ISO 14708-1:2014

DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION

Implants for surgery — Active implantable medical devices —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2013

ISO/DIS 14708-1
©  ISO 2013
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/DIS 14708-1
ISO/TC 150/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2013-04-22 2013-07-22
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION

Implants for surgery — Active implantable medical devicesr —
Part 1:
General requirements for safety, marking and for information to
be provided by the manufacturer
Implants chirurgicaux — Dispositifs médicaux implantables actifs —
Partie 1: Exigences générales pour la sécurité, le marquage et pour les informations à fournir par le fabricant
[Revision of first edition (ISO 14708-1:2000)]
ICS 11.040.40
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, 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 NATIONAL REGULATIONS.
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.
©  International Organization for Standardization, 2013

ISO/DIS 147-8-1
©  ISO 2013
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2013 – All rights reserved

ISO/DIS 14708-1
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Symbols and abbreviations (optional) . 7
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES . 7
6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES . 9
7 General arrangement of the packaging . 9
8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES . 10
9 MARKINGS on the SALES PACKAGING . 10
10 Construction of the SALES PACKAGING . 12
11 Markings on the STERILE PACK . 12
12 Construction of the NON-REUSABLE PACK . 13
13 Markings on the ACTIVE IMPLANTABLE MEDICAL DEVICE . 14
14 Protection from unintentional biological effects being caused by the ACTIVE IMPLANTABLE
MEDICAL DEVICE . 15
15 Protection from HARM to the patient or user caused by external physical features of the
ACTIVE IMPLANTABLE MEDICAL DEVICE . 17
16 Protection from HARM to the patient caused by electricity . 17
17 Protection from HARM to the patient caused by heat . 18
18 Protection from ionizing radiation released or emitted from the ACTIVE IMPLANTABLE
MEDICAL DEVICE . 18
19 Protection from unintended effects caused by the ACTIVE IMPLANTABLE MEDICAL DEVICE . 19
20 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by external
defibrillators . 20
21 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by electrical
fields applied directly to the patient . 23
22 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from changes caused by
miscellaneous medical treatments . 24
23 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from mechanical forces. 25
24 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by electrostatic
discharge . 27
25 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by atmospheric
pressure changes . 27
26 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from damage caused by temperature
changes . 27
ISO/DIS 14708-1
27 Protection of the ACTIVE IMPLANTABLE MEDICAL DEVICE from electromagnetic non-ionizing
radiation . 28
28 Accompanying documentation . 29
Annex A (informative) General guidance and rationale . 33
Annex B (informative) Relationship between the fundamental principles in ISO/TR 14283:2004 and the
clauses of this standard . 44
Bibliography . 62

Figures
Figure 1 – Damped sinus defibrillation waveform . 21
Figure 2 – Defibrillation test voltage generator . 21
Figure 3 – Timing sequence used for Test 1 and Test 2 . 22
Figure 4 – Test setup for truncated exponential DEFIBRILLATION waveform . 22
Figure 5 – Biphasic DEFIBRILLATION waveform for Test 2 . 23
Figure A.1 – RLC implementation for generating a damped sinus defibrillation waveform . 39
Figure A.2 – Positioning and scanning the ultrasound field exposure upon the implantable part . 41
Tables
Table 1 – Timing parameters of test signal for Test 2 . 22

iv © ISO 2013 – All rights reserved

ISO/DIS 14708-1
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 14708-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 6,
Active implants in collaboration with the CEN/CENELEC Joint Working Group on active implantable medical
devices.
This second edition cancels and replaces the first edition, which has been technically revised.
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)
 Part 7: Particular requirements for cochlear implant systems
ISO/DIS 14708-1
Introduction
This International Standard specifies general requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES to provide
basic assurance of safety for both patients and users.
To minimize the likelihood of a device being misused, this standard also details comprehensive requirements
for MARKINGS and for other information to be supplied as part of the documentation with any ACTIVE
IMPLANTABLE MEDICAL DEVICE.
For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICE, the general requirements can be supplemented or
modified by the requirements of particular standards as separate parts of ISO 14708. A requirement of such a
particular standard takes priority over the corresponding requirement of this general standard. Where
particular standards exist, this general standard should not be used alone. Special care is required when
applying this general standard alone to ACTIVE IMPLANTABLE MEDICAL DEVICES for which no particular standard
has yet been published.
vi © ISO 2013 – All rights reserved

DRAFT INTERNATIONAL STANDARD ISO/DIS 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
1 Scope
This Part 1 of ISO 14708 specifies requirements that are generally applicable to ACTIVE IMPLANTABLE MEDICAL
DEVICES.
NOTE 1 For particular types of ACTIVE IMPLANTABLE MEDICAL DEVICES, these general requirements are supplemented or modified by the
requirements of particular standards which form additional parts of this International Standard.
The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of an ACTIVE
IMPLANTABLE MEDICAL DEVICE to show compliance.
This Part 1 of ISO 14708 is applicable not only to ACTIVE IMPLANTABLE MEDICAL DEVICES that are electrically
powered but also to those powered by other energy sources (for example by gas pressure or by springs).
This Part 1 of ISO 14708 is also applicable to some non-implantable parts and accessories of the ACTIVE
IMPLANTABLE MEDICAL DEVICES.
NOTE 2 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can 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 some requirements of non-implantable parts and accessories if they could affect the
safety or performance of the implantable device.
NOTE 3 In this International Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is
used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.
NOTE 4 The terminology used in this International Standard is intended to be consistent with the terminology of ISO/TR 14283:2004.
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 60068-2-14:2009, Environmental testing – Part 2 14: Tests – Test N: Change of temperature
IEC 60068-2-27:2008, Environmental testing – Part 2 27: Tests – Test Ea and guidance: Shock
IEC 60068-2-47:2005, Environmental testing – Part 2 47: Tests – Mounting of specimens for vibration, impact
and similar dynamic tests
IEC 60068-2-64:2008, Environmental testing – Part 2 64: Tests – Test Fh: Vibration, broadband random and
guidance
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance
Amendment 1 (2012)
ISO/DIS 14708-1
IEC 60601-1-2:2007, Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 62127-1:2007, Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical
ultrasonic fields up to 40 MHz
IEC 62304:2006, Medical devices software – Software life-cycle processes
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
ISO 10993-1:2009, Biological testing of medical devices – Part 1: Evaluation and testing within a risk
management process
ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14155:2011, Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 14971:2007, Medical devices – Application of risk management to medical devices
ISO 8601:2004, Data elements and interchange formats – Information interchange – Representation of dates
and times
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
ACTIVE MEDICAL DEVICE
MEDICAL DEVICE relying for its functioning on a source of electrical energy or any source of power other than
that directly generated by the human body or gravity
3.2
ACTIVE IMPLANTABLE MEDICAL DEVICE
ACTIVE MEDICAL DEVICE which is intended to be totally or partially introduced, surgically or medically, into the
human body or by medical intervention into a natural orifice, and which is intended to remain after the
procedure
Note 1 to entry: For purposes of this Part 1 of ISO 14708, an ACTIVE IMPLANTABLE MEDICAL DEVICE can be a single ACTIVE MEDICAL
DEVICE, or a system consisting of a set of components and accessories, including software, which interact to achieve the performance
intended by the MANUFACTURER. Not all of these components or accessories may be required to be partially or totally implanted.
3.3
AUTHORIZED REPRESENTATIVE
means any natural or legal person established in the European Community who, explicitly designated by the
MANUFACTURER, acts and may be addressed by authorities and bodies in the Community instead of the
MANUFACTURER with regard to the latter's obligations
3.4
BEGINNING OF SERVICE
BOS
when an individual ACTIVE IMPLANTABLE MEDICAL DEVICE is first released by the MANUFACTURER as fit for placing
on the market
2 © ISO 2013 – All rights reserved

ISO/DIS 14708-1
3.5
CATHETER
flexible tube allowing access to a point within the body at its distal end through a lumen, often for delivering a
substance
Note 1 to entry: A CATHETER may be combined with a LEAD.
3.6
CORRECT USE
NORMAL USE without USE ERROR
[SOURCE: IEC 62366:2007, 3.7]
3.7
END OF SERVICE
EOS
when the PROLONGED SERVICE PERIOD has elapsed and performance to design specification cannot be assured
3.8
HAND HELD
term referring to part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be supported by the hand during
NORMAL USE
[SOURCE: IEC 60601-1:2006 + A1:2012, 3.37, modified — 'Electrical equipment' replaced by 'part of an
ACTIVE IMPLANTABLE MEDICAL DEVICE'.]
3.9
HARM
physical injury or damage to health of people, or damage to property or the environment
[SOURCE: ISO 14971:2007, 2.2]
3.10
HAZARD
potential source of HARM
[SOURCE: ISO 14971:2007, 2.3]
3.11
LABEL
area bearing a MARKING, affixed to an ACTIVE IMPLANTABLE MEDICAL DEVICE or package but not an integral part
of the ACTIVE IMPLANTABLE MEDICAL DEVICE or package
3.12
LEAD
flexible tube enclosing one or more insulated electrical conductors, intended to transfer electrical energy along
its length
Note 1 to entry: A LEAD may be combined with a CATHETER.
3.13
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging and labelling of an ACTIVE
IMPLANTABLE MEDICAL DEVICE before it is placed on the market under his own name, regardless of whether
these operations are carried out by that person himself or on his behalf by a third party
Note 1 to entry: This definition also applies to the natural or legal person who assembles, packages, PROCESSES, fully refurbishes and/or
labels one or more ready-made products and/or assigns to them their intended purpose as an ACTIVE IMPLANTABLE MEDICAL DEVICE with a
view to their being placed on the market under his own name. This definition also applies to the MANUFACTURER of non-implantable parts
and accessories of the ACTIVE IMPLANTABLE MEDICAL DEVICE.
ISO/DIS 14708-1
3.14
MARKING
inscription on a device, package, or LABEL
3.15
MEDICAL DEVICE
any instrument, apparatus, appliance, software, material or other article, whether used alone or in
combination, together with any accessories, including the software intended by its MANUFACTURER to be used
specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by
the MANUFACTURER to be used for human beings for the purpose of
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
3.16
MEDICINAL SUBSTANCE
any substance or combination of substances presented as having properties for treating or preventing disease
in human beings; or any substance or combination of substances which may be used in or administered to
human beings either with a view to restoring, correcting or modifying physiological functions by exerting a
pharmacological, immunological or metabolic action, or to making a medical diagnosis
Note 1 to entry: Based on Article 1 of Directive 2001/83/EC.
3.17
MEDICINAL SUBSTANCE DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA
MEDICINAL SUBSTANCES based on blood constituents which are prepared industrially by public or private
establishments, such MEDICINAL SUBSTANCES including, in particular, albumin, coagulating factors and
immunoglobulins of human origin
3.18
NON-REUSABLE PACK
single use pack designed to allow the contents to be sterilized and to maintain that sterility
3.19
NORMAL USE
operation, including routine inspection and adjustments by any user, and stand-by, according to the
instructions for use or in accordance with generally accepted practice for those MEDICAL DEVICES provided
without instructions for use
Note 1 to entry: USE ERROR can occur in NORMAL USE.
Note 2 to entry: MEDICAL DEVICES that can be used safely without instructions for use are exempted from having instructions for use by
some authorities with jurisdiction.
4 © ISO 2013 – All rights reserved

ISO/DIS 14708-1
[SOURCE: IEC 60601-1:2006, 3.71, modified — 'Operator' replaced by 'user' and 'or in accordance with
generally accepted practice for those MEDICAL DEVICES provided without instructions for use' added to the end
of the definition.]
3.20
PORTABLE
term referring to part of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to be moved from one location to
another while being carried by one or more persons
[SOURCE: IEC 60601-1:2006 + A1:2012, 3.85, modified — 'Transportable equipment' replaced by 'part of an
ACTIVE IMPLANTABLE MEDICAL DEVICE'.]
3.21
PROCESS
set of inter-related or interacting resources and activities which transform inputs into outputs
[SOURCE: ISO 14971:2007, 2.130]
3.22
PROLONGED SERVICE PERIOD
PSP
period during which the ACTIVE IMPLANTABLE MEDICAL DEVICE continues to function as defined by the
MANUFACTURER beyond the RECOMMENDED REPLACEMENT TIME
3.23
RADIOACTIVE SUBSTANCE
any substance that contains one or more radionuclides the activity or concentration of which cannot be
disregarded as far as radiation protection is concerned
Note 1 to entry: Based on 96/29/Euratom.
3.24
RECOMMENDED REPLACEMENT TIME
RRT
when the power source indicator reaches the value set by the MANUFACTURER of the
ACTIVE IMPLANTABLE MEDICAL DEVICE for its recommended replacement
Note 1 to entry: This indicates entry into the PROLONGED SERVICE PERIOD.
3.25
RESIDUAL RISK
RISK remaining after RISK CONTROL measures have been taken
[SOURCE: ISO 14971:2007, 2.15]
3.26
RISK
combination of the probability of occurrence of HARM and the severity of that HARM
[SOURCE: ISO 14971:2007, 2.16]
3.27
RISK ANALYSIS
systematic use of available information to identify HAZARDS and to estimate the RISK
Note 1 to entry: RISK ANALYSIS includes examination of different sequences of events that can produce hazardous situations and HARM.
See Annex E [of ISO 14971:2007].
[SOURCE: ISO 14971:2007, 2.17]
ISO/DIS 14708-1
3.28
RISK ASSESSMENT
overall PROCESS comprising a RISK ANALYSIS and a RISK EVALUATION
[SOURCE: ISO 14971:2007, 2.18]
3.29
RISK CONTROL
PROCESS in which decisions are made and measures implemented by which RISKS are reduced to, or
maintained within, specified levels
[SOURCE: ISO 14971:2007, 2.19]
3.30
RISK EVALUATION
PROCESS of comparing the estimated RISK against given RISK criteria to determine the acceptability of the RISK
[SOURCE: ISO 14971:2007, 2.21]
3.31
RISK MANAGEMENT
systematic application of management policies, procedures and practices to the tasks of analysing,
evaluating, controlling and monitoring RISK
[SOURCE: ISO 14971:2007, 2.22]
3.32
RISK MANAGEMENT FILE
set of records and other documents that are produced by RISK MANAGEMENT
[SOURCE: ISO 14971:2007, 2.23]
3.33
SALES PACKAGING
packaging that protects and identifies the ACTIVE IMPLANTABLE MEDICAL DEVICE during storage and handling by
the purchaser
Note 1 to entry: The SALES PACKAGING may be enclosed in further packaging, for example, a 'shipping package', for delivery.
3.34
SEALED SOURCE
source containing RADIOACTIVE SUBSTANCES whose structure is such as to prevent, under normal conditions of
use, any dispersion of the RADIOACTIVE SUBSTANCES into the environment
Note 1 to entry: Based on 96/29/Euratom.
3.35
STERILE PACK
NON-REUSABLE PACK in which the contents have been sterilized
3.36
USABILITY
characteristic of the user interface that establishes EFFECTIVENESS, EFFICIENCY, ease of user learning and user
satisfaction
[SOURCE: IEC 62366:2007, 3.17]
6 © ISO 2013 – All rights reserved

ISO/DIS 14708-1
3.37
USABILITY ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other characteristics related to the
design of tools, devices, systems, tasks, jobs, and environments to achieve adequate USABILITY
[SOURCE: IEC 62366:2007, 3.18]
3.38
USE ERROR
act or omission of an act that results in a different ACTIVE IMPLANTABLE MEDICAL DEVICE response than intended
by the MANUFACTURER or expected by the user
Note 1 to entry: USE ERROR includes slips, lapses, and mistakes.
Note 2 to entry: An unexpected physiological response of the patient is not in itself considered USE ERROR.
[SOURCE: IEC 62366:2007, 3.21, modified — 'MEDICAL DEVICE' replaced by 'ACTIVE IMPLANTABLE MEDICAL
DEVICE'.]
3.39
VALIDATION
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or
application have been fulfilled
[SOURCE: IEC 62366:2007, 3.26]
4 Symbols and abbreviations (optional)
When appropriate, symbols, abbreviated terms and identification colour may be used in the MARKINGS and
accompanying documentation of an ACTIVE IMPLANTABLE MEDICAL DEVICE. Symbols, abbreviated terms and
identification colour shall conform to harmonized standards (e.g. ISO 15223-1). Where no harmonized
standard exists, the symbols, abbreviated terms and identification colour shall be described in the
accompanying documentation.
Compliance is checked by inspection.
NOTE Symbols for use with particular ACTIVE IMPLANTABLE MEDICAL DEVICES can be specified in subsequent parts of ISO 14708.
5 General requirements for ACTIVE IMPLANTABLE MEDICAL DEVICES
5.1 General requirements for non-implantable parts
The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE which is connected to or equipped with an
electrical power source shall comply with the appropriate requirements of IEC 60601-1:2006 + A1:2012, as
determined in the RISK ANALYSIS, unless a requirement in that standard is superseded by a requirement in this
or other parts of ISO 14708.
NOTE Other subclauses in this standard require compliance with some subclauses of IEC 60601-1:2006 + A1:2012 even for non-
implantable parts that are not electrically powered.
Compliance is checked by assessment of the test report and the RISK ANALYSIS provided by the
MANUFACTURER.
ISO/DIS 14708-1
5.2 General requirements for software
Software of an ACTIVE IMPLANTABLE MEDICAL DEVICE or software that falls within the definition of an ACTIVE
IMPLANTABLE MEDICAL DEVICE shall be designed according to software life cycle process activities compliant
with IEC 62304 and validated.
Compliance is checked by assessment of the software life cycle PROCESS as required by IEC 62304:2006, 1.4
and assessment of the VALIDATION report provided by the MANUFACTURER.
5.3 USABILITY of non-implantable parts
5.3.1 USABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE connected to or
equipped with a electrical power source
The MANUFACTURER shall address in a USABILITY ENGINEERING PROCESS the RISK of poor USABILITY, including
those associated with identification, MARKING and documents
Compliance is checked by assessment of the MANUFACTURER documentations that the acceptance criteria of
the USABILITY VALIDATION plan have been met (see IEC 62366:2007, 5.9).
5.3.2 USABILITY of non-implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE not connected to or
equipped with a electrical power source
The non-implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall provide adequately USABILITY such
that the RISKS resulting from CORRECT USE and USE ERRORS are acceptable.
Compliance is checked by assessment of the MANUFACTURER documentations that the acceptance criteria of
the USABILITY VALIDATION plan have been met (see IEC 62366:2007, 5.9).
5.4 Data security and protection from HARM caused by unauthorized information tampering
When communication with the implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE through wireless
communication channels is provided, the MANUFACTURER shall provide appropriate mechanisms, interlocks
and protocols for protection against unauthorized information tampering causing damage to the implantable
parts of the ACTIVE IMPLANTABLE MEDICAL DEVICE, and/or resulting in an unacceptable RISK for the patient.
Compliance is checked by the inspection of the RISK MANAGEMENT FILE.
5.5 General requirements for RISK MANAGEMENT
5.5.1 RISK MANAGEMENT policy
The MANUFACTURER shall define and document a policy for determining acceptable RISK and the acceptability
of the RESIDUAL RISK(S) as required in ISO 14971.
Compliance is checked by inspection of the MANUFACTURER'S policy for determining criteria for RISK
acceptability.
5.5.2 RISK MANAGEMENT FILE
The MANUFACTURER shall establish and maintain a RISK MANAGEMENT FILE complying with those requirements
of ISO 14971 necessary to satisfy the requirements of this standard.
Compliance is checked by confirming the existence of an index containing references or pointers to the RISK
MANAGEMENT documentation required by this standard.
8 © ISO 2013 – All rights reserved

ISO/DIS 14708-1
5.5.3 RISK MANAGEMENT PLAN
The MANUFACTURER shall establish and maintain a RISK MANAGEMENT PLAN complying with the relevant
requirements of ISO 14971 except those related to collection and review of production and post-production
information. The RISK MANAGEMENT PLAN shall be part of the RISK MANAGEMENT FILE.
Compliance is checked by inspection of the RISK MANAGEMENT PLAN.
5.5.4 RISK MANAGEMENT PROCESS
For the purposes of this standard, the RISK MANAGEMENT PROCESS shall include the following elements:
a) RISK ANALYSIS;
b) RISK EVALUATION; and
c) RISK CONTROL.
These elements of the RISK MANAGEMENT PROCESS shall be performed in accordance with ISO 14971.
Compliance is checked by confirming that the MANUFACTURER has a RISK MANAGEMENT policy conforming with
5.5.1 and has prepared the following for the particular ACTIVE IMPLANTABLE MEDICAL DEVICE under
consideration:
– a RISK MANAGEMENT PLAN conforming with 5.5.3; and
– a RISK MANAGEMENT FILE containing the RISK MANAGEMENT documentation required by this standard.
5.6 Misconnection of parts of the ACTIVE IMPLANTABLE MEDICAL DEVICE
If misconnection presents an unacceptable RISK, the design and construction of the ACTIVE IMPLANTABLE
MEDICAL DEVICE shall prevent misconnection, unless it is not feasible in which case, appropriate MARKINGS,
warnings and instructions shall be provided.
Compliance is checked by inspection of the RISK ASSESSMENT and, if necessary, by inspection of the MARKINGS,
warnings and instructions.
6 Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES
Requirements for particular ACTIVE IMPLANTABLE MEDICAL DEVICES are not detailed in this part of ISO 14708, but
they may be specified in subsequent parts of ISO 14708.
7 General arrangement of the packaging
7.1 Implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES shall be supplied in a NON-REUSABLE PACK (see
14.1).
NOTE The NON-REUSABLE PACK is designed to be sealed yet allow its contents to be sterilized by the MANUFACTURER.
Compliance is checked by inspection.
7.2 The NON-REUSABLE PACK shall be enclosed in the SALES PACKAGING.
Compliance is checked by inspection.
ISO/DIS 14708-1
8 General MARKINGS for ACTIVE IMPLANTABLE MEDICAL DEVICES
NOTE Any MARKING required by this Part 1 of ISO 14708, in either figures or letters, can be expressed using appropriate symbols
specified in relevant International Standards, e.g. ISO 15223-1. (See also Clauses 4, 9, 11 and 13.)
8.1 Any warnings required by this Part 1 of ISO 14708 shall be prominently displayed.
Compliance is checked by inspection.
8.2 Implanted parts of ACTIVE IMPLANTABLE MEDICAL DEVICES and components of those parts shall be
identified in such a way as to allow any necessary measure to be taken following the discovery of an
unacceptable RISK in connection with any implanted part.
Compliance is checked by inspection of the MANUFACTURER'S explanation of the relationship between the
identity of the ACTIVE IMPLANTABLE MEDICAL DEVICE and the identities of its component parts.
Any warnings required by this Part 1 of ISO 14708 shall be prominently displayed.
Compliance is checked by inspection.
9 MARKINGS on the SALES PACKAGING
NOTE The SALES PACKAGING can be required to carry other regulatory MARKINGS, such as the CE mark of conformity and identification
of the notified body authorizing the mark.
9.1 If the SALES PACKAGING contains any RADIOACTIVE SUBSTANCE, it shall have MARKINGS that state the type
and activity of the RADIOACTIVE SUBSTANCE.
Compliance is checked by inspection.
9.2 The SALES PACKAGING shall bear the name and full address of the MANUFACTURER.
Compliance is checked by inspection.
9.3 The SALES PACKAGING shall bear a description of the ACTIVE IMPLANTABLE MEDICAL DEVICE (e.g. cardiac
pulse generator), the model designation and, if applicable, the batch number or the serial number of the
ACTIVE IMPLANTABLE MEDICAL DEVICE.
Compliance is checked by inspection.
9.4 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear relevant
characteristics for its use.
Compliance is checked by inspection.
9.5 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear a
statement that the contents of the package have been sterilized.
Compliance is checked by inspection.
9.6 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the year
and month of manufacture, expressed in numerals as specified by ISO 8601:2004.
Compliance is checked by inspection.
10 © ISO 2013 – All rights reserved

ISO/DIS 14708-1
9.7 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall bear the 'use
by' date, expressed as year and month, and, if appropriate, day, in numerals as specified in ISO 8601:2004.
Compliance is checked by inspection.
9.8 The MARKINGS on the SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE
shall identify the accessories within the packaging or, if there is insufficient space on the SALES PACKAGING, the
contents shall be identified within the SALES PACKAGING.
Compliance is checked by inspection.
9.9 If the intended use of an implantable part of an ACTIVE IMPLANTABLE MEDICAL DEVICE enclosed within the
SALES PACKAGING requires that it be connected to another device or accessory not included in the pack, the
SALES PACKAGING shall identify the connector types or configurations required.
Compliance is checked by inspection.
9.10 The SALES PACKAGING of implantable parts of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall carry a clear
description of the intended use of the device, if this is not obvious from the device description as required by
9.3 and 9.4.
Compliance is checked by inspection.
9.11 The SALES PACKAGING shall bear information about any special environmental or handling constraints
(for example, protection from impact, vibration, temperature, pressure, or humidity) necessary to allow the
ACTIVE IMPLANTABLE MEDICAL DEVICE to be correctly handled and stored (see Clause 10).
Compliance is checked by inspection.
9.12 The SALES PACKAGING shall, if applicable, bear an indication that the ACTIVE IMPLANTABLE MEDICAL DEVICE
contains MEDICINAL SUBSTANCE DERIVED FROM HUMAN BLOOD OR HUMAN PLASMA.
Compliance is checked by inspection.
9.13 The SALES PACKAGING of an ACTIVE IMPLANTABLE MEDICAL DEVICE that is intended for a special purpose
shall bear an indication of the special purpose (e.g. “custom-made device” or “exclusively for clinical
investigations”).
NOTE The specific MARKING can be the subject of particular national or regional regulation.
Compliance is checked by inspection.
9.14 In cases where the MANUFACTURER is required to designate an AUTHORIZED REPRESENTATIVE the SALES
PACKAGING shall bear the name and address of the AUTHORIZED REPRESENTATIVE.
This requirement does not apply to products not intended to be placed on the European Market
Compliance is checked by inspection.
ISO/DIS 14708-1
10 Construction of the SALES PACKAGING
10.1 The SALES PACKAGING of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be constructed to protect the
device and to withstand the dropping (shock), stacking (compression), vibration and temperature that can
occur during storage or handling as specified by the MANUFACTURER.
Compliance is checked by assessment of records provided by the MANUFACTURER.
10.2 The SALES PACKAGING of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be sufficiently protected against
the effects of humidity during storage or handling to prevent visible deterioration of the packaging, MARKINGS,
LABELS or accompanying documentation.
Test: Humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative
humidity of 93 %  3 % where the SALES PACKAGE under test is located. The humidity conditions at other locations
in the chamber may vary by ± 6 %. The temperature of the air in the cabinet, at all places where the SALES
PACKAGE can be located, shall be maintained within 2 C of any convenient value T in the range of + 20 C to
+ 30 C. Before being placed in the humidity cabinet, ME EQUIPMENT or its parts are be brought to a temperature
between T and T + 4 C, and kept at this temperature for at least 4 h before the humidity treatment starts.
Keep THE SALES PACKAGE in the humidity cabinet for 48 h.
After the treatment, the SALES PACKAGE is removed from the humidity cabinet and inspected.
Compliance is checked by inspection of the packaging, MARKINGS, LABELS or accompanying documentation to
determine if there is no visible deterioration.
10.3 The MARKINGS on the SALES PACKAGING of an ACTIVE IMPLANTABLE MEDICAL DEVICE shall be indelible.
Test: The package shall be placed so that the MARKINGS under test are uppermost and in a horizontal plane.
Ten millilitres of water shall be dispensed onto the centre of the area. After one minute, the MARKINGS shall be
wiped clear of surface water using a wet, soft cloth.
Compliance is checked by inspection to determine that all MARKINGS remain clearly legible. If the MARKINGS are
on a LABEL, the adhesive fixing the LABEL shall not have loosened and the LABEL shall not have become curled
at any edge.
10.4 The SALES PACKAGING shall ensure association between the ACTIVE IMPLANTABLE MEDICAL DEVICE and the
accompanying documentation that defines the purposes and functions of the device and the conditions
qualified and specified for its implantation.
Compliance is checked by inspection.
11 MARKINGS on the STERILE PACK
11.1 The STERILE PACK shall bear the name or trade name of the MANUFACTURER, and the address (city a
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