EN ISO 14708-5:2022

SLOVENSKI STANDARD
01-oktober-2022
Vsadki (implantati) za kirurgijo - Aktivni medicinski pripomočki za vsaditev - 5. del:
Naprave za podporo cirkulacije (ISO 14708-5:2020)
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support
devices (ISO 14708-5:2020)
Chirurgische Implantate - Aktive implantierbare medizinische Geräte - Teil 5: Besondere
Anforderungen an Kreislaufunterstützungssysteme (ISO 14708-5:2020)
Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 5: Appareils
annexes circulatoires (ISO 14708-5:2020)
Ta slovenski standard je istoveten z: EN ISO 14708-5:2022
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN ISO 14708-5

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2022
ICS 11.040.40
English version
Implants for surgery - Active implantable medical devices -
Part 5: Circulatory support devices (ISO 14708-5:2020)
Implants chirurgicaux - Dispositifs médicaux Chirurgische Implantate - Aktive implantierbare
implantables actifs - Partie 5: Dispositifs d'assistance medizinische Geräte - Teil 5: Besondere
circulatoire (ISO 14708-5:2020) Anforderungen an Kreislaufunterstützungssysteme
(ISO 14708-5:2020)
This European Standard was approved by CEN on 6 July 2022.

CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2022 CEN/CENELEC All rights of exploitation in any form and by any means
Ref. No. EN ISO 14708-5:2022 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3

European foreword
This document (EN ISO 14708-5:2022) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN-CENELEC/ JTC 16 “Active
Implantable Medical Devices” the secretariat of which is held by DKE.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2023, and conflicting national standards shall
be withdrawn at the latest by January 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN-CENELEC shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a Standardization Request given to CEN and CENELEC by the
European Commission and the European Free Trade Association.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14708-5:2020 has been approved by CEN-CENELEC as EN ISO 14708-5:2022 without
any modification.
INTERNATIONAL ISO
STANDARD 14708-5
Second edition
2020-05
Implants for surgery — Active
implantable medical devices —
Part 5:
Circulatory support devices
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 5: Dispositifs d'assistance circulatoire
Reference number
ISO 14708-5:2020(E)
©
ISO 2020
ISO 14708-5:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 14708-5:2020(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations . 5
5 General requirements for active implantable medical devices . 5
5.1 General requirements for non-implantable parts . 5
5.2 General requirements for software . 5
5.3 Usability of non-implantable parts . 5
5.4 Data security and protection from harm caused by unauthorized information tampering 6
5.5 General requirements for risk management . 6
5.6 Misconnection of parts of the active implantable medical device . 6
5.7 Wireless coexistence and wireless quality of service . 6
6 Requirements for particular active implantable medical devices . 6
6.1 Intended clinical use/indications . 6
6.2 System description . 6
6.2.1 General. 6
6.2.2 System configuration . 8
6.2.3 System performance and operating limits . 8
6.3 Design analysis . 8
6.3.1 General. 8
6.3.2 Human factors analysis . 8
6.4 Risk analysis . 9
6.5 Human factors .10
6.6 In vitro design evaluation and system performance testing .10
6.6.1 Objective . .10
6.6.2 System characterization .10
6.6.3 Subsystem component testing .13
6.7 Electromagnetic compatibility .17
6.8 Materials qualification .17
6.9 Biocompatibility .18
6.10 Dynamic haemolysis.18
6.11 Environmental testing .18
6.12 In vivo evaluation .18
6.12.1 Objective . .18
6.12.2 Definition of success or failure .19
6.12.3 Test articles . .19
6.12.4 Test system .19
6.12.5 Control .20
6.12.6 Test equipment .20
6.12.7 Preoperative animal care .20
6.12.8 Implant procedure.20
6.12.9 Special instructions for early termination .20
6.12.10 Postoperative care .21
6.12.11 Anticoagulation .21
6.12.12 Adverse events .21
6.12.13 System performance .21
6.12.14 Measurement of physiological parameters .21
6.12.15 Clinical pathology .21
6.12.16 Necropsy and device retrieval .21
6.12.17 Macroscopic examination .22
ISO 14708-5:2020(E)
6.12.18 Histological examination .22
6.12.19 Explanted device analysis .22
6.12.20 Data analysis .22
6.13 Reliability .22
6.14 Clinical evaluation .23
7 General arrangement of the packaging .23
8 General markings for active implantable medical devices .24
9 Markings on the sales packaging .24
10 Construction of the sales packaging .24
11 Markings on the sterile pack.24
12 Construction of the non-reusable pack .25
13 Markings on the active implantable medical device .25
14 Protection from unintentional biological effects being caused by the active
implantable medical device .25
15 Protection from harm to the patient or user caused by external physical features of
the active implantable medical device .26
16 Protection from harm to the patient caused by electricity .26
17 Protection from harm to the patient caused by heat .26
17.1 Protection from harm to the patient caused by heat .26
17.2 Active implantable medical device intended to supply heat .26
18 Protection from ionizing radiation released or emitted from the active implantable
medical device.26
19 Protection from unintended effects caused by the active implantable medical device .26
20 Protection of the active implantable medical device from damage caused by
external defibrillators .27
21 Protection of the active implantable medical device from changes caused by
electrical fields applied directly to the patient .27
22 Protection of the active implantable medical device from changes caused by
miscellaneous medical treatments .27
23 Protection of the active implantable medical device from mechanical forces .28
24 Protection of the active implantable medical device from damage caused by
electrostatic discharge .28
25 Protection of the active implantable medical device from damage caused by
atmospheric pressure changes .28
26 Protection of the active implantable medical device from damage caused by
temperature changes .28
27 Protection of the active implantable medical device from electromagnetic non-
ionizing radiation .29
27.1 General .29
27.2 Test conditions .29
27.2.1 Acceptance criteria .29
27.2.2 Test configuration and setup .29
27.2.3 Operating functions, modes, and settings .30
27.2.4 Patient physiological simulation .30
27.2.5 Immunity test levels.30
27.3 Risk management file and test report file documentation .30
27.4 Protection from static magnetic fields of flux density up to 50 mT .31
27.5 Protection from AC magnetic fields in the range of 1 kHz to 140 kHz .31
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ISO 14708-5:2020(E)
27.6 Protection from proximity fields due to RF wireless communications equipment .32
28 Accompanying documentation .32
Annex A (informative) Relationship between the fundamental principles in ISO/TR 14283
and the clauses of this document .36
Annex B (informative) Rationale .55
Annex C (informative) Pre-clinical in vitro/in silico evaluation .61
Annex D (informative) Active implantable medical device hazards, associated failure
modes, and evaluation methods.65
Bibliography .67
ISO 14708-5:2020(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.
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 (see 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 (see 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 6, Active implants.
This second edition cancels and replaces the first edition (ISO 14708-5:2010), which has been technically
revised. The main change compared to the previous edition is as follows:
— alignment to the revised ISO 14708-1:2014.
A list of all parts in the ISO 14708 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
vi © ISO 2020 – All rights reserved

ISO 14708-5:2020(E)
Introduction
This document specifies requirements for safety and performance of active implantable circulatory
support devices. It amends and supplements ISO 14708-1:2014, hereinafter referred to as ISO 14708-1.
The requirements of this document take priority over those of ISO 14708-1.
Heart failure is a major public health problem. It is estimated that worldwide more than 5 million
people die per year due to heart failure. In addition, it accounts for a large portion of health care
expenditure and rehospitalisation (see Reference [35]). Circulatory support devices are needed
for promoting myocardial recovery following acute heart failure as well as long-term support until
eventual transplantation or permanent therapy. Circulatory support devices may be fully implanted,
partially implanted, or delivered by percutaneous approach. The growth of heart failure is expected to
increase with the aging population (see Reference [30]).
The requirements of this document supplement or modify those of ISO 14708-1.
In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used
as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.
Information is also provided in Annex A that explains the relationship between ISO/TR 14283,
ISO 14708-1 and this document.
Notes on this document are provided in Annex B for information.
Annex C provides guidance on pre-clinical in vitro and in silico evaluation. Annex D provides information
device hazards, associated failure modes, and evaluation methods. All annexes are informative.
INTERNATIONAL STANDARD ISO 14708-5:2020(E)
Implants for surgery — Active implantable medical
devices —
Part 5:
Circulatory support devices
1 Scope
This document specifies requirements for safety and performance of active implantable circulatory
support devices, including 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.
The tests that are specified in this document are type tests and are to be carried out on a sample of a
device to assess device behavioural responses and are not intended to be used for the routine testing of
manufactured products.
Included in the scope of this document are:
— ventricular assist devices (VAD), left or right heart support;
— total artificial hearts (TAH);
— biventricular assist devices (biVAD);
— percutaneous assist devices;
— paediatric assist devices.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General
requirements for safety, marking and for information to be provided by the manufacturer
ISO 14971:2019, Medical devices — Application of risk management to medical devices
IEC 60068-1:2013, Environmental testing — Part 1: General and guidance
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
ISO 14708-5:2020(E)
IEC 60068-2-64:2008, Environmental testing — Part 2-64: Tests — Test Fh: vibration, broadband random
and guidance
IEC 60601-1:2018, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance – Collateral standard: Usability
IEC 60601-1-10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety and
essential performance — Collateral standard: Requirements for the development of physiologic closed-loop
controllers
IEC 60601-1-11:2015, 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
IEC 62304:2006, Medical device software — Software life cycle processes
IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
accessory device
separate part of a circulatory support system that is not essential to the primary function of the
circulatory support system
Note 1 to entry: Examples are programming units, monitoring units and alternative power source (3.18) units.
3.2
artificial valve
prosthetic valve
component of the circulatory support system that directs the unidirectional flow of the blood into and
out of the pump
3.3
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 (3.31) replacement
3.4
biVAD
biventricular assist device
configuration in which two VADs are used to support both ventricles respectively
3.5
cavitation
sudden formation and collapse of low-pressure bubbles in the blood by means of mechanical forces
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ISO 14708-5:2020(E)
3.6
circulatory support device
electromechanical device that is used to partially or completely replace the left and/or right ventricular
function of a failing heart
3.7
conduit
component of the circulatory support system that connects the pump to the patient’s circulation
3.8
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
3.9
diastolic pressure
arithmetic average of minimum pressures in a pulsatile pressure waveform over a sufficient number of
cycles to filter out cyclic variation
3.10
display
component of the circulatory support system that allows data pertaining to the operation of the system
to be observed
3.11
driveline
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.
3.12
durability
ability of an item to perform a required function under given conditions of use and maintenance, until a
limiting state is reached
Note 1 to entry: 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.
3.13
DUT
device under test
3.14
ejection/fill
E/F
ratio between the ejection time period and the filling time period of the blood pump cycle
Note 1 to entry: E/F is identical to S/D (systolic/diastolic) when related to the natural heart.
3.15
failure
termination of the ability of an item to perform a required function
Note 1 to entry: After failure, the item has a fault (3.16).
Note 2 to entry: “Failure” is an event, as distinguished from “fault”, which is a state.
Note 3 to entry: This concept as defined does not apply to items consisting of software only.
ISO 14708-5:2020(E)
3.16
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 1 to entry: A fault is often the result of a failure (3.15) of the item itself but might exist without prior failure.
3.17
labelling
marking
any written, printed, electronic information, 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
3.18
power source
source of energy (battery, mains)
3.19
pulsatile flow
characteristic of the output of a pump where the flow is time dependent
3.20
pulse pressure
difference between the systolic and diastolic pressure (3.9) readings
Note 1 to entry: It represents the force that the heart generates each time it contracts.
3.21
pump output
performance measure for a circulatory support system indicating the volume of blood pumped into the
host circulatory system per minute
Note 1 to entry: The pump output is expressed in litres per minute or its equivalent in other units.
3.22
volume displacement
pump displacement
pump that imparts its pumping action by changing the volume of the pumping chamber
EXAMPLE By displacement of a diaphragm or pusher plate.
3.23
reliability
probability that an item can perform a required function under given conditions for a given time
interval (t1, t2) for a specified confidence level
Note 1 to entry: 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 to entry: The term “reliability” is also used to denote the reliability performance quantified by this
[11]
probability .
3.24
rotary pump
pump that imparts its pumping action directly on the blood by a rotating mechanism
3.25
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
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ISO 14708-5:2020(E)
3.26
safety
freedom from unacceptable risk
Note 1 to entry: See ISO/IEC Guide 51.
3.27
sales packaging
packaging that protects and identifies the device during storage and handling by the purchaser
Note 1 to entry: The sales packaging should be enclosed in further packaging, for example a “shipping package”,
for delivery.
3.28
service life
period after implantation when the circulatory support system remains within stated specifications
and characteristics
Note 1 to entry: The service life of the components of the system can vary (implanted components might have
longer lifetimes versus the peripheral components which are replaceable).
3.29
stroke volume
amount of blood pumped by the ventricle of the heart in one contraction
3.30
transcutaneous energy transmission system
TETS
system used to send electrical energy wirelessly into a device implanted inside the body
3.31
total artificial heart
TAH
circulatory support system that replaces the pumping function of a patient’s native heart
3.32
ventricular assist device
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 abbreviations
The text in ISO 14708-1:2014, Clause 4 applies.
5 General requirements for active implantable medical devices
5.1 General requirements for non-implantable parts
The text in ISO 14708-1:2014, 5.1 applies.
5.2 General requirements for software
The text in ISO 14708-1:2014, 5.2 applies.
5.3 Usability of non-implantable parts
The text in ISO 14708-1:2014, 5.3 applies.
ISO 14708-5:2020(E)
5.4 Data security and protection from harm caused by unauthorized information
tampering
The text in ISO 14708-1:2014, 5.4 applies.
5.5 General requirements for risk management
The text in ISO 14708-1:2014, 5.5 applies.
5.6 Misconnection of parts of the active implantable medical device
The text in ISO 14708-1:2014, 5.6 applies.
5.7 Wireless coexistence and wireless quality of service
When communication with any part of an active implantable medical device is provided through
wireless communication channels, the manufacturer shall evaluate wireless coexistence and wireless
quality of service through the risk management process and apply the appropriate risk control
measures to protect the patient from harm (see 27.6).
Testing of wireless communication channels, for EMC, is performed in accordance with
IEC 60601-1-2:2014.
Compliance is checked by the inspection of the risk management file.
6 Requirements for particular active implantable medical devices
6.1 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), where it may be used safely (e.g. hospital,
home, ground and/or air transport vehicles), and the intended duration of use. 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.
Compliance is checked by the inspection of the manufacturer’s documentation.
6.2 System description
6.2.1 General
A comprehensive description of the system shall be documented, including discussions on the principles
of operation, rationale for key design choices, system configurations, system components, and system
performance and operating limits.
Compliance is checked by the inspection of the manufacturer’s documentation.
The rationale for key design choices, for example:
— approaches taken to minimize blood component damage;
— methods for thermal management;
— choice of drive mechanisms;
— power management scheme;
— choice of connectors to prevent misuse;
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ISO 14708-5:2020(E)
— reliability considerations;
— adequacy of anatomic fit;
— electromagnetic compatibility (EMC)/ interference;
— driveline damage resistance;
— exposure to environmental conditions;
— human factors.
Design specifications for the complete system include the full range of system operating limits for each
parameter, for example:
— beat rates;
— E/F ratio;
— rotation speeds;
— power consumption;
— flow rate as a function of pressure head (with varying pump rotational speed or beat rate).
Required system components, for example:
— hydrodynamic bearings;
— magnetic bearings.
System operational modes, for example:
— manual;
— automatic.
System component configurations, for example:
— hospital;
— home;
— power sources;
— optional display;
— optional subsystems;
— optional console.
Alarm thresholds, and all associated tolerances on each of these parameters.
Principle(s) of operation, for example:
— blood pumping mechanism;
— connections to the cardiovascular system;
— power system;
— control mechanisms.
ISO 14708-5:2020(E)
6.2.2 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.
Compliance is checked by the inspection of the manufacturer’s documentation.
6.2.3 System performance and operating limits
The entire performance range of the system shall be give
...