ISO 25539-1-2017 PDF

Full title and description

Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses. This International Standard specifies requirements for the evaluation of endovascular systems (endovascular prostheses and their delivery systems), including nomenclature, design attributes, intended performance, materials, testing and information to be supplied by the manufacturer. Guidance for the development of in vitro test methods is provided in an informative annex.

Abstract

ISO 25539-1:2017 sets out safety and performance requirements and recommended preclinical evaluation methods for endovascular prostheses used to treat aneurysms, stenoses and other vascular anomalies (including some shunts). It supplements general implant requirements (for example ISO 14630) and focuses on device design attributes, bench and in vitro testing, manufacturing, sterilization/packaging and the information manufacturers must supply. The standard does not cover pharmacological aspects of drug-eluting prostheses or viable biological tissues used in prosthesis construction.

General information

• Status: Published (confirmed as current by ISO review process).
• Publication date: February 2017 (Edition 2, 2017).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 2 (2017).
• Number of pages: 122.

Key bibliographic and status details above are taken from the ISO publication record for ISO 25539-1:2017.

Scope

Applies to endovascular prostheses and associated delivery systems intended to treat arterial aneurysms, arterial stenoses and other vascular pathologies or to create shunts (for example TIPS). Some device configurations (e.g. fenestrated or branched prostheses) are within scope but not described in exhaustive test detail. The standard excludes most vascular occluders (with a limited exception for contra-lateral iliac occluders used as part of aorto‑uni‑iliac systems) and does not address pre‑deployment devices (such as balloon angioplasty per se), pharmacological aspects of drug‑coated prostheses, or viable biological tissues used in construction. Balloons used for apposition or overlap are within scope even if not integral to the prosthesis.

Key topics and requirements

• Requirements for intended performance and safe use of endovascular prostheses and delivery systems.
• Design attributes: dimensions, mechanical behaviour (radial strength, fatigue, recoil), compatibility with delivery systems and vessel anatomy.
• Materials and biocompatibility considerations (excluding comprehensive assessment of viable biological components and pharmacological coatings).
• Design evaluation: bench testing, in vitro methods and guidance for development of test methods (informative annexes).
• Manufacturing, sterilization, packaging and labelling requirements relevant to implantable endovascular prostheses.
• Information for users and manufacturers’ instructions for use (IFU), including clinical and preclinical data expectations.
• Post‑market surveillance and reporting considerations to support ongoing safety monitoring.

These topics reflect the standard’s role as a device‑specific supplement to more general implant standards (for example ISO 14630).

Typical use and users

Primary users include medical device manufacturers (design, R&D and regulatory teams), testing laboratories performing bench and simulated‑use evaluations, notified bodies / conformity assessment organizations, regulatory affairs specialists preparing submissions, and clinical teams evaluating device performance and risk. The standard is commonly referenced in regulatory and pre‑market documentation and is available through national adoption/adaptation channels (for example ANSI/AAMI adoption).

Related standards

Relevant related documents and parts of the ISO 25539 series and other standards include: ISO 25539‑2 (Vascular stents; updated edition 2020), ISO 25539‑3 (Vena cava filters; latest edition 2024), ISO 25539‑4 (application of ISO 17327‑1 for coated endovascular devices; 2021), ISO 14630 (general requirements for non‑active surgical implants), ISO 12417‑1 (vascular device‑drug combination products) and ISO/TS 17137 (absorbable implants guidance). These documents are intended to be used together where a device’s features span multiple parts of the series.

Keywords

endovascular prosthesis; stent‑graft; delivery system; endovascular device; vascular prosthesis; bench testing; in vitro tests; IFU; medical device regulation; ISO 14630.

FAQ

Q: What is this standard?

A: ISO 25539‑1:2017 is an ISO International Standard that defines requirements and recommended evaluation methods for endovascular prostheses and their delivery systems (endovascular devices used to treat aneurysms, stenoses and certain vascular anomalies).

Q: What does it cover?

A: It covers intended performance, design attributes, materials considerations (non‑viable), design evaluation (bench and in vitro testing), manufacturing, sterilization, packaging and information supplied by the manufacturer; it also provides guidance for developing in vitro test methods. It does not provide comprehensive requirements for pharmacological aspects of drug‑coated devices or viable biological materials.

Q: Who typically uses it?

A: Manufacturers (design, R&D, regulatory), test laboratories, conformity assessment bodies and regulatory reviewers use the standard as part of product development, preclinical testing and regulatory submissions; clinicians and hospital procurement teams may consult it for device specifications. The standard has also been adopted/recognized in various national contexts (for example ANSI/AAMI listings).

Q: Is it current or superseded?

A: ISO 25539‑1:2017 (Edition 2, 2017) is published and was confirmed under ISO’s review process (confirmed status after the 2022 review). It replaced the earlier 2003 edition. Users should check ISO or their national standards body for any amendments or confirmation updates.

Q: Is it part of a series?

A: Yes — ISO 25539 is a multipart series covering endovascular devices. Key companion parts include ISO 25539‑2 (vascular stents), ISO 25539‑3 (vena cava filters) and ISO 25539‑4 (coating application guidance); other standards (ISO 14630, ISO 12417‑1, ISO/TS 17137) are commonly referenced for complementary requirements.

Q: What are the key keywords?

A: Endovascular prosthesis, delivery system, stent‑graft, device performance, bench testing, in vitro methods, IFU, vascular implants.