ISO 25539-2-2020 PDF

Full title and description

ISO 25539-2:2020 — Cardiovascular implants — Endovascular devices — Part 2: Vascular stents. This international standard specifies requirements for the evaluation, nomenclature, design attributes and manufacturer information for vascular stent systems (including stents and their delivery systems) used in endovascular treatment.

Abstract

This document provides performance and testing requirements and guidance for vascular stent systems, covering mechanical and functional characteristics, information supplied by the manufacturer and guidance for developing in vitro test methods (see Annex D). It is supplemental to general implant requirements and is applicable to a range of stent types (including drug-coated and absorbable scaffolds), although it does not comprehensively cover all drug-eluting or absorbable-specific properties.

General information

• Status: Published
• Publication date: 22 September 2020
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics)
• Edition / version: Edition 3 (2020)
• Number of pages: 114

Key bibliographic and lifecycle information (edition, publication date, ICS and technical committee) are recorded on the ISO catalogue entry for ISO 25539-2:2020.

Scope

ISO 25539-2:2020 applies to vascular stents and vascular scaffolds (for example absorbable vascular scaffolds) intended to treat vascular stenoses and other vascular pathologies. The standard addresses stents used alone or with delivery systems, and it includes devices with surface modifications such as drug coatings; however, it does not comprehensively specify all requirements for drug-eluting or fully absorbable devices. Some stent configurations and uses (e.g. venous stenting, bifurcation stents, bridging stents used with endovascular prostheses) are within scope but may not have comprehensive, device-specific test methods described. The standard is supplemental to broader implant standards and to other parts of ISO 25539.

Key topics and requirements

• Definitions and nomenclature for stent systems and components.
• Design attributes and functional requirements for stents and delivery systems.
• Manufacturer information and labeling requirements (intended use, contraindications, warnings, instructions for use).
• Performance requirements and recommended in vitro test methods (mechanical performance, fatigue, deployment behavior); guidance for development of in vitro tests is provided in Annex D.
• Compatibility and requirements for balloons integral to stent systems (adds requirements beyond ISO 10555‑4 where applicable).
• Consideration of surface modifications (e.g., drug coatings) and absorbable materials — within scope but not fully comprehensive for all drug- or absorbable-specific properties.
• Notes on preclinical and clinical evaluation pathways and the relationship to ISO 25539-1 and other related standards for device-drug combinations and biocompatibility testing.

These topics reflect the standard's focus on preclinical performance, design controls and information needed for safe clinical use.

Typical use and users

Primary users of ISO 25539-2:2020 include medical device manufacturers (R&D, design and regulatory teams), test laboratories performing preclinical bench testing, notified/competent bodies and regulatory reviewers assessing conformity, and clinical engineers or interventional specialists who need to understand device specifications and performance claims. The standard is used to design test programs, prepare conformity documentation and support regulatory submissions.

Related standards

Key related documents and standards referenced in or relevant to ISO 25539-2:2020 include: ISO 25539-1 (general requirements and preclinical/clinical evaluation guidance for endovascular prostheses), ISO 14630 (general requirements for non‑active surgical implants), ISO 10555‑4 (requirements for balloon catheters), and ISO 12417‑1 (requirements for vascular device–drug combination products). For device biocompatibility and quality management, ISO 10993-series and ISO 13485 are typically applied in parallel.

Keywords

vascular stent, endovascular device, stent system, delivery system, cardiovascular implant, in vitro testing, device labeling, drug-coated stent, absorbable scaffold, ISO 25539

FAQ

Q: What is this standard?

A: ISO 25539-2:2020 is the third edition international standard that sets requirements and guidance for vascular stent systems (stents and delivery systems) used in endovascular procedures.

Q: What does it cover?

A: It covers nomenclature, design attributes, manufacturer information, and performance/testing considerations (including guidance for in vitro tests). It includes but is not exhaustive for drug-eluting or fully absorbable stents and does not replace device‑specific regulatory guidance where applicable.

Q: Who typically uses it?

A: Device manufacturers (design and regulatory teams), test laboratories, notified/competent bodies, and clinical/biomedical engineers use the standard to develop test programs, prepare documentation and evaluate device performance.

Q: Is it current or superseded?

A: ISO 25539-2:2020 is the current published edition (third edition, published September 2020) and it supersedes ISO 25539-2:2012. Standards are normally reviewed on a five‑year cycle.

Q: Is it part of a series?

A: Yes — ISO 25539 is a multi‑part series addressing endovascular prostheses; Part 1 and Part 2 (this document) provide complementary information for different device types and evaluation aspects.

Q: What are the key keywords?

A: Vascular stent, endovascular device, stent system, delivery system, vascular scaffold, drug-coated stent, absorbable scaffold, in vitro testing, device labeling.