ANSI AAMI ISO 5840-1:2015 pdf download – Cardiovascular implants – Cardiac valve prostheses
1 Scope
This part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840–series provide specific requirements. This part of ISO 5840 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This part of ISO 5840 outlines an approach for qualifying 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 may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This part of ISO 5840 defines operational conditions for heart valve substitutes. This part of ISO 5840 excludes homografts. NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
The rationale for basing this part of ISO 5840 on risk management is that the traditional requirements-based model cannot keep up with the speed of technological innovation. With the requirements-based model, manufacturers have to spend their time looking for ways to comply with the requirements of the standard rather than on developing new technologies that could lead to inherently safer products. The risk-based model challenges the manufacturer to continually evaluate known and theoretical risks of the device to develop the most appropriate methods for reducing the risks of the device and to implement the appropriate test and analysis methods to demonstrate that the risks have been reduced. This part of ISO 5840 combines a requirement for implementing the risk-based model with best practice methods for verification testing appropriate to heart valve system evaluation. The intent of the risk assessment is to identify the hazards along with the corresponding failure modes and causes in order to identify the requisite testing and analysis necessary to evaluate the risk associated with each specific hazard. The risk management process provides the opportunity for the manufacturer to evaluate the best practice methods included within this part of ISO 5840. The manufacturer may choose to follow the best practice method as defined within this part of ISO 5840 or may deviate from the method and provide a scientific justification for doing so. The risk management file required by ISO 1 4971 should document these decisions with rationale. The risk-based model requires a collaborative environment between the device developer (the manufacturer) and the body responsible for verifying compliance with the applicable regulation regarding safety and performance of the device. The manufacturer should strive for continuous improvement in device design, as well as test methodologies that can ensure safety and performance of a device with less reliance on years of patient experience for evidence of effectiveness.