SIST EN ISO 5840-2:2021 PDF

Overview

EN ISO 5840-2:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - is the harmonized CEN/ISO standard for surgical heart valve substitutes intended for implantation in human hearts (typically requiring cardiopulmonary bypass and direct visualization). It applies to newly developed and modified surgical valve prostheses and to accessory devices, packaging, sterilization, and labelling needed for implantation and sizing. The standard replaces EN ISO 5840-2:2015 and aligns design, verification, and validation through risk management across the ISO 5840 series.

Key topics and requirements

• Scope and device description: Defines intended use, design inputs/outputs, packaging, labelling and sterilization requirements for surgically implanted heart valve substitutes.
• Risk management-driven approach: Requires hazard analysis to guide selection of qualification tests and validation methods.
• Design verification and validation:
  • In vitro testing: Hydrodynamic performance (pulsatile flow), material property assessment, structural testing, simulated use, MRI compatibility, thrombogenic and haemolytic potential, and device-specific testing.
  • Preclinical in vivo evaluation: Requirements and reporting expectations for animal studies supporting safety and performance.
  • Clinical investigations: Study design, endpoints, statistical considerations, ethical issues and clinical data requirements for demonstrating clinical performance.
• Operational and performance requirements: Defines performance expectations where scientific/clinical evidence exists (e.g., fatigue assessment, durability).
• Human factors and usability: Simulated use and usability assessments to reduce user-related risks.
• Annexes: Informative and normative annexes provide examples, testing guidance (pulsatile flow, fatigue), hazard analysis templates, and objective performance criteria.

Practical applications

• Guides manufacturers and designers in the development and modification of surgically implanted heart valve substitutes and related accessories.
• Supports regulatory submissions by specifying the types of in vitro, preclinical, and clinical evidence expected for safety and performance claims.
• Informs testing laboratories and contract research organizations (CROs) about required test methods (hydrodynamic, structural, biological) and reporting.
• Helps hospitals and clinical investigators understand clinical data endpoints and study design expectations for device evaluation.

Who should use this standard

• Medical device manufacturers (R&D, design verification/validation teams)
• Regulatory affairs professionals preparing conformity documentation
• Quality and risk management engineers
• Test laboratories, CROs, and preclinical/clinical investigators
• Notified bodies and auditors assessing compliance with cardiac valve prosthesis standards

Related standards

• ISO 5840 series (Part 1, Part 3, etc.) - EN ISO 5840-2:2021 should be used in conjunction with other parts of the ISO 5840 series. In particular, ISO 5840-3:2021 may apply for certain device types (e.g., sutureless valves) where both documents are relevant.

Keywords: EN ISO 5840-2:2021, surgically implanted heart valve substitutes, cardiac valve prostheses, heart valve standard, valve prosthesis testing, cardiovascular implants.