ISO 5840-3:2021

Overview

ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - is the international standard that defines engineering, testing and evaluation expectations for transcatheter heart valve substitutes and their associated devices, packaging and labelling. It applies to devices intended for implantation by transcatheter routes (e.g., TAVI/TMVI) and to accessory devices and methods used to select appropriate valve size. The standard frames a risk‑based approach to design verification and validation and establishes performance and operational requirements where clinical or scientific evidence supports them.

Key topics and technical requirements

• Scope and intended use: Requirements for device description, intended clinical application and implant procedures (including valve‑in‑valve and valve‑in‑ring scenarios).
• Risk management: Integration of ISO-compliant risk assessment to guide selection of verification/validation tests.
• Design inputs/outputs and manufacturing transfer: Documentation of operational and performance specifications, design outputs, and manufacturing verification/validation.
• In vitro testing: Material property assessments, hydrodynamic (pulsatile flow) performance, structural and fatigue/durability testing, corrosion and thrombogenicity evaluation, visibility and MRI compatibility.
• Delivery system evaluation: Requirements for delivery device design, simulated use, and human factors/usability assessments.
• Preclinical in vivo evaluation: Animal study considerations, methods and reporting requirements when required by risk assessment.
• Clinical investigations: Study design, endpoints, statistical considerations, duration and safety reporting for first‑in‑human and pivotal clinical evaluations.
• Packaging, labelling and sterilization: Normative annexes give expectations for packaging, product labels, instructions for use and sterilization validation.
• Annexes and guidance: Informative annexes provide rationale, examples, imaging protocols, test guidelines, and references to applicable test standards.

Practical applications and who uses it

ISO 5840-3:2021 is essential for:

• Medical device manufacturers of transcatheter heart valves and delivery systems (design, testing and regulatory submissions).
• Regulatory affairs and quality teams preparing conformity documentation and clinical evidence packages.
• Test laboratories and contract research organizations performing hydrodynamic, durability, biocompatibility and preclinical testing.
• Clinicians and clinical investigators designing and conducting clinical trials for new transcatheter valves.
• Notified bodies and regulatory agencies assessing safety and performance claims.

Related standards

• Part of the ISO 5840 series (general requirements for cardiac valve prostheses). Manufacturers typically use ISO 5840-3 together with the other parts of the series and relevant material and biocompatibility standards when preparing design dossiers and regulatory submissions.

Keywords: ISO 5840-3:2021, transcatheter heart valve, TAVI, TMVI, cardiac valve prostheses, valve-in-valve, hydrodynamic testing, durability testing, risk management, clinical evaluation.