ISO 5840-2:2021 PDF

Scope: This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components. This document is 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. This document establishes an approach for verifying/validating 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 can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute. This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. For some heart valve substitutes (e.g. sutureless), the requirements of both this document and based on the results of the risk analysis.

ISO 5840-2:2021 Referenced Document

ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14630 Non-active surgical implants - General requirements
ISO 16061 Instruments for use in association with non-active surgical implants - General requirements*， 2021-02-28 Update
ISO 5840-1:2021 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
ISO 5840-3 Cardiovascular implants*， 2024-01-01 Update

2021 ISO 5840-2:2021 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
2015 ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes