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ČSN EN ISO 5840-2 (852927)
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Translate name
STANDARD published on 1.5.2022
The information about the standard:
Designation standards: ČSN EN ISO 5840-2
Classification mark: 852927
Catalog number: 514492
Publication date standards: 1.5.2022
SKU: NS-1055517
The number of pages: 64
Approximate weight : 192 g (0.42 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 5840-2 (852927):
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 ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis
Preview of the standard ČSN EN ISO 5840-2 (852927)
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