EN ISO 5840-1:2021 PDF

Overview

EN ISO 5840-1:2021 - Cardiovascular implants: Cardiac valve prostheses (Part 1: General requirements) sets out the general requirements for heart valve substitutes intended for implantation. It applies to newly developed and modified valve prostheses as well as accessory devices, packaging and labelling, sizing guidance, and the verification/validation approach used during design and manufacture. The standard emphasizes a risk‑based selection of qualification tests (physical, chemical, biological and mechanical), and covers in vitro, preclinical in vivo and clinical evaluation pathways. It also defines operational conditions, common terms, and reporting expectations for the ISO 5840 series.

Key topics and requirements

• Scope and applicability: Heart valve substitutes for implantation (excludes specific requirements for homografts, tissue‑engineered regenerative valves and valves for circulatory support devices; some provisions may apply to non‑viable human tissue).
• Risk management approach: Verification and validation activities are driven by risk assessment; test selection and methods derive from identified risks.
• Design controls: Requirements for design inputs/outputs, operational and performance specifications, implant procedure description, packaging, labelling and sterilization considerations.
• Verification & validation:
  • In vitro assessments (material property, hydrodynamic performance, structural performance, simulated use, MRI compatibility, haemolytic and thrombogenic potential).
  • Preclinical in vivo evaluation.
  • Clinical investigations and defined clinical endpoints.
• Test guidance and annexes: Normative and informative annexes provide rationale, packaging (B), labelling and training (C), sterilization (D), pediatric test guidance (E), corrosion, echocardiography, thrombogenic assessment, hydrodynamic and durability testing (J), fatigue assessment, and clinical endpoints (L).
• Reporting & documentation: Clear requirements for reporting test methods, results and rationale to support safety, performance and regulatory review.

Practical applications & users

EN ISO 5840-1:2021 is used by:

• Medical device manufacturers (design engineers, R&D, quality and regulatory teams) to define development and verification strategies for new or modified valve prostheses.
• Test laboratories and preclinical researchers to select appropriate in vitro and in vivo evaluations derived from the device risk assessment.
• Clinical investigators and hospitals preparing clinical evaluation plans or interpreting device performance criteria.
• Notified bodies and regulators reviewing conformity evidence and clinical endpoints as part of product assessment. Practical benefits include a harmonized, risk‑based framework for demonstrating safety, durability, hydrodynamic performance and biocompatibility of cardiac valve prostheses.

Related standards

• ISO 5840 series: ISO 5840-2 and ISO 5840-3 (device‑specific requirements) - EN ISO 5840-1 provides the general foundation used together with these parts.