🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 5840-2:2021

BS EN ISO 5840-2:2021

$198.66

Cardiovascular implants. Cardiac valve prostheses – Surgically implanted heart valve substitutes

Published By Publication Date Number of Pages
BSI 2021 60
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Abbreviations
12 5 Fundamental requirements
6 Device description
6.1 General
6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications
6.3.2 Performance specifications
13 6.3.3 Packaging, labelling, and sterilization
6.4 Design outputs
6.5 Design transfer (manufacturing verification/validation)
14 6.6 Risk management
7 Design verification and validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
7.2.2 Test conditions, sample selection, and reporting requirements
7.2.3 Material property assessment
7.2.4 Hydrodynamic performance assessment
15 7.2.5 Structural performance assessment
16 7.2.6 Design- or procedure-specific testing
7.2.7 Device MRI compatibility
7.2.8 Simulated use
7.2.9 Human factors/usability assessment
7.2.10 Implant thrombogenic and haemolytic potential assessment
7.3 Preclinical in vivo evaluation
7.3.1 General
7.3.2 Overall requirements
17 7.3.3 Methods
18 7.3.4 Test report
19 7.4 Clinical investigations
7.4.1 General
20 7.4.2 Study considerations
21 7.4.3 Study endpoints
22 7.4.4 Ethical considerations
7.4.5 Pivotal studies: Distribution of subjects and investigators
23 7.4.6 Statistical considerations including sample size and duration
24 7.4.7 Patient selection criteria
25 7.4.8 Valve thrombosis prevention
7.4.9 Clinical data requirements
30 Annex A (informative) Surgical heart valve substitute hazard analysis example
32 Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers
34 Annex C (informative) Preclinical in vivo evaluation
37 Annex D (informative) Description of the surgical heart valve substitute and system
39 Annex E (informative) Examples of components of some surgical heart valve substitutes and systems
45 Annex F (informative) Guidelines for verification of hydrodynamic performance — Pulsatile flow testing
49 Annex G (informative) Examples of design specific testing
51 Annex H (informative) Fatigue assessment
53 Annex I (normative) Methods of evaluating clinical data against objective performance criteria
54 Annex J (normative) Adverse event classification during clinical investigation
59 Bibliography

Related products

BS EN ISO 5840-2:2021
$198.66