BSI PD ISO/TS 17137:2021 – TC

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Tracked Changes. Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants

Published By	Publication Date	Number of Pages
BSI	2021	104

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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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
60	National foreword
65	Foreword
66	Introduction
67	1 Scope 2 Normative references
68	3 Terms and definitions 4 Device design, fabrication, packaging, and use considerations 4.1 Classification
69	4.2 Intended clinical performance 4.3 Intended clinical use 4.4 Materials
70	4.5 Packaging, labelling and sterilization 4.5.1 Packaging 4.5.2 Labelling
71	4.5.3 Sterilization
72	4.6 Product shelf-life considerations 4.6.1 General information 4.6.2 Real-time aging
73	4.6.3 Accelerated aging 4.7 Risk management 4.7.1 General 4.7.2 Failure modes
74	4.7.3 Risk mitigation 4.7.4 Specific aspects for absorbable implants
75	5 Design evaluation 5.1 Evaluation overview and general considerations 5.1.1 Overview
77	5.1.2 General considerations
78	5.2 In vitro procedural evaluation 5.2.1 Summary of in vitro evaluation steps
79	5.2.2 Conditioning of test samples 5.2.3 Assessment of delivery and placement
80	5.2.4 Assessment of initial function post-deployment 5.3 In vitro degradation evaluation 5.3.1 General
81	5.3.2 Sample conditioning 5.3.3 Mechanical evaluation
82	5.3.4 Cyclic fatigue durability evaluation
83	5.3.5 Physical and chemical degradation evaluation
86	5.3.6 Imaging compatibility evaluation 5.4 Biological evaluation 5.4.1 General considerations
87	5.4.2 Particulate observation, measurement and assessment — In vivo 5.4.3 Sterilization considerations
88	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
89	5.6.2 Specific objectives
90	5.6.3 Protocol
92	5.6.4 Data collection 5.6.5 Test report and additional information
93	5.7 Clinical evaluation 5.7.1 Purpose 5.7.2 Specific objectives
94	5.7.3 Clinical investigation plan (CIP)
95	5.7.4 Data collection 5.7.5 Final report 5.8 Post-market surveillance 5.9 Select clinical trials of absorbable cardiovascular implants
97	Annex A (informative) Explanation on nomenclature of absorb, degrade and related terms
98	Bibliography