Cardiovascular implants — Transcatheter cardiac occluders

This document specifies important in vitro tests including functional and durability characteristics of transcatheter cardiac occluders, and their delivery systems and accessories. This document does not specify exact test methods for functional and durability testing, but it offers requirements and recommendations for performance tests of the cardiac occluder system. Surgical occluders have been omitted from the scope of this document given their significant differences in device geometry, materials, implantation methods, and test methods as compared to transcatheter cardiac occluders. This document is applicable to all intracardiac occluders intended for transcatheter implantation in humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac occluders, but elements of this document can be applicable to patent ductus arteriosus occluders. The following devices and components are outside the scope of this document: surgical devices, cardiac shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal tissue components. This document is applicable to both newly developed and modified cardiac occluders, their accessory devices, packaging, and labelling. This document defines operational conditions and performance requirements for cardiac occluders where either adequate scientific or clinical evidence, or both, exists for their justification. NOTE At the time of this document, it is impossible to take all future and emerging technologies into consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in order to verify and validate these cardiac occluder systems.

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Status
Published
Publication Date
28-Nov-2021
Current Stage
6060 - International Standard published
Start Date
29-Nov-2021
Completion Date
29-Nov-2021
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INTERNATIONAL ISO
STANDARD 22679
First edition
2021-11
Cardiovascular implants —
Transcatheter cardiac occluders
Reference number
ISO 22679:2021(E)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO 22679:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22679:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction .............................................................................................................................................................................................................................. vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 2

4 Abbreviations .......................................................................................................................................................................................................... 6

5 Fundamental requirements ..................................................................................................................................................................... 7

5.1 General ........................................................................................................................................................................................................... 7

5.2 Risk management ................................................................................................................................................................................. 7

6 Device description .............................................................................................................................................................................................8

6.1 General ........................................................................................................................................................................................................... 8

6.2 Intended use ............................................................................................................................................................................................. 8

6.3 Design inputs ........................................................................................................................................................................................... 8

6.3.1 Operational principles and specifications ................................................................................................... 8

6.3.2 Functional, performance and safety requirements ............................................................................ 8

6.3.3 Implant procedure: Device and usability requirements ................................................................. 9

6.3.4 Packaging, labelling and sterilization .......................................................................................................... 10

6.4 Design outputs ..................................................................................................................................................................................... 10

6.5 Design transfer (manufacturing verification or validation) ....................................................................... 10

7 Design verification and validation ................................................................................................................................................10

7.1 General requirements ................................................................................................................................................................... 10

7.2 In vitro assessment.......................................................................................................................................................................... 11

7.2.1 General ..................................................................................................................................................................................... 11

7.2.2 Test conditions, sample selection and reporting requirements ........................................... 11

7.2.3 Material property assessment ............................................................................................................................12

7.2.4 Structural performance assessment ............................................................................................................. 13

7.2.5 Component corrosion assessment ................................................................................................................... 14

7.2.6 Visibility .................................................................................................................................................................................. 14

7.2.7 Visual inspection ............................................................................................................................................................. 15

7.2.8 Dimensional verification .......................................................................................................................................... 15

7.2.9 Device MRI compatibility ........................................................................................................................................ 15

7.2.10 Simulated use assessment ...................................................................................................................................... 15

7.2.11 Usability engineering process ............................................................................................................................. 15

7.2.12 Design- or procedure-specific testing .......................................................................................................... 15

7.3 Preclinical in vivo evaluation .................................................................................................................................................15

7.3.1 General .....................................................................................................................................................................................15

7.3.2 Overall requirements ..................................................................................................................................................15

7.3.3 Methods ................................................................................................................................................................................... 17

7.3.4 Test report ............................................................................................................................................................................. 18

7.4 Clinical investigations ................................................................................................................................................................... 19

7.4.1 General ..................................................................................................................................................................................... 19

7.4.2 Study considerations ...................................................................................................................................................20

7.4.3 Imaging assessment ..................................................................................................................................................... 21

7.4.4 Study design ........................................................................................................................................................................ 21

7.4.5 Explant analysis ............................................................................................................................................................... 21

7.4.6 Pilot study considerations ...................................................................................................................................... 22

7.4.7 Study endpoints................................................................................................................................................................ 22

7.4.8 Ethical considerations ................................................................................................................................................ 22

7.4.9 Pivotal studies: Distribution of subjects and investigators ......................................................23

7.4.10 Site qualification and training requirements ........................................................................................ 23

7.4.11 Study population ............................................................................................................................................................. 23

7.4.12 Statistical considerations ........................................................................................................................................ 24

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 22679:2021(E)

7.4.13 Sample size ........................................................................................................................................................................... 25

7.4.14 Duration of study ............................................................................................................................................................ 25

7.4.15 Patient selection criteria .......................................................................................................................................... 25

7.4.16 Clinical data requirements ..................................................................................................................................... 26

Annex A (informative) Rationale for the provisions of this document ........................................................................31

Annex B (informative) Transcatheter cardiac occluder hazard analysis example ........................................34

Annex C (normative) Packaging ............................................................................................................................................................................36

Annex D (normative) Product labels and instructions for use .............................................................................................37

Annex E (normative) Sterilization .......................................................................................................................................................................38

Annex F (informative) Corrosion assessment .........................................................................................................................................39

Annex G (informative) In vitro test guidelines for paediatric devices .........................................................................42

Annex H (informative) Fatigue and durability assessment ..................................................................................................... 44

Annex I (normative) Adverse event classification during clinical investigation ..............................................50

Annex J (informative) Imaging protocol .......................................................................................................................................................55

Annex K (informative) Clinical investigation endpoints for transcatheter cardiac occluders:

Suggestions for endpoints and their timing ........................................................................................................................56

Annex L (informative) Examples of design specific testing .....................................................................................................59

Annex M (informative) Guidelines for delivery system design evaluation .............................................................61

Annex N (normative) Preclinical in vivo evaluation ........................................................................................................................63

Annex O (informative) In vitro test pressure guidelines ............................................................................................................66

Annex P (informative) Training for physicians and support staff ....................................................................................68

Bibliography .............................................................................................................................................................................................................................69

© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22679:2021(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 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.
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
ISO 22679:2021(E)
Introduction

The field of transcatheter cardiac occluders has advanced and expanded significantly in recent

years. Therefore, a group of engineers, scientists, and clinicians, experts well aware of the problems

associated with transcatheter cardiac occluder devices and their development, has prepared this

document. This document deals with those areas that will help ensure adequate mitigation of device-

associated risks for patients and other users of the device, facilitate quality assurance, and help ensure

that the device will be provided in a convenient and usable form. This document emphasizes the need

to specify and report types of in vitro testing, preclinical in vivo, and clinical evaluations. It describes

the requirements for labels and packaging of the device. The in vitro, preclinical in vivo, and clinical

evaluations described in this document are intended to help establish safety and performance of a

transcatheter cardiac occluder.

This document outlines an approach for minimizing adverse events from the implantation of a

transcatheter cardiac occluder through risk management. The selection of appropriate verification

or validation tests and methods are derived from the risk assessment and design input requirements.

The tests include those to assess the physical, mechanical, chemical, and biological properties of

transcatheter cardiac occluders and of their materials and components. The tests also include those for

preclinical in vivo evaluation and clinical evaluation of the transcatheter cardiac occluders.

© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD ISO 22679:2021(E)
Cardiovascular implants — Transcatheter cardiac
occluders
1 Scope

This document specifies important in vitro tests including functional and durability characteristics

of transcatheter cardiac occluders, and their delivery systems and accessories. This document does

not specify exact test methods for functional and durability testing, but it offers requirements and

recommendations for performance tests of the cardiac occluder system.

Surgical occluders have been omitted from the scope of this document given their significant differences

in device geometry, materials, implantation methods, and test methods as compared to transcatheter

cardiac occluders.

This document is applicable to all intracardiac occluders intended for transcatheter implantation in

humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left

atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac

occluders, but elements of this document can be applicable to patent ductus arteriosus occluders.

The following devices and components are outside the scope of this document: surgical devices, cardiac

shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal

tissue components.

This document is applicable to both newly developed and modified cardiac occluders, their accessory

devices, packaging, and labelling.

This document defines operational conditions and performance requirements for cardiac occluders

where either adequate scientific or clinical evidence, or both, exists for their justification.

NOTE At the time of this document, it is impossible to take all future and emerging technologies into

consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based

on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in

order to verify and validate these cardiac occluder systems.
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 10555-1, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk

management process

ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements

ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires

ISO 11135-1, Sterilization of health care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

© ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 22679:2021(E)

ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of

development, validation and routine control

ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,

sterile barrier systems and packaging systems

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for

forming, sealing and assembly processes

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14630, Non-active surgical implants — General requirements

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with information to be supplied by the manufacturer

— Part 1: General requirements

ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information

to be supplied — Part 2: Symbol development, selection and validation

ISO 17664-1, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO/TS 17665-2, Sterilization of health care products — Moist heat — Part 2: Guidance on the application

of ISO 17665-1

ISO/TS 17665-3, Sterilization of health care products — Moist heat — Part 3: Guidance on the designation

of a medical device to a product family and processing category for steam sterilization

ISO 20417, Medical devices — Information to be supplied by the manufacturer

ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk

management

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

ASTM F2052, Standard test method for measurement of magnetically induced displacement force on

medical devices in the magnetic resonance environment

ASTM F2119, Standard test method for evaluation of MR image artifacts from passive implants

ASTM F2182, Standard test method for measurement of radio frequency induced heating near passive

implants during magnetic resonance imaging

ASTM F2213, Standard test method for measurement of magnetically induced torque on medical devices in

the magnetic resonance environment

ASTM F2503, Standard practice for marking medical devices and other items for safety in the magnetic

resonance environment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
© ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
ISO 22679:2021(E)

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/
3.1
access system

system consisting of a variety of components (e.g. sheath, haemostasis control valve, side ports for

administration of physiological fluids and medications) to provide vascular access for the cardiac

occluder (3.3) delivery system (3.8)
3.2
adverse event

untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including

abnormal laboratory findings), in subjects, users or other persons, whether or not related to the

investigational medical device

Note 1 to entry: This definition includes events related to the investigational medical device or the comparator.

Note 2 to entry: This definition includes events related to the procedures involved.

Note 3 to entry: For users or other persons, this definition is restricted to events related to investigational

medical devices.
3.3
cardiac occluder

non-active (3.20) implant to occlude a specific cardiac anatomic structure (e.g. atrial septal defects,

ventricular septal defects, patent foramen ovale, left atrial appendage) or seal an abnormal site of blood

flow (e.g. heart valve substitute paravalvular leak)
3.3.1
atrial septal occluder
cardiac occluder (3.3) used to treat an atrial septal defect
3.3.2
left atrial appendage occluder
cardiac occluder (3.3) used to close the opening of the left atrial appendage
3.3.3
paravalvular leak occluder
cardiac occluder (3.3) used to close a paravalvular leak
3.3.4
patent ductus arteriosus occluder
occluder used to close a patent ductus arteriosus
3.3.5
patent foramen ovale occluder
cardiac occluder (3.3) used to close a patent foramen ovale
3.3.6
ventricular septal occluder
cardiac occluder (3.3) used to treat a ventricular septal defect
3.4
cardiac occluder system

supplied components, such as the cardiac occluder (3.3), access system (3.1), delivery system (3.8),

accessories, packaging and labelling
© ISO 2021 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 22679:2021(E)
3.5
delivery approach

anatomical access used to deliver the cardiac occluder (3.3) to the intended implant site (3.17) (e.g.

transfemoral, transseptal)
3.6
delivery catheter

component of the delivery system (3.8), used to advance and deploy a cardiac occluder (3.3) to the

intended implantation site
3.7
delivery sheath

hollow tube that traverses the skin and subcutaneous tissue and enters the endovascular space to

facilitate entry of wires and catheters
3.8
delivery system

system [e.g. delivery catheter (3.6)] used to deliver, deploy, attach or adjust [i.e. recapture (3.22) or

retrieve] a cardiac occluder (3.3) in the intended implantation site
3.9
design validation

establishment by objective evidence that device specifications conform with user needs and intended

use(s) (3.18)
3.10
design verification

establishment by objective evidence that the design output meets the design input requirements

3.11
device embolization

post-deployment or peri-procedural dislodgement of the cardiac occluder (3.3), from the implantation

site or catheter, respectively, to an unintended and non-therapeutic location via the bloodstream

3.12
device failure

inability of a cardiac occluder (3.3) to perform its intended function sufficient to cause a hazard

3.13
device migration

detectable movement or displacement of the cardiac occluder (3.3) from its original position within

close proximity of the intended implant site (3.17), without embolization
3.14
failure mode

mechanism of device failure (3.12) [e.g. catastrophic support structure fracture (3.15)]

3.15
fracture

unintentional disruption, under the action of applied load (e.g. force, torque, or deformation), of a

structural element (3.32) of the cardiac occluder system (3.4) that were previously intact

3.16
imaging modality

imaging method used to facilitate diagnosis, delivery and/or retrieval (3.24)/recapture (3.22) of the

implant within the target implant site (3.17), as well as to assess cardiac occluder (3.3) performance

after implantation
3.17
implant site
intended anatomic site of a cardiac occluder (3.3) deployment
© ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 22679:2021(E)
3.18
intended use

use of a cardiac occluder (3.3) in accordance with the specifications, instructions and information

provided by the manufacturer
3.19
membrane

flexible synthetic material covering or integrated within a portion or all of the cardiac occlude

3.20
non-active

implant which does not depend on a source of electrical energy or any source of power other than that

directly generated by the human body or gravity
3.21
protective packaging

configuration of materials designed to prevent damage to the sterile barrier system (3.31) and its

contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2019
...

INTERNATIONAL ISO
STANDARD 22679
First edition
Cardiovascular implants —
Transcatheter cardiac occluders
PROOF/ÉPREUVE
Reference number
ISO 22679:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 22679:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22679:2021(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Abbreviations........................................................................................................................................................................................................... 6

5 Fundamental requirements ...................................................................................................................................................................... 7

5.1 General ........................................................................................................................................................................................................... 7

5.2 Risk management ................................................................................................................................................................................. 7

6 Device description .............................................................................................................................................................................................. 8

6.1 General ........................................................................................................................................................................................................... 8

6.2 Intended use .............................................................................................................................................................................................. 8

6.3 Design inputs ............................................................................................................................................................................................ 8

6.3.1 Operational principles and specifications ................................................................................................. 8

6.3.2 Functional, performance and safety requirements ............................................................................ 8

6.3.3 Implant procedure: Device and usability requirements ................................................................ 9

6.3.4 Packaging, labelling and sterilization .........................................................................................................10

6.4 Design outputs .....................................................................................................................................................................................10

6.5 Design transfer (manufacturing verification or validation) .........................................................................10

7 Design verification and validation ..................................................................................................................................................10

7.1 General requirements ....................................................................................................................................................................10

7.2 In vitro assessment ..........................................................................................................................................................................11

7.2.1 General...................................................................................................................................................................................11

7.2.2 Test conditions, sample selection and reporting requirements ..........................................11

7.2.3 Material property assessment ..........................................................................................................................12

7.2.4 Structural performance assessment ............................................................................................................13

7.2.5 Component corrosion assessment ................................................................................................................14

7.2.6 Visibility................................................................................................................................................................................14

7.2.7 Visual inspection ...........................................................................................................................................................15

7.2.8 Dimensional verification ........................................................................................................................................15

7.2.9 Device MRI compatibility ......................................................................................................................................15

7.2.10 Simulated use assessment ....................................................................................................................................15

7.2.11 Usability engineering process ...........................................................................................................................15

7.2.12 Design- or procedure-specific testing.........................................................................................................15

7.3 Preclinical in vivo evaluation ...................................................................................................................................................15

7.3.1 General...................................................................................................................................................................................15

7.3.2 Overall requirements ................................................................................................................................................15

7.3.3 Methods ................................................................................................................................................................................17

7.3.4 Test report ..........................................................................................................................................................................18

7.4 Clinical investigations ....................................................................................................................................................................19

7.4.1 General...................................................................................................................................................................................19

7.4.2 Study considerations .................................................................................................................................................20

7.4.3 Imaging assessment ...................................................................................................................................................21

7.4.4 Study design ......................................................................................................................................................................21

7.4.5 Explant analysis .............................................................................................................................................................21

7.4.6 Pilot study considerations ....................................................................................................................................22

7.4.7 Study endpoints .............................................................................................................................................................22

7.4.8 Ethical considerations ..............................................................................................................................................22

7.4.9 Pivotal studies: Distribution of subjects and investigators ......................................................23

7.4.10 Site qualification and training requirements .......................................................................................23

7.4.11 Study population ...........................................................................................................................................................23

7.4.12 Statistical considerations ......................................................................................................................................24

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO 22679:2021(E)

7.4.13 Sample size ........................................................................................................................................................................25

7.4.14 Duration of study ..........................................................................................................................................................25

7.4.15 Patient selection criteria ........................................................................................................................................25

7.4.16 Clinical data requirements ...................................................................................................................................26

Annex A (informative) Rationale for the provisions of this document ..........................................................................31

Annex B (informative) Transcatheter cardiac occluder hazard analysis example ............................................34

Annex C (normative) Packaging .............................................................................................................................................................................36

Annex D (normative) Product labels and instructions for use ...............................................................................................37

Annex E (normative) Sterilization .......................................................................................................................................................................38

Annex F (informative) Corrosion assessment ..........................................................................................................................................39

Annex G (informative) In vitro test guidelines for paediatric devices ...........................................................................42

Annex H (informative) Fatigue and durability assessment ........................................................................................................44

Annex I (normative) Adverse event classification during clinical investigation .................................................50

Annex J (informative) Imaging protocol .........................................................................................................................................................55

Annex K (informative) Clinical investigation endpoints for transcatheter cardiac occluders:

Suggestions for endpoints and their timing..........................................................................................................................56

Annex L (informative) Examples of design specific testing ........................................................................................................59

Annex M (informative) Guidelines for delivery system design evaluation ................................................................61

Annex N (normative) Preclinical in vivo evaluation ..........................................................................................................................63

Annex O (informative) In vitro test pressure guidelines ..............................................................................................................66

Annex P (informative) Training for physicians and support staff .......................................................................................68

Bibliography .............................................................................................................................................................................................................................69

iv PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22679:2021(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 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.
© ISO 2021 – All rights reserved PROOF/ÉPREUVE v
---------------------- Page: 5 ----------------------
ISO 22679:2021(E)
Introduction

The field of transcatheter cardiac occluders has advanced and expanded significantly in recent

years. Therefore, a group of engineers, scientists, and clinicians, experts well aware of the problems

associated with transcatheter cardiac occluder devices and their development, has prepared this

document. This document deals with those areas that will help ensure adequate mitigation of device-

associated risks for patients and other users of the device, facilitate quality assurance, and help ensure

that the device will be provided in a convenient and usable form. This document emphasizes the need

to specify and report types of in vitro testing, preclinical in vivo, and clinical evaluations. It describes

the requirements for labels and packaging of the device. The in vitro, preclinical in vivo, and clinical

evaluations described in this document are intended to help establish safety and performance of a

transcatheter cardiac occluder.

This document outlines an approach for minimizing adverse events from the implantation of a

transcatheter cardiac occluder through risk management. The selection of appropriate verification

or validation tests and methods are derived from the risk assessment and design input requirements.

The tests include those to assess the physical, mechanical, chemical, and biological properties of

transcatheter cardiac occluders and of their materials and components. The tests also include those for

preclinical in vivo evaluation and clinical evaluation of the transcatheter cardiac occluders.

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INTERNATIONAL STANDARD ISO 22679:2021(E)
Cardiovascular implants — Transcatheter cardiac
occluders
1 Scope

This document specifies important in vitro tests including functional and durability characteristics

of transcatheter cardiac occluders, and their delivery systems and accessories. This document does

not specify exact test methods for functional and durability testing, but it offers requirements and

recommendations for performance tests of the cardiac occluder system.

Surgical occluders have been omitted from the scope of this document given their significant differences

in device geometry, materials, implantation methods, and test methods as compared to transcatheter

cardiac occluders.

This document is applicable to all intracardiac occluders intended for transcatheter implantation in

humans (e.g. atrial septal occluder, ventricular septal occluder, patent foramen ovale occluder, left

atrial appendage occluder, and paravalvular leak occluders). This document does not cover non-cardiac

occluders, but elements of this document might be applicable to patent ductus arteriosus occluders.

The following devices and components are outside the scope of this document: surgical devices, cardiac

shunt devices, atrial flow regulators, active components (such as sensors), or degradable or animal

tissue components.

This document is applicable to both newly developed and modified cardiac occluders, their accessory

devices, packaging, and labelling.

This document defines operational conditions and performance requirements for cardiac occluders

where either adequate scientific or clinical evidence, or both, exists for their justification.

NOTE At the time of this document, it is impossible to take all future and emerging technologies into

consideration. The cardiac occluder systems based on these new technologies can benefit from evaluation based

on the basic requirements of this document. Testing beyond the scope of this document can also be necessary in

order to verify and validate these cardiac occluder systems.
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 10555-1, Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements

ISO 10993 (all parts), — Biological evaluation of medical devices
ISO 11070, Sterile single-use intravascular introducers, dilators and guidewires

ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for

development, validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of

development, validation and routine control
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ISO 22679:2021(E)

ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,

sterile barrier systems and packaging systems

ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for

forming, sealing and assembly processes

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14630, Non-active surgical implants — General requirements

ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ISO 14971, Medical devices — Application of risk management to medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information

to be supplied — Part 2: Symbol development, selection and validation

ISO 17664, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO/TS 17665-2, Sterilization of health care products — Moist heat — Part 2: Guidance on the application

of ISO 17665-1

ISO/TS 17665-3, Sterilization of health care products — Moist heat — Part 3: Guidance on the designation

of a medical device to a product family and processing category for steam sterilization

ISO 20417, Medical devices — Information to be supplied by the manufacturer

ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk

management

IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices

ASTM F2052, Standard test method for measurement of magnetically induced displacement force on

medical devices in the magnetic resonance environment

ASTM F2119, Standard test method for evaluation of MR image artifacts from passive implants

ASTM F2182, Standard test method for measurement of radio frequency induced heating near passive

implants during magnetic resonance imaging

ASTM F2213, Standard test method for measurement of magnetically induced torque on medical devices in

the magnetic resonance environment

ASTM F2503, Standard practice for marking medical devices and other items for safety in the magnetic

resonance environment
3 Terms and definitions
For the purposes of this document, the following terms and definitions 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
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ISO 22679:2021(E)
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE Additional definitions can be found in the informative annexes.
3.1
access system

system consisting of a variety of components (e.g. sheath, hemostasis control valve, side ports for

administration of physiological fluids and medications) to provide vascular access for the cardiac

occluder (3.3) delivery system (3.8)
3.2
adverse event

untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including

abnormal laboratory findings), in subjects, users or other persons, whether or not related to the

investigational medical device

Note 1 to entry: This definition includes events related to the investigational medical device or the comparator.

Note 2 to entry: This definition includes events related to the procedures involved.

Note 3 to entry: For users or other persons, this definition is restricted to events related to investigational

medical devices.
3.3
cardiac occluder

non-active (3.20) implant to occlude a specific cardiac anatomic structure (e.g. atrial septal defects,

ventricular septal defects, patent foramen ovale, left atrial appendage) or seal an abnormal site of blood

flow (e.g. heart valve substitute paravalvular leak)
3.3.1
atrial septal occluder
cardiac occluder (3.3) used to treat atrial septal defect
3.3.2
left atrial appendage occluder
cardiac occluder (3.3) used to close the opening of the left atrial appendage
3.3.3
paravalvular leak occluder
cardiac occluder (3.3) used to close a paravalvular leak
3.3.4
patent ductus arteriosus occluder
occluder used to close a patent ductus arteriosus
3.3.5
patent foramen ovale occluder
cardiac occluder (3.3) used to close a patent foramen ovale
3.3.6
ventricular septal occluder
cardiac occluder (3.3) used to treat ventricular septal defect
3.4
cardiac occluder system

supplied components, such as the cardiac occluder (3.3), access system (3.1), delivery system (3.8),

accessories, packaging, and labelling
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ISO 22679:2021(E)
3.5
delivery approach

anatomical access used to deliver the cardiac occluder (3.3) to the intended implant site (3.17) (e.g.

transfemoral, transseptal)
3.6
delivery catheter

component of the delivery system (3.8), used to advance and deploy a cardiac occluder (3.3) to the

intended implantation site
3.7
delivery sheath

hollow tube that traverses the skin and subcutaneous tissue and enters the endovascular space to

facilitate entry of wires and catheters.
3.8
delivery system

system (e.g. delivery catheter (3.6)) used to deliver, deploy, attach or adjust (i.e. recapture (3.22) or

retrieve) a cardiac occluder (3.3) in the intended implantation site
3.9
design validation

establishment by objective evidence that device specifications conform with user needs and intended

use(s) (3.18)
3.10
design verification

establishment by objective evidence that the design output meets the design input requirements

3.11
device embolization

post-deployment or peri-procedural dislodgement of the cardiac occluder (3.3), from the implantation

site or catheter, respectively, to an unintended and non-therapeutic location via the bloodstream

3.12
device failure

inability of a cardiac occluder (3.3) to perform its intended function sufficient to cause a hazard

3.13
device migration

detectable movement or displacement of the cardiac occluder (3.3) from its original position within

close proximity of the intended implant site (3.17), without embolization
3.14
failure mode

mechanism of device failure (3.12) (e.g. catastrophic support structure fracture (3.15))

3.15
fracture

unintentional disruption, under the action of applied load (e.g. force, torque, or deformation), of a

structural element (3.32) of the cardiac occluder system (3.4) that were previously intact

3.16
imaging modality

imaging method used to facilitate diagnosis, delivery and/or retrieval (3.24)/recapture (3.22) of the

implant within the target implant site (3.17), as well as to assess cardiac occluder (3.3) performance

after implantation
3.17
implant site
intended anatomic site of cardiac occluder (3.3) deployment
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ISO 22679:2021(E)
3.18
intended use

use of a cardiac occluder (3.3) in accordance with the specifications, instructions and information

provided by the manufacturer
3.19
membrane

flexible synthetic material covering or integrated within a portion or all of the cardiac occlude

3.20
non-active

implant which does not depend on a source of electrical energy or any source of power other than that

directly generated by the human body or gravity
3.21
protective packaging

configuration of materials designed to prevent damage to the sterile barrier system (3.31) and its

contents from the time of their assembly until the point of use
[SOURCE: ISO 11607-1:2018, 3.14]
3.22
recap
...

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