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BS EN ISO 5840-1:2021

BS EN ISO 5840-1:2021

$215.11

Cardiovascular implants. Cardiac valve prostheses – General requirements

Published By Publication Date Number of Pages
BSI 2021 88
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This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.

ISO 5840-1 outlines an approach for verifying/validating 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 can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ISO 5840-1 defines operational conditions for heart valve substitutes.

ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.

ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.

NOTE

A rationale for the provisions of ISO 5840-1 is given in Annex A.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
23 4 Abbreviations
5 Fundamental requirements
24 6 Device description
6.1 General
6.2 Intended use
6.3 Design inputs
6.3.1 Operational specifications
25 6.3.2 Performance specifications
6.3.3 Implant procedure
6.3.4 Packaging, labelling, and sterilization
26 6.4 Design outputs
6.5 Design transfer (manufacturing verification/validation)
6.6 Risk management
7 Design verification and validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 General
27 7.2.2 Test conditions, sample selection and reporting requirements
28 7.2.3 Material property assessment
29 7.2.4 Hydrodynamic performance assessment
7.2.5 Structural performance assessment
31 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
32 7.3 Preclinical in vivo evaluation
7.4 Clinical investigations
33 Annex A (informative) Rationale for the provisions of ISO 5840-1
36 Annex B (normative) Packaging
37 Annex C (normative) Product labels, instructions for use, and training
40 Annex D (normative) Sterilization
41 Annex E (normative) In vitro test guidelines for paediatric devices
45 Annex F (informative) Corrosion assessment
48 Annex G (informative) Echocardiographic protocol
50 Annex H (informative) Assessment of implant thrombogenic and haemolytic potential
61 Annex I (informative) Guidelines for hydrodynamic performance characterization by steady flow testing
68 Annex J (normative) Durability testing
76 Annex K (informative) Fatigue assessment
81 Annex L (normative) Clinical investigation endpoints for heart valve replacement devices
84 Bibliography

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BS EN ISO 5840-1:2021
$215.11