ISO 5840-2-2021 amd1-2025 PDF

Full title and description

ISO 5840-2:2021/Amd 1:2025 — Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1. This amendment updates and supplements ISO 5840-2:2021 with limited changes and clarifications to requirements, tests and normative text for surgically implanted heart valve substitutes.

Abstract

This amendment applies to ISO 5840-2:2021 and provides targeted revisions to the requirements and normative provisions for surgically implanted heart valve substitutes. ISO 5840-2 establishes an approach for design verification and validation through risk management, and describes selection of qualification tests (physical, chemical, biological, mechanical), pre‑clinical in vivo evaluation and clinical evaluation where appropriate; the amendment refines or adds to those provisions as specified.

General information

• Status: Published.
• Publication date: 4 March 2025 (Edition 2, Amendment 1, published March 2025).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics / Cardiovascular implants).
• Edition / version: Edition 2 (ISO 5840-2:2021) with Amendment 1 (2025).
• Number of pages: 2 pages (text of the amendment).

Scope

The amendment modifies ISO 5840-2:2021, which is applicable to surgically implanted heart valve substitutes intended for implantation in human hearts (generally requiring cardiopulmonary bypass and direct visualization). The standard (as amended) covers newly developed and modified surgical heart valve substitutes and associated accessories, packaging and labelling relevant to implantation and sizing; it sets out verification/validation approaches derived from risk assessment and defines operational conditions and performance requirements where evidence exists.

Key topics and requirements

• Clarifications and changes to normative requirements for surgically implanted heart valve substitutes introduced as Amendment 1 to ISO 5840-2:2021.
• Risk‑management based approach to selection of qualification tests and test methods (physical, chemical, biological, mechanical).
• Requirements and guidance for pre‑clinical (in vitro and in vivo) evaluation and clinical evaluation where applicable.
• Performance and operational condition specifications for surgically implanted valves where supported by scientific/clinical evidence.
• Interaction and applicability notes with other parts of the ISO 5840 series (for example where sutureless designs may also invoke requirements of ISO 5840-3).

Typical use and users

Primary users are medical device manufacturers (design and regulatory teams), test laboratories, notified bodies/ conformity assessment authorities, clinical investigators and regulatory reviewers who develop, test, certify or evaluate surgically implanted heart valve substitutes. Surgeons and clinical research teams may consult the standard for performance expectations, labelling and clinical evaluation guidance.

Related standards

ISO 5840-2 is part of the ISO 5840 family on cardiac valve prostheses (parts include general requirements and other device‑specific parts such as transcatheter heart valves). Related documents often referenced with ISO 5840-2 include ISO 5840-1 (General requirements), ISO 5840-3 (transcatheter heart valve substitutes), relevant biocompatibility standards (ISO 10993 series) and other medical device testing and labelling standards. Regional/adopted versions (for example EN ISO adoptions) implement the amendment as national/regional standards.

Keywords

cardiovascular implants; cardiac valve prostheses; surgically implanted heart valve substitutes; ISO 5840-2; amendment 2025; risk management; pre-clinical testing; clinical evaluation; biocompatibility.

FAQ

Q: What is this standard?

A: ISO 5840-2:2021/Amd 1:2025 is Amendment 1 (2025) to ISO 5840-2:2021, the ISO international standard that specifies requirements for surgically implanted heart valve substitutes (surgical heart valves).

Q: What does it cover?

A: It covers updates to the normative text of ISO 5840-2:2021, refining requirements and test/validation expectations for surgically implanted heart valve substitutes, including provisions for selection of qualification tests derived from risk assessment and guidance on pre‑clinical and clinical evaluation.

Q: Who typically uses it?

A: Medical device manufacturers (design, testing and regulatory affairs), conformity assessment bodies, test laboratories, regulatory agencies and clinicians involved in device evaluation and post‑market surveillance.

Q: Is it current or superseded?

A: The amendment was published in March 2025 and is an active update to ISO 5840-2:2021; it is not a full revision of the base standard but a published amendment that modifies the 2021 edition. Users should apply the 2021 text together with this 2025 amendment.

Q: Is it part of a series?

A: Yes — ISO 5840 is a family of standards covering cardiac valve prostheses (including Part 1: general requirements, Part 2: surgically implanted substitutes, and Part 3: transcatheter implants). The amendment applies specifically to Part 2.

Q: What are the key keywords?

A: cardiovascular implants; cardiac valve prostheses; surgical heart valves; amendment; validation; risk management; pre-clinical testing; clinical evaluation.