What is ISO 5840‑2 about?
ISO 5840 discusses standards for the issues associated with heart valve substitutes and their development. ISO 5840‑2 is the second part of a series of documents, focuses on cardiovascular implants and cardiac valve prostheses. ISO 5840‑2 defines operational conditions and performance requirements for surgical heart valve substitutes and is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. ISO 5840‑2 is also 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.
ISO 5840‑2 defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
ISO 5840‑2 is used in conjunction with ISO 5840‑1 and ISO 5840‑3. For some heart valve substitutes (e.g., sutureless), the requirements of both ISO 5840‑2 and ISO 5840-3 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.
Who is ISO 5840‑2 for?
ISO 5840‑2 on Surgically implanted heart valve substitutes is useful for:
- Manufacturers of Cardiac valve prostheses for surgical implants
- Cardiac valve prostheses developers and engineers
- Testing laboratories for cardiovascular implants
- Manufacturers of cardiac implant devices
- Industries involved in cardiovascular implants
- Cardiologist
Why should you use ISO 5840‑2?
Cardiovascular implants have been widely used to treat all sorts of cardiovascular problems. High quality and biocompatible cardiac valve with good hemodynamics prevent infection, damage to the blood vessel. ISO 5840‑2 provides you with guidelines for hydrodynamic performance and durability characteristics of heart valve substitutes and systems required for their implantation.
ISO 5840‑2 on surgical heart valve substitutes emphasises on providing guidance for in vitro testing, preclinical in vivo and clinical evaluations, reporting of all in vitro, preclinical in vivo, and clinical evaluations, and labelling and packaging of the device. This process is intended to clarify the required procedures prior to market release and to enable prompt identification and management of any subsequent issues. By using ISO 5840‑1 guidelines you can improve intended performance, design attributes, pre-clinical, clinical evaluation, safety, and efficacy of cardiac valve for end-users.
ISO 5840‑2 design guidelines help you to verify/validate 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 which ensures results are reliable and can be reproduced in any other laboratory.
ISO 5840‑2 is intended to demonstrate the linkage among potential hazards, foreseeable sequence of events, hazardous situations, and harms for surgical heart valve substitutes.
What’s changed since the last update?
BS EN ISO 5840‑2:2021 supersedes ISO 5840‑2:2015, which has been withdrawn. BS EN ISO 5840‑2:2021 has some technical changes with respect to ISO 5840‑2:2015, these include:
- The engineering and clinical requirements in the ISO 5840 series have been updated to current specifications and integrated and harmonized across all its parts.