Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

This document outlines design evaluation guidelines for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is meant to supplement device-specific standards by providing guidelines specific for absorbable implants and/or components This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of This document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant.

Implants cardiovasculaires et systèmes extracorporels — Implants cardiovasculaires absorbables

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Status
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Publication Date
03-Sep-2019
Withdrawal Date
03-Sep-2019
Current Stage
9599 - Withdrawal of International Standard
Start Date
15-Sep-2021
Completion Date
15-Sep-2021
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TECHNICAL ISO/TS
SPECIFICATION 17137
Second edition
2019-09
Cardiovascular implants and
extracorporeal systems —
Cardiovascular absorbable implants
Implants cardiovasculaires et systèmes extracorporels — Implants
cardiovasculaires absorbables
Reference number
ISO/TS 17137:2019(E)
ISO 2019
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ISO/TS 17137:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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.
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO/TS 17137:2019(E)
Contents Page

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

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

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

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

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

4 Device design, fabrication, packaging, and use considerations .......................................................................... 2

4.1 Classification ............................................................................................................................................................................................. 2

4.2 Intended clinical performance .................................................................................................................................................. 3

4.3 Intended clinical use .......................................................................................................................................................................... 3

4.4 Materials ....................................................................................................................................................................................................... 3

4.5 Packaging, labelling, and sterilization ................................................................................................................................. 4

4.5.1 Packaging................................................................................................................................................................................ 4

4.5.2 Labelling .................................................................................................................................................................................. 4

4.5.3 Sterilization .......................................................................................................................................................................... 5

4.6 Product shelf-life considerations ............................................................................................................................................ 6

4.6.1 General information ...................................................................................................................................................... 6

4.6.2 Real-time aging.................................................................................................................................................................. 7

4.6.3 Accelerated aging ............................................................................................................................................................ 7

4.7 Risk management ................................................................................................................................................................................. 7

4.7.1 General...................................................................................................................................................................................... 7

4.7.2 Failure modes ..................................................................................................................................................................... 7

4.7.3 Risk mitigation ...................................................................... ............................................................................................. 8

4.7.4 Specific aspects for absorbable implants ................................................................................................... 8

5 Design evaluation ................................................................................................................................................................................................ 8

5.1 E valuation overview and general considerations ..................................................................................................... 8

5.1.1 Overview ................................................................................................................................................................................. 8

5.1.2 General considerations ............................................................................................................................................10

5.1.3 Summary of in vitro evaluation steps ........................................................................................................11

5.2 in vitro procedural evaluation ...............................................................................................................................................12

5.2.1 Conditioning of test samples ..............................................................................................................................12

5.2.2 Assessment of delivery and placement .....................................................................................................12

5.2.3 Assessment of initial function post-deployment ..............................................................................13

5.3 in vitro degradation evaluation ............................................................................................................................................13

5.3.1 General...................................................................................................................................................................................13

5.3.2 Sample conditioning ..................................................................................................................................................14

5.3.3 Mechanical evaluation..............................................................................................................................................14

5.3.4 Cyclic fatigue durability evaluation ..............................................................................................................15

5.3.5 Physical/chemical degradation evaluation ............................................................................................15

5.3.6 Imaging compatibility evaluation ..................................................................................................................17

5.4 Biological evaluation .......................................................................................................................................................................17

5.4.1 General considerations ............................................................................................................................................17

5.4.2 Sterilization considerations ................................................................................................................................18

5.4.3 Drug-device combination product considerations ..........................................................................18

5.5 in vitro-in vivo correlation .......................................................................................................................................................19

5.6 in vivo pre-clinical evaluation ................................................................................................................................................19

5.6.1 Purpose .................................................................................................................................................................................19

5.6.2 Specific objectives ........................................................................................................................................................20

5.6.3 Protocol .................................................................................................................................................................................20

5.6.4 Data collection ................................................................................................................................................................22

5.6.5 Test report and additional information ....................................................................................................22

5.7 Clinical evaluation .............................................................................................................................................................................22

5.7.1 Purpose .................................................................................................................................................................................22

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ISO/TS 17137:2019(E)

5.7.2 Specific objectives ........................................................................................................................................................23

5.7.3 Clinical investigation plan .....................................................................................................................................23

5.7.4 Data collection ................................................................................................................................................................23

5.7.5 Final report ........................................................................................................................................................................24

5.7.6 Post market surveillance........................................................................................................................................24

Annex A (informative) Explanation on nomenclature of absorb, degrade and related terms ..............25

Bibliography .............................................................................................................................................................................................................................26

iv © ISO 2019 – All rights reserved
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ISO/TS 17137:2019(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.

This second edition cancels and replaces the first edition (ISO/TS 17137:2014), which has been

technically revised.

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 2019 – All rights reserved v
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ISO/TS 17137:2019(E)
Introduction

Absorbable cardiovascular implants are medical devices with various clinical indications for use in

the human cardiovascular blood system. An absorbable cardiovascular implant, or at least a portion

thereof, is designed to intentionally degrade over time into degradation products that are absorbed by

the body through metabolism, assimilation, and/or excretion (elimination). Such implants can be either

surgically or interventionally introduced to the site of treatment.

This document outlines requirements for intended performance, design attributes, materials, design

evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. This

document should be considered as a supplement to ISO 14630, which specifies general requirements

for the performance of non-active surgical implants. This document should also be considered as a

supplement to relevant device-specific standards such as the ISO 25539 series specifying requirements

for endovascular devices, which do not address degradation and other time dependent aspects of

absorbable implants and coatings. Additionally, this document should be considered in conjunction

with ISO 14155, which specifies proper practices in clinical investigations.

This document is not comprehensive with respect to the pharmacological evaluation of cardiovascular

absorbable implants. More detailed safety and performance requirements for pharmacological agents

included in the absorbable cardiovascular implant are described in ISO 12417-1.

Only issues related to degradation and absorption combined with the cardiovascular implant are

covered by this document. Due to the variations in the design of implants covered by this document

and in some cases due to the relatively recent development of some of these implants (e.g. absorbable

stents), acceptable standardized in vitro tests and clinical results are not always available. As further

scientific and clinical data become available, appropriate revision of this document will be necessary.

NOTE For issues related to the common mechanical function of the cardiovascular implant, the reader might

find it useful to consider a number of other international standards (see Bibliography).

vi © ISO 2019 – All rights reserved
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TECHNICAL SPECIFICATION ISO/TS 17137:2019(E)
Cardiovascular implants and extracorporeal systems —
Cardiovascular absorbable implants
1 Scope

This document outlines design evaluation guidelines for absorbable cardiovascular implants used

to treat vessels and/or the vascular space within the circulatory system, including the heart and all

vasculature. This document is meant to supplement device-specific standards by providing guidelines

specific for absorbable implants and/or components

This document is applicable to implants in direct contact with the cardiovascular system, where the

intended action is upon the circulatory system. This document does not address the specific evaluation

of issues associated with viable tissues, viable cells, and/or implants with non- viable biological materials

and their derivatives. Additionally, procedures and devices used prior to and following the introduction

of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the

scope of This document if they do not affect the absorption aspects of the implant. A cardiovascular

absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a

medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the

implant and supports the primary mode of action of the implant.

NOTE 1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g.

coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1.

NOTE 2 An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A of

this document.
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 (all parts), Cardiovascular implants — Cardiac valve prostheses
ISO 10993 (all parts), Biological evaluation of medical devices

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

validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation

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

sterile barrier systems and packaging systems

ISO 12417-1, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination

products — Part 1: General requirements

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
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ISO/TS 17137:2019(E)

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 25539 (all parts), Cardiovascular implants — Endovascular devices

ISO/TR 37137, Cardiovascular biological evaluation of medical devices —Guidance for absorbable implants

ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
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
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
absorb
absorption

action of a non-endogenous (foreign) material or substance or its degradation products

passing through or being assimilated by cells and/or tissue over time
3.2
degradation product

intermediate or final result from the physical, metabolic, and/or chemical decomposition of a material

or substance
3.3
degrade
physically, metabolically, and/or chemically decompose a material or substance
3.4
leachable

substance that can be released from a medical device or material during clinical use

Note 1 to entry: In absorbable devices, leachables can be substances released from the as-manufactured product

or substances generated and released as a consequence of its degradation (i.e degradation products).

4 Device design, fabrication, packaging, and use considerations
4.1 Classification

A cardiovascular absorbable implant is a product that accomplishes its intended clinical use and

performance through primarily physical and/or mechanical means over a defined time period. An

absorbable cardiovascular implant may also incorporate a medicinal substance. A cardiovascular

absorbable implant accomplishes its intended clinical use and is then fully or partially absorbed by the

body over a finite period of time. The implant’s temporary nature is provided by its ability to degrade

and the resulting degradation products’ ability to be metabolized, assimilated, and/or excreted

(eliminated) over time.

The manufacturer shall determine the acceptability of the product for clinical use at all stages of the

product life cycle.
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ISO/TS 17137:2019(E)
4.2 Intended clinical performance

The intended performance of an absorbable implant shall be described and documented by addressing

at least the following, with particular regard to patient’s safety:
a) intended purpose(s);
b) functional lifetime – duration of intended mechanical function;

c) in vivo longevity – approximate time to full absorption of the absorbable components; absence of

histological (physical) presence in tissue.
4.3 Intended clinical use

The intended clinical use shall, if applicable, be preferentially identified as one or more of the following:

a) abdominal aorta;
b) arterio-venous shunt for vascular access;
c) carotid artery;
d) coronary artery;
e) coronary heart chambers;
f) femoral artery;
g) iliac artery;
h) popliteal artery;
i) intra-cerebral artery;
j) renal artery;
k) thoracic aorta;
l) thoraco-abdominal aorta;
m) tibial artery;
n) heart valve;
o) venous valve;
p) other heart, arterial, or venous anatomy to be specified as appropriate.
4.4 Materials
The requirements of ISO 14630:2012, Clause 6, shall apply.

Additional testing appropriate to specific material types (e.g. metals, polymers, drugs) shall be

performed to determine material acceptability for use in the design. For example, guidance for assessing

absorbable polymeric implants can be found in ASTM F2902, with ASTM F3160 useful for absorbable

metal materials testing. In a more specific example, absorbable materials dependent on shape memory

properties should be subjected to testing that assesses transformation properties. For drug-eluting

absorbable implants, drug identity testing shall be performed, including the identification of impurities

and degradants. Electro-chemical potentials of differing metals (stents, guidewires, other accessory

devices) might require additional types of testing.
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ISO/TS 17137:2019(E)
4.5 Packaging, labelling, and sterilization
4.5.1 Packaging
4.5.1.1 General
The requirements of ISO 11607-1 and ISO 14630:2012, Clause 10 shall apply.

Each device shall be packaged in a unit container with a sterile barrier, or a combination of unit

container and an outer container. The unit container (within its outer container if applicable) may be

packaged in a shipping container during transit and storage.

The device packaging configuration should be designed to protect the implant during normal conditions

of handling, storage and transport such that device specifications are maintained. The sterile barrier

shall be maintained throughout its designated shelf-life to permit the contents to be presented for use

in an aseptic manner.
4.5.1.2 Considerations for absorbable product

For absorbable products, non-standard packaging attributes may be needed to mitigate or eliminate

the effects of environmental factors in order to maintain the physical, chemical and/or mechanical

specifications of the implant. Where the absorbable product is susceptible to hydrolytic or corrosive

degradation, consideration should be given toward the control and/or removal of moisture from the

package interior (e.g. through the use of moisture resistant packaging materials and/or desiccants).

In addition, absorbable products may also be susceptible to physical, chemical, and/or mechanical

degradation under extreme temperature conditions. For example, storage of polymeric products or

components at temperatures that approach or exceed a glass transition temperature could adversely

affect the physical and chemical state of the implant. Therefore, storage conditions should specify the

acceptable temperature range and limit the duration of packaged product exposure to elevated thermal

conditions.
4.5.2 Labelling
4.5.2.1 Label(s)

Each device shall be accompanied by one or more labels, one on each of the containers.

The requirements of ISO 14630:2012, Clause 11, shall apply, with the following information to be

supplied as part of the label(s):
a) name or trade name of the device;

b) expiration date (indication of shelf-life) and the recommended storage conditions;

c) description and/or list of the package contents;
d) size and device type, if applicable;
e) dimensions applicable for clinical use;
f) sterilization method and the notification “STERILE”, if applicable;

g) a warning against the use of the device if the package’s sterile barrier is damaged;

h) a written and/or “Do not resterilize” symbol warning against re-sterilizing and/or reusing the

device, if applicable;
i) reference to consult Instructions for Use for user information;

j) chemical nature of any storage medium in the unit container, with appropriate hazard warning.

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ISO/TS 17137:2019(E)
4.5.2.2 Instructions for use (IFU)

The requirements of ISO 14630:2012, Clause 11, shall apply together with the following information to

be included:
a) name or trade name of the device;

b) recommendations for storage; the actual modelled storage range determined to be acceptable

for the packaged device, taking into consideration the absorbable properties of the implant or

components thereof;

c) statement that the device can or cannot be re-sterilized, including the statements “STERILE”, “DO

NOT RESTERILIZE” in prominent form, if applicable;
d) the statement “SINGLE USE ONLY” in prominent form;
e) description and/or list of the package contents;
f) available models and sizes applicable for intended clinical use;

g) identification and description of the absorbable device or components thereof;

h) location of the absorbable part of the device, if only a portion of the implant is absorbable;

i) a general description of the principle of degradation along with both the expected time frame for

loss of mechanical function and absorption of the implant;
j) intended use/indications for use;
k) contraindications, warnings and precautions;

l) the potential for interaction of the absorbable material with other materials used in the handling,

preparation and implantation of the implant, considering direct contact and the effect of

procedural fluids;

m) potential adverse events, including known adverse events associated with implant (or portion

thereof) degradation and/or in vivo absorption process;

n) recommended methods for the aseptic presentation and preparation of the implant considering the

potential for interaction of the absorbable material with the environment or materials used;

o) recommended methods for preparation of the implantation site if applicable;
p) recommendations for visualization if applicable;

q) if the implant is metallic, electrically conductive, or contains metallic or electrically conductive

components, MRI safety information shall be provided, including any potential impact that an

accompanying radio frequency (RF)-induced temperature rise may have on the absorbable

properties of the implant or components thereof. Provided information may also include a post-

implantation time period after which safety MRI precautions are no longer relevant or needed;

r) date of or reference relating to the publication of the text, indicating if the text has been revised.

4.5.3 Sterilization
...

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