ISO 5840-2:2021

Overview

ISO 5840-2:2021 - "Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes" is an international standard that sets requirements and guidance for the design verification, testing, preclinical and clinical evaluation, packaging, and labelling of surgically implanted heart valve substitutes. It applies to devices implanted during open surgery (generally requiring cardiopulmonary bypass and direct visualization), including newly developed and modified surgical valve substitutes and their accessory devices.

This part of the ISO 5840 series establishes a risk‑based approach to verify and validate device design and manufacture, and defines operational conditions and performance requirements where scientific or clinical evidence exists.

Key topics and requirements

• Scope and intended use: Applicability to surgical heart valve substitutes, associated accessories, packaging and sizing methods.
• Risk management: Device qualification and selection of appropriate tests based on risk assessment.
• Design inputs/outputs and transfer: Requirements for specifying operational and performance specifications and for manufacturing qualification.
• Design verification and validation: Emphasis on in vitro testing, preclinical in vivo evaluation, and clinical investigations tied to the risk profile.
• In vitro assessments (examples described):
  • Material property assessment
  • Hydrodynamic performance (pulsatile flow testing guidance in Annex F)
  • Structural performance and fatigue/durability testing (Annex G and I)
  • MRI safety and device compatibility
  • Thrombogenic and haemolytic potential, simulated use, and human factors/usability
• Preclinical and clinical evaluation: Guidance on study design, statistical considerations, endpoints, reporting, and adverse event classification (Annexes C and J).
• Documentation and labelling: Requirements for packaging, sterilization, labelling and clinical reporting.

Applications and who uses this standard

ISO 5840-2:2021 is used by:

• Medical device manufacturers designing and modifying surgically implanted heart valves and delivery/accessory systems.
• Regulatory and quality affairs teams preparing technical files, regulatory submissions, and conformity assessments.
• Test laboratories and contract research organizations (CROs) conducting in vitro, durability, and preclinical testing.
• Clinical investigators and cardiac device clinicians planning clinical investigations and interpreting device performance criteria.
• Design engineers and risk managers applying risk-based test selection and design verification.

Related standards

• ISO 5840-1 - General requirements for cardiac valve prostheses.
• ISO 5840-3:2021 - Requirements for transcatheter heart valve substitutes (may be relevant for some designs, e.g., sutureless valves).

Keywords: ISO 5840-2:2021, surgically implanted heart valve substitutes, cardiac valve prostheses, cardiovascular implants, hydrodynamic performance, durability testing, preclinical evaluation, clinical investigation, risk management.