ANSI/AAMI/ISO 5840-2:2015 pdf download.Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This part of ISO 5840 outines an approach for qualifying 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. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This part of ISO 5840 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840-3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.
This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
This part of Iso 5840 excludes homografts.
2 Normative references
The fllowing documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISo 5840-1:2015, Cardiovascular implants and extracoporeal systems - Cardiac valve prostheses- Part 1: General requirements
ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2, Biological evaluation of medical devices一Part 2: Animal welfare requirements
ISO 14155, Clinical investigation of medical devices for human subjects一Good clinical practice
ISo 14630, Non-active surgical implants - - General requirements
ISo 14971, Medical devices - . Application of risk management to medical devices.ANSI/AAMI/ISO 5840-2 pdf download.