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BSI PD ISO/TS 17137:2021

BSI PD ISO/TS 17137:2021

$189.07

Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants

Published By Publication Date Number of Pages
BSI 2021 46
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
4 Device design, fabrication, packaging, and use considerations
4.1 Classification
11 4.2 Intended clinical performance
4.3 Intended clinical use
4.4 Materials
12 4.5 Packaging, labelling and sterilization
4.5.1 Packaging
4.5.2 Labelling
13 4.5.3 Sterilization
14 4.6 Product shelf-life considerations
4.6.1 General information
4.6.2 Real-time aging
15 4.6.3 Accelerated aging
4.7 Risk management
4.7.1 General
4.7.2 Failure modes
16 4.7.3 Risk mitigation
4.7.4 Specific aspects for absorbable implants
17 5 Design evaluation
5.1 ​Evaluation overview and general considerations
5.1.1 Overview
19 5.1.2 General considerations
20 5.2 In vitro procedural evaluation
5.2.1 Summary of in vitro evaluation steps
21 5.2.2 Conditioning of test samples
5.2.3 ​Assessment of delivery and placement
22 5.2.4 ​Assessment of initial function post-deployment
5.3 In vitro degradation evaluation
5.3.1 General
23 5.3.2 Sample conditioning
5.3.3 Mechanical evaluation
24 5.3.4 Cyclic fatigue durability evaluation
25 5.3.5 Physical and chemical degradation evaluation
28 5.3.6 Imaging compatibility evaluation
5.4 Biological evaluation
5.4.1 General considerations
29 5.4.2 Particulate observation, measurement and assessment — In vivo
5.4.3 Sterilization considerations
30 5.4.4 Drug-device combination product considerations
5.5 In vitro-in vivo correlation (IVIVC)
5.6 In vivo preclinical evaluation
5.6.1 Purpose
31 5.6.2 Specific objectives
32 5.6.3 Protocol
34 5.6.4 Data collection
5.6.5 Test report and additional information
35 5.7 Clinical evaluation
5.7.1 Purpose
5.7.2 Specific objectives
36 5.7.3 Clinical investigation plan (CIP)
37 5.7.4 Data collection
5.7.5 Final report
5.8 Post-market surveillance
5.9 Select clinical trials of absorbable cardiovascular implants
39 Annex A (informative) Explanation on nomenclature of absorb, degrade and related terms
40 Bibliography

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BSI PD ISO/TS 17137:2021
$189.07