ISO 12417-1:2024

Overview

ISO 12417-1:2024 - Cardiovascular implants and extracorporeal systems: Vascular device‑drug combination products - Part 1: General requirements defines safety and performance requirements for vascular device‑drug combination products (VDDCPs). It is a second‑edition international standard that supplements device‑specific and implant standards (for example ISO 14630 for non‑active surgical implants and the ISO 25539 series for endovascular devices). The standard covers both permanent and non‑permanent VDDCPs and delivery system components that are drug‑covered (e.g., drug‑coated balloons and drug‑covered guidewires). It does not provide a full pharmacological evaluation, nor does it address viable biological materials or active (powered) implants.

Key technical topics and requirements

• Intended performance and classification: Defines how to describe clinical use, primary mode of action (PMOA) and device classification relevant to safety assessment.
• Design attributes and materials: Requirements for the drug‑containing part, matrices, active pharmaceutical ingredients (APIs) and connections with absorbable components (coatings). References ISO/TS 17137 and ASTM F3036-13 for absorbable coatings.
• Design evaluation: Pre‑clinical in vitro and in vivo testing, sampling and conditioning of test samples, plus pre‑clinical reporting expectations.
• Clinical evaluation: Planning, data acquisition and reporting for clinical investigations and evaluation of device performance.
• Manufacturing and quality control: Raw material reporting, API/excipient analysis, batch release testing and manufacturing controls specific to combination products.
• Sterilization and sterilization residuals: Requirements supporting “sterile” labelling and considerations for sterilization methods (note: ethylene oxide sterilization text was revised in this edition).
• Packaging, storage and shipping: Packaging requirements and the impact of storage/shipping temperatures on product stability and drug performance.
• Information supplied by the manufacturer: Labelling, record labels and instructions for use, plus post‑market surveillance obligations.
• Annexes: Informative Annex A (potential clinical/technical events) and Annex B (national/regional submission information).

Practical applications and users

Who uses ISO 12417-1:2024:

• Medical device manufacturers developing drug‑coated balloons, drug‑coated guidewires, drug‑eluting stent delivery systems, or other VDDCPs
• Regulatory affairs and compliance teams preparing submissions and technical documentation for markets and notified bodies
• R&D, clinical teams and quality engineers planning pre‑clinical testing, clinical investigations and manufacturing controls
• Notified bodies, auditors and contract test laboratories evaluating conformity, sterilization and packaging

Practical benefits:

• Provides a structured framework for safety and performance evidence for VDDCPs
• Helps align design, testing and labelling with international expectations and regional submission considerations

Related standards

• ISO 14630 - General requirements for non‑active surgical implants
• ISO 25539 series - Requirements for endovascular devices
• ISO/TS 17137 and ASTM F3036-13 - Guidance on absorbable coatings

Keywords: ISO 12417-1:2024, vascular device‑drug combination products, VDDCPs, cardiovascular implants, drug‑coated balloons, drug‑covered guidewires, sterilization, design evaluation, manufacturing, clinical evaluation.