ISO/TR 18965:2025
(Main)Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems
Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems
This document illustrates the implementation of the risk management process to the total product life cycle of cardiac valve replacement and repair systems. It provides specific examples of how risk management requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems. The informative examples included herein are not exhaustive.
Dispositifs médicaux — Exemples d'application du processus de gestion des risques aux systèmes de remplacement et de réparation des valves cardiaques
General Information
Standards Content (Sample)
Technical
Report
ISO/TR 18965
First edition
Medical devices — Examples of the
2025-02
application of the risk management
process to cardiac valve
replacement and repair systems
Dispositifs médicaux — Exemples d'application du processus
de gestion des risques aux systèmes de remplacement et de
réparation des valves cardiaques
Reference number
© ISO 2025
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General risk management requirements . 1
5 Risk analysis . 2
5.1 Risk analysis process .2
5.2 Identification of intended use .2
5.3 Identification of reasonably foreseeable misuse .2
5.4 Identification of system characteristics related to safety .3
5.5 Identification of hazards, hazardous situations and associated harms .4
5.6 Risk estimation .6
5.6.1 General .6
5.6.2 Probability of occurrence classification .6
5.6.3 Bench testing (pre-clinical) data .6
5.6.4 Historical data .7
5.6.5 Expert judgment .7
5.6.6 Severity classification .8
6 Risk evaluation . 8
7 Risk control . 9
7.1 Risk control option analysis and implementation .9
7.2 Assessment of risks arising from risk control measures .10
7.3 Residual risk evaluation .10
7.4 Benefit-risk analysis .10
8 Evaluation of overall residual risk .11
9 Risk management review .11
10 Production and post-production activities .11
10.1 Clinical feedback mechanisms .11
10.2 Production feedback mechanisms . 12
10.3 How to manage risks throughout product lifecycle . 13
10.3.1 Immediate actions when risks are identified . 13
10.3.2 Assessment of change impact on clinical data . 13
11 Modified device considerations . 14
Annex A (informative) Risk assessment example template for a cardiac valve replacement
system.16
Bibliography . 19
iii
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,
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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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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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 2,
Cardiovascular implants and extracorporeal systems.
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.
iv
Introduction
Risk management is the underlying foundation of the product development process and should be considered
throughout all phases of the product development cycle. This document provides guidance to assist
manufacturers on the application of the risk management process, as described in ISO 13485 and ISO 14971,
to cardiac valve replacement and repair systems. Figure 1 demonstrates the relationship between the risk
and device standards as well as the applicable Technical Reports that support the risk management process.
v
Technical Report ISO/TR 18965:2025(en)
Medical devices — Examples of the application of the risk
management process to cardiac valve replacement and
repair systems
1 Scope
This document illustrates the implementation of the risk management process to the total product life cycle
of cardiac valve replacement and repair systems. It provides specific examples of how risk management
requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems.
The informative examples included herein are not exhaustive.
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 5840-2, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve
substitutes
ISO 5840-3, Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by
transcatheter techniques
ISO 5910, Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
ISO 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 5840-2, ISO 5840-3, ISO 5910 and
ISO 14971 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE The defined terms in ISO 5840-2, ISO 5840-3, ISO 5910 and ISO 14971 are derived as much as possible from
ISO/IEC Guide 63, which was developed specifically for the medical device sector.
4 General risk management requirements
Decisions and actions, based on the information collected and analysed by application of this document,
are described in other standards, such as ISO 13485, ISO 14971 and ISO/TR 24971, and are therefore not
included in this document. The manufacturer may be required to perform other risk management activities
to fulfil applicable regulatory requirements ISO/IEC Guide 63, for medical devices that are not discussed
in this document. While regulatory requirements are not described here, this document can be helpful
for manufacturers in fulfilling those regulatory requirements. This document uses the definition of risk
management from ISO 13485 and ISO 14971.
5 Risk analysis
5.1 Risk analysis process
The risk analysis process is defined in ISO 14971 and guidance for the application of ISO 14971 can be found
in ISO/TR 24971. Risk analysis examples are provided in this document specific to cardiac valve replacement
and repair systems. These examples are provided as an illustration of how to apply the risk management
process to these devices and are not intended to be an exhaustive list.
Inputs to the risk anal
...
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