ISO/TS 17137:2021
(Main)Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
This document establishes design evaluation requirements and recommendations 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 intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both. 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 can 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.
Implants cardiovasculaires et systèmes extracorporels — Implants cardiovasculaires absorbables
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TECHNICAL ISO/TS
SPECIFICATION 17137
Third edition
2021-09
Cardiovascular implants and
extracorporeal systems —
Cardiovascular absorbable implants
Implants cardiovasculaires et systèmes extracorporels — Implants
cardiovasculaires absorbables
Reference number
©
ISO 2021
© 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 © ISO 2021 – All rights reserved
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. 6
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 . 9
5.1 E valuation overview and general considerations . 9
5.1.1 Overview . 9
5.1.2 General considerations .11
5.2 In vitro procedural evaluation .12
5.2.1 Summary of in vitro evaluation steps .12
5.2.2 Conditioning of test samples .13
5.2.3 Assessment of delivery and placement .13
5.2.4 Assessment of initial function post-deployment .14
5.3 In vitro degradation evaluation .14
5.3.1 General.14
5.3.2 Sample conditioning .15
5.3.3 Mechanical evaluation.15
5.3.4 Cyclic fatigue durability evaluation .16
5.3.5 Physical and chemical degradation evaluation.17
5.3.6 Imaging compatibility evaluation .20
5.4 Biological evaluation .20
5.4.1 General considerations .20
5.4.2 Particulate observation, measurement and assessment — In vivo .21
5.4.3 Sterilization considerations .21
5.4.4 Drug-device combination product considerations .22
5.5 In vitro-in vivo correlation (IVIVC) .22
5.6 In vivo preclinical evaluation .22
5.6.1 Purpose .22
5.6.2 Specific objectives .23
5.6.3 Protocol .24
5.6.4 Data collection .26
5.6.5 Test report and additional information .26
5.7 Clinical evaluation .27
5.7.1 Purpose .27
5.7.2 Specific objectives .27
5.7.3 Clinical investigation plan (CIP) .28
5.7.4 Data collection .29
5.7.5 Final report .29
5.8 Post-market surveillance .29
5.9 Select clinical trials of absorbable cardiovascular implants .29
Annex A (informative) Explanation on nomenclature of absorb, degrade and related terms .31
Bibliography .32
iv © ISO 2021 – All rights reserved
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 third edition cancels and replaces the second edition (ISO/TS 17137:2019), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— considerations have been added to multiple clauses regarding degradation-induced device fracture
and the generation of absorbable particulate matter after mechanical attributes are lost;
— clauses about labelling and instructions for use (IFU) have been modified;
— Figure 2 has been modified to facilitate translation into multiple languages;
— standards with guidance for charac
...
TECHNICAL ISO/TS
SPECIFICATION 17137
Third edition
2021-09
Cardiovascular implants and
extracorporeal systems —
Cardiovascular absorbable implants
Implants cardiovasculaires et systèmes extracorporels — Implants
cardiovasculaires absorbables
Reference number
©
ISO 2021
© 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 © ISO 2021 – All rights reserved
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. 6
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 . 9
5.1 E valuation overview and general considerations . 9
5.1.1 Overview . 9
5.1.2 General considerations .11
5.2 In vitro procedural evaluation .12
5.2.1 Summary of in vitro evaluation steps .12
5.2.2 Conditioning of test samples .13
5.2.3 Assessment of delivery and placement .13
5.2.4 Assessment of initial function post-deployment .14
5.3 In vitro degradation evaluation .14
5.3.1 General.14
5.3.2 Sample conditioning .15
5.3.3 Mechanical evaluation.15
5.3.4 Cyclic fatigue durability evaluation .16
5.3.5 Physical and chemical degradation evaluation.17
5.3.6 Imaging compatibility evaluation .20
5.4 Biological evaluation .20
5.4.1 General considerations .20
5.4.2 Particulate observation, measurement and assessment — In vivo .21
5.4.3 Sterilization considerations .21
5.4.4 Drug-device combination product considerations .22
5.5 In vitro-in vivo correlation (IVIVC) .22
5.6 In vivo preclinical evaluation .22
5.6.1 Purpose .22
5.6.2 Specific objectives .23
5.6.3 Protocol .24
5.6.4 Data collection .26
5.6.5 Test report and additional information .26
5.7 Clinical evaluation .27
5.7.1 Purpose .27
5.7.2 Specific objectives .27
5.7.3 Clinical investigation plan (CIP) .28
5.7.4 Data collection .29
5.7.5 Final report .29
5.8 Post-market surveillance .29
5.9 Select clinical trials of absorbable cardiovascular implants .29
Annex A (informative) Explanation on nomenclature of absorb, degrade and related terms .31
Bibliography .32
iv © ISO 2021 – All rights reserved
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 third edition cancels and replaces the second edition (ISO/TS 17137:2019), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— considerations have been added to multiple clauses regarding degradation-induced device fracture
and the generation of absorbable particulate matter after mechanical attributes are lost;
— clauses about labelling and instructions for use (IFU) have been modified;
— Figure 2 has been modified to facilitate translation into multiple languages;
— standards with guidance for charac
...
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