ISO/TS 17137:2021

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
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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
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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
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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
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expressions related to conformity assessment, as well as information about ISO's adherence to the
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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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