What is ISO 5840‑3 about?
ISO 5840 discusses standards for the issues associated with heart valve substitutes and their development. ISO 5840‑3 is the third part of a series of documents which focuses on cardiovascular implants and cardiac valve prostheses. ISO 5840‑3 defines operational conditions and performance of Heart valve substitutes implanted by transcatheter techniques.
ISO 5840‑3 is one of the series of documents for cardiovascular implants that is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
ISO 5840‑3 is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in Vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840‑3 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification and includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g., valve-in-valve and valve-in-ring configurations).
Who is ISO 5840‑3 for?
ISO 5840‑3 on heart valve substitutes implanted by transcatheter techniques is useful for:
- Manufactures of cardiac valve prostheses for Cardiovascular implants
- Testing laboratories of cardiovascular implants
- Cardiovascular implants developers and engineers
- Manufacturers of cardiac implant devices
- Industry involved in cardiovascular implants
- Cardiologist
Why should you use ISO 5840‑3?
Heart valve substitutes implanted by transcatheter techniques is minimally invasive heart procedure used to replace a thickened aortic valve that cannot fully open (aortic valve stenosis). The aortic valve is situated between the left lower heart chamber (left ventricle) and the main artery of the body (aorta). Blood flow from the heart to the body is reduced if the valve does not open properly.Transcatheter techniques help restore blood flow and alleviate the symptoms of aortic valve stenosis, such as chest pain, shortness of breath, fainting, and fatigue.
ISO 5840‑3 provides you with guidelines for verification of hemoynamic performance and durability characteristics of heart valve substitutes and systems required for their implantation with transcatheter techniques.
ISO 5840‑3 on transcatheter heart valve substitutes provides guidance to you 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.
ISO 5840‑3 intends to clarify the procedures prior to market release and to enable prompt identification and management of any subsequent issues.
ISO 5840‑3 establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management.
By using ISO 5840‑3 guidelines you can improve intended performance, design attributes, pre-clinical, clinical evaluation, safety, and efficacy of heart valve substitutes for end-users. It also helps you in improving the manufacturing process for cardiac valve prostheses by providing general requirements like accessory devices, packaging, and labelling and by providing test methods for assessment in terms of physical, chemical, biological, and mechanical properties which ensures high-quality standards are maintained.
What’s changed since the last update?
BS EN ISO 5840‑3:2021 supersedes ISO 5840‑3:2021, which has been withdrawn. BS EN ISO 5840‑3:2021 has some technical changes with respect to ISO 5840‑3:2021, these includes:
- The engineering and clinical requirements in the ISO 5840 series have been updated to current specifications and integrated and harmonized across all parts.