thermal management, choice of drive mechanisms,
a power management scheme, reliability considerations, adequacy of anatomic fit, and patient interaction.
6.102.4 System configuration
A detailed physical description of the system shall be given including implantation sites of various implantable
components, external wearable units, and external consoles. Size, shape, weight, and volume of the
components should be given, as well as the different configurations of system components that can be used
to provide support.
6.102.5 System performance and operating limits
The entire performance range of the system shall be given, even if some operation conditions are not
expected to be used clinically or might cause the system to malfunction.
6.103 Design analysis
A comprehensive analysis should be performed for the integrated system, the various component
configurations, as well as for each system component for all safety and effectiveness issues, including human
factors. The in vitro, in vivo, and clinical testing performed to address each issue should be identified.
6.104 Risk analysis
Risk analysis, part of the risk management process, should be performed on the system. The risk analysis
should include a top-down analysis (such as a hazard analysis or fault tree analysis, FTA), a bottom up
analysis (such as failure mode, effects, and criticality analysis, FMECA), as well as an analysis for potential
use or user error (human factors analysis). The risk analysis should utilize a method to classify the severity of
failure modes, the probability of occurrence, the risk priority number, and the detection method. The analysis
should include discussion of methods used to mitigate the criticality of the failure modes (see 19.2).
NOTE For further information on risk analysis, see ISO 14971.
6.105 Human factors
Human factors evaluation should consist of both integrated system testing and subsystem testing. The user
interface, both hardware and software, should be designed to be understandable and compatible with the
intended users' anticipated capabilities (e.g. physical, mental, or sensory) to reduce the likelihood of error
and/or confusion. Further, appropriate alarms and warnings are necessary and shall be designed to warn
users of system or subsystem failures. Guidance for human factors can be found in IEC 62366.
6.106 In vitro design evaluation and system performance testing
6.106.1 Objective
In vitro testing shall include design characterization of the integrated system and its individual system
subcomponents against all of its system design specifications. Test set-ups should be reasonably
representative of the intended patient population in which pressures, compliances and flow should be at
appropriate values. A description of the in vitro testing systems, including all pressures, compliances, and the
location of all measurement equipment, as well as the rationale for the test set-up, shall be provided.
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ISO 14708-5:2010(E)
In both a volume displacement pump and a rotary pump VAD system, this testing i
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