SIST EN ISO 5840-3:2021 PDF

Overview - EN ISO 5840-3:2021 (Cardiac valve prostheses, Part 3)

EN ISO 5840-3:2021 is the CEN-adopted edition of ISO 5840-3:2021 that addresses heart valve substitutes implanted by transcatheter techniques (e.g., TAVI/TAVR, TMVI). The standard applies to all transcatheter heart valve substitutes and related accessory devices, packaging and labelling used to size and implant these devices. It establishes a risk-based framework for design verification and validation, and defines operational conditions and performance requirements where sufficient scientific or clinical evidence exists. EN ISO 5840-3:2021 supersedes the 2013 edition and is part of the ISO 5840 series for cardiac valve prostheses.

Key topics and technical requirements

• Scope and device description: Intended use, design inputs/outputs, implant procedures, packaging, sterilization and labelling requirements.
• Risk management: Use risk assessment to select appropriate verification and validation tests and methods.
• Verification and validation testing: Guidance for in vitro assessments covering material properties, hydrodynamic performance, structural testing, thrombogenicity/haemolysis potential, simulated use and MRI compatibility.
• Preclinical in vivo evaluation: Principles, methods, reporting and considerations for animal studies.
• Clinical evaluation: Study design, endpoints, patient selection, safety reporting and statistical considerations for clinical investigations and pivotal trials.
• Delivery system requirements: Design and evaluation of delivery systems (normative annex).
• Annex guidance: Includes hydrodynamic test guidelines, examples of design-specific testing, preclinical evaluation examples, adverse event classification, and multimodality imaging considerations.

Keywords naturally integrated: transcatheter heart valve, cardiac valve prostheses, verification and validation, hydrodynamic performance, risk management.

Practical applications - who uses this standard

• Manufacturers and device designers - to define design inputs/outputs, select verification/validation tests, and document manufacturing transfer.
• Regulatory and quality teams - to support conformity assessment, technical files and regulatory submissions for transcatheter heart valves.
• Test laboratories and preclinical researchers - for protocols on in vitro testing, simulated use and preclinical in vivo studies.
• Clinical investigators and hospitals - to design clinical investigations, select endpoints, and implement safety reporting.
• Notified bodies and auditors - to assess compliance with recognized engineering and clinical performance requirements.

Related standards

• Part of the ISO 5840 series (cardiac valve prostheses). Relevant cross-references include other ISO 5840 parts and normative references listed in EN ISO 5840-3:2021 for materials, biocompatibility and sterilization standards.

For device makers and regulators working with TAVI/TMVI and valve‑in‑valve configurations, EN ISO 5840-3:2021 provides the risk‑based, evidence‑driven framework to plan testing, preclinical work and clinical evaluation.