EN ISO 5840-2:2021

• Abstract:

  This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.; This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.; This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.; This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.; For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.

• Status: Published
• Publication Date: 02-Feb-2021
• Withdrawal Date: 30-Aug-2021
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Feb-2021
• Completion Date: 03-Feb-2021
• Ref Project: SIST EN ISO 5840-2:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021)

• Replaces: EN ISO 5840-2:2015 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
• Effective Date: 09-Feb-2021
• Refers: ISO 14630:2012 - Non-active surgical implants — General requirements
• Effective Date: 25-Aug-2026
• Refers: ISO 10993-2:2006 - Biological evaluation of medical devices — Part 2: Animal welfare requirements
• Effective Date: 25-Aug-2026
• Refers: ISO 16061:2015 - Instrumentation for use in association with non-active surgical implants — General requirements
• Effective Date: 25-Aug-2026
• Refers: ISO 5840-3:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques
• Effective Date: 25-Aug-2026
• Refers: ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice
• Effective Date: 25-Aug-2026
• Refers: ISO 5840-1:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
• Effective Date: 25-Aug-2026
• Refers: EN ISO 11855-8:2023 - Building environment design - Design, dimensioning, installation and control of embedded radiant heating and cooling systems - Part 8: Electrical heating systems (ISO 11855-8:2023)
• Effective Date: 28-Jan-2026
• Refers: EN ISO 10961:2012 - Gas cylinders - Cylinder bundles - Design, manufacture, testing and inspection (ISO 10961:2010)
• Effective Date: 28-Jan-2026
• Refers: CEN/TS 17778:2022 - Organic and organo-mineral fertilizers - Determination of the chromium(VI) content by chromotography
• Effective Date: 28-Jan-2026
• Refers: EN 84:2020 - Durability of wood and wood-based products - Accelerated ageing of treated wood prior to biological testing - Leaching procedure
• Effective Date: 28-Jan-2026
• Refers: EN 17394-2:2020 - Textiles and textile products - Part 2: Safety of children's clothing - Security of attachment of buttons - Test method
• Effective Date: 28-Jan-2026
• Referred By: EN 12006-2:1998+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 28-Jan-2026
• Referred By: EN ISO 80601-2-13:2022 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2022)
• Effective Date: 28-Jan-2026
• Consolidated By: ISO 5840-2:2021 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
• Effective Date: 12-Feb-2026

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.