ISO 5840 discusses standards for the issues associated with heart valve substitutes and their development. ISO 5840‑1 is first part in a series of documents focusses on cardiovascular implants and cardiac valve prostheses. ISO 5840‑1 is applicable to heart valve substitutes intended for implantation and provides general requirements.
ISO 5840‑1 is also applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840‑1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are 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 5840‑1 is used in conjunction with ISO 5840‑2 and ISO 5840‑3.
Note: ISO 5840-1 does not provide requirements specific to homograft, tissue-engineered heart valves (e.g., valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made for human tissue that is rendered non-viable.
ISO 5840‑1 on cardiovascular implants is useful for:
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 5840‑1 provides you with guidelines for hydrodynamic performance and durability characteristics of heart valve substitutes and systems required for their implantation with in-vitro testing, steady flow testing, durability testing.
Obtaining ISO 5840‑1 helps you with types of tests, provides guidance for test methods and test apparatuses, and requirement of documentation of test methods and results for cardiac valve prostheses.
ISO 5840‑1 helps you ensure that associated risks to the patient and other users of the device have been adequately mitigated. ISO 5840‑1 facilitates quality assurance, aids the clinician in choosing a heart valve substitute, and ensures that the device is presented in a convenient form.
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.
BS EN ISO 5840‑1:2021 supersedes ISO 5840‑1:2015, which has been withdrawn. BS EN ISO 5840‑1:2021 has some technical changes with respect to ISO 5840‑1:2015, these include:
ISO 5840-1
EN ISO 5840-1