ISO 5840-1-2021 amd1-2025 PDF

Full title and description

ISO 5840-1:2021/Amd 1:2025 — Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1. This amendment updates and/or clarifies provisions of ISO 5840-1:2021 and is published as an amendment to the 2021 edition of the standard.

Abstract

ISO 5840-1 sets out general requirements for heart valve substitutes intended for implantation, including an approach to design verification and validation through risk management and selection of appropriate qualification tests (physical, chemical, biological and mechanical), preclinical in vivo evaluation and clinical evaluation. Amendment 1 (2025) provides targeted updates and corrections to the 2021 text (publishing clarifications, editorial/technical corrections and limited additions where needed) so that manufacturers and regulators can apply the general requirements consistently.

General information

• Status: Published.
• Publication date: 4 March 2025.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics).
• Edition / version: Edition 2 (ISO 5840-1:2021) — Amendment 1 (2025).
• Number of pages: 5 pages (amendment document).

Scope

This amendment applies to ISO 5840-1:2021, which is applicable to heart valve substitutes intended for implantation and to associated accessory devices, packaging and labelling used to determine appropriate sizing and safe use. The main standard defines operational conditions, terminology shared across the ISO 5840 series, and a risk‑based approach to selecting verification and validation tests; the amendment introduces specific clarifications and corrections to the 2021 text.

Key topics and requirements

• Clarifications to definitions and terms used across the ISO 5840 series (Part 1 provides common terminology).
• Reinforcement of a risk-management approach to design verification and validation in accordance with the 5840 framework.
• Guidance on selection of qualification and performance tests (physical, chemical, biological and mechanical), and on when preclinical in vivo and clinical evaluations are required.
• Updates or editorial/technical corrections to requirements for labelling, packaging and device accessory considerations.
• Alignment and cross‑references with other parts of the ISO 5840 series (to ensure consistent application across surgically implanted and transcatheter devices).

Typical use and users

Primary users are medical device manufacturers of heart valve prostheses, test laboratories, regulatory and conformity assessment bodies, notified bodies, clinical researchers and design engineers involved in valve development and post‑market evidence generation. The amendment is used to ensure that device design verification/validation and clinical evaluation programs remain aligned with the latest ISO guidance.

Related standards

ISO 5840 is a multi‑part series. Key related documents include ISO 5840-2 (surgically implanted heart valve substitutes) and ISO 5840-3 (transcatheter heart valve substitutes); these parts have been maintained and received corresponding amendments in 2025 as part of the series maintenance. Other commonly referenced standards when applying ISO 5840-1 include ISO 10993 series (biocompatibility), ISO 14971 (medical device risk management) and ISO 13485 (medical device quality systems).

Keywords

cardiac valve prosthesis; cardiovascular implants; heart valve substitute; risk management; verification and validation; biocompatibility; clinical evaluation; labelling; packaging; ISO 5840; amendment 2025.

FAQ

Q: What is this standard?

A: ISO 5840-1:2021/Amd 1:2025 is Amendment 1 (2025) to Part 1 of the ISO 5840 series, titled "Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements". It modifies/clarifies parts of the 2021 edition of ISO 5840-1.

Q: What does it cover?

A: It covers general requirements applicable to heart valve substitutes intended for implantation, including terminology, operational conditions, a risk‑based approach to selecting tests and methods (physical/chemical/biological/mechanical), and requirements for preclinical and clinical evaluation where applicable. The amendment provides focused updates and corrections to the 2021 text.

Q: Who typically uses it?

A: Device manufacturers, design and verification engineers, test laboratories, regulatory affairs specialists, notified bodies and clinical researchers involved with heart valve substitutes use this standard to guide design controls, testing, clinical evaluation and labeling/packaging practices.

Q: Is it current or superseded?

A: The amendment is published and current as of 4 March 2025; it amends and supplements the ISO 5840-1:2021 edition rather than superseding the base document. Users should apply the 2021 edition together with Amendment 1 (2025).

Q: Is it part of a series?

A: Yes — ISO 5840 is a multi‑part series. Part 1 contains general requirements; Part 2 covers surgically implanted heart valve substitutes and Part 3 covers transcatheter heart valve substitutes. Corresponding amendments for related parts were also published in the 2025 update cycle.

Q: What are the key keywords?

A: Cardiac valve prosthesis, cardiac valve, heart valve substitute, cardiovascular implant, risk management, verification, validation, biocompatibility, clinical evaluation, labelling, packaging, ISO 5840-1.