ISO/TS 17137:2021

Overview

ISO/TS 17137:2021 - "Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants" is a Technical Specification from ISO that provides design evaluation requirements and recommendations for absorbable cardiovascular implants (fully or partially degradable devices) used in the heart and vascular system. It supplements device‑specific standards by addressing time‑dependent aspects unique to absorbable materials - degradation, absorption, particulate generation and related safety/performance considerations. The third edition (2021) updates guidance on degradation‑induced fracture, labelling, and study design.

Key Topics

The standard covers practical and technical topics essential for safe development and regulatory submission of absorbable cardiovascular devices, including:

• Scope & classification - applicability to implants in direct contact with the cardiovascular system and exclusions (e.g., procedures/devices not affecting absorption; viable cell/tissue evaluations).
• Intended clinical performance and use - documenting clinical purpose and performance requirements.
• Materials - selection and characterization of absorbable polymers/metals and their degradation behaviour.
• Packaging, labelling and sterilization - requirements for packaging, instructions for use (IFU), and sterilization considerations that affect absorption.
• Shelf‑life and ageing - real‑time and accelerated ageing approaches for absorbable devices.
• Risk management - failure modes, risk mitigation, and specific risks from degradation (e.g., particulate generation).
• Design evaluation - in vitro procedural testing, in vitro degradation testing (mechanical, cyclic fatigue, physical/chemical), imaging compatibility.
• Biological evaluation - biocompatibility, particulate assessment, sterilization effects, and combination product considerations.
• In vivo preclinical & clinical evaluation - objectives, protocol guidance, data collection and clinical investigation planning.
• Post‑market surveillance - monitoring degradation‑related performance after market introduction.
• Nomenclature - Annex A explains terms like absorb, degrade and related definitions.

Applications

ISO/TS 17137:2021 is directly applicable for:

• Medical device manufacturers designing absorbable stents, scaffolds, coatings or other cardiovascular implants.
• Regulatory affairs and quality teams preparing technical files, design dossiers, and risk assessments.
• Design and materials engineers evaluating degradation, fatigue and particle generation.
• Preclinical and clinical researchers planning animal studies and clinical investigations.
• Notified bodies and regulators assessing safety/performance of absorbable cardiovascular devices.

Related Standards

• ISO 14630 (non‑active surgical implants)
• ISO 25539 series (endovascular devices)
• ISO 10993 (biological evaluation)
• ISO 12417‑1 (device‑drug combination aspects)
• ISO 14155 (clinical investigations)
• ISO 5840, ISO 11135 (referenced for cardiac valves, sterilization)

Using ISO/TS 17137:2021 helps ensure robust evaluation of degradation behavior and clinical safety for absorbable cardiovascular implants, supporting regulatory compliance and improved patient outcomes.