ISO 5910:2024

Overview

ISO 5910:2024 - "Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices" (Second edition, 2024) defines a risk‑based framework for the verification and validation of heart valve repair systems. The standard specifies how to select and justify tests and methods based on risk assessment and covers evaluations of physical, chemical, biological and mechanical properties, as well as preclinical in vivo studies and clinical investigations to demonstrate safety and effectiveness (where effectiveness includes clinical performance and benefits).

Key topics and technical requirements

• Risk management driven testing: Verification and validation activities (in vitro, preclinical, clinical) are selected according to documented risk assessment.
• Design inputs and outputs: Requirements for intended use, operational specifications, functional/performance/safety requirements, usability, packaging, labelling and sterilization.
• In vitro testing: Material properties, integrated durability/corrosion assessments, simulated use, MRI safety and device visibility considerations.
• Preclinical in vivo evaluation: Study planning, methods, reporting and additional evaluation considerations for ex vivo/in vivo models.
• Clinical investigations: Study design, endpoints (safety and effectiveness), ethical and statistical considerations, subject selection and post‑market clinical follow‑up.
• Manufacturing verification and validation: Design transfer, process validation and quality evidence for production.
• Normative and informative annexes: Guidance on packaging, labelling, sterilization, test platforms, hazard analysis, imaging, paediatric testing, durability and clinical end points.

Scope and exclusions

• Applies to heart valve repair systems intended to repair or improve native human valve function by acting on the valve apparatus or adjacent anatomy (e.g., ventricle, coronary sinus).
• Excludes CRT devices, paravalvular leakage closure devices, non‑implant procedures (e.g., ablation, RF annuloplasty), apical conduits, devices with viable cells and general surgical materials not intended for valve repair.

Practical applications - who uses ISO 5910:2024

• Medical device manufacturers developing cardiac valve repair devices and delivery systems (including transcatheter and robotically‑assisted systems).
• Regulatory and clinical affairs teams preparing preclinical and clinical evidence packages for approvals and CE/FDA submissions.
• R&D, design verification/validation and quality assurance professionals establishing test strategies, durability studies, biocompatibility and sterilization plans.
• Clinical investigators and hospitals conducting device trials and post‑market clinical follow‑up.

Related standards (context)

ISO 5910:2024 is used alongside other medical device standards and guidance covering biological evaluation, sterilization, imaging and medical device risk management. Refer to applicable national/regulatory guidance for harmonization with clinical and regulatory requirements.

Keywords: ISO 5910:2024, cardiac valve repair devices, heart valve repair systems, verification and validation, risk management, preclinical in vivo, clinical investigation, device durability, material properties, packaging, labelling.