ISO 5840-2:2015
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes
ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
ISO 5840-2:2015 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.
ISO 5840-2:2015 outlines 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.
ISO 5840-2:2015 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.
ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
ISO 5840-2:2015 excludes homografts.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
6.1 Intended use
6.2 Design inputs
6.2.1 Operational specifications
6.2.2 Performance specifications
6.2.3 Packaging, labelling, and sterilization
6.3 Design outputs
6.3.1 General
6.4 Design transfer (manufacturing qualification)
6.5 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 Test conditions, sample selection, and reporting requirements
7.2.2 Material property assessment
7.2.3 Hydrodynamic performance assessment
7.2.4 Structural performance assessment
7.2.5 Device MRI safety
7.2.6 Additional implant design evaluation requirements
7.2.7 Design specific testing
7.2.8 Simulated use
7.2.9 Human factors/usability assessment
7.3 Preclinical in vivo evaluation
7.3.1 Overall requirements
7.3.2 Methods
7.3.3 Test report
7.4 Clinical investigation
7.4.1 General
7.4.2 Statistical considerations
7.4.3 Distribution of subjects and investigators
7.4.4 Sample size
7.4.5 Entry criteria
7.4.6 Duration of the study
7.4.7 Clinical data requirements
7.4.8 Clinical investigation report
Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods
Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers
Annex C (informative) Preclinical in vivo evaluation
Annex D (informative) Description of the surgical heart valve substitute
Annex E (informative) Examples of components of some surgical heart valve substitutes
Annex F (informative) Guidelines for verification of hydrodynamic performance
Annex G (informative) Durability testing
Annex H (informative) Examples of design specific testing
Annex I (informative) Fatigue assessment
Annex J (normative) Methods of evaluating clinical data
Bibliography
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
-
BS 2574-1:1991
Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses
-
BS 2574-2:1994
Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses
-
BS 3531-11:1991
Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Fundamental requirements
6 Device description
6.1 Intended use
6.2 Design inputs
6.2.1 Operational specifications
6.2.2 Performance specifications
6.2.3 Packaging, labelling, and sterilization
6.3 Design outputs
6.3.1 General
6.4 Design transfer (manufacturing qualification)
6.5 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
7.2 In vitro assessment
7.2.1 Test conditions, sample selection, and reporting requirements
7.2.2 Material property assessment
7.2.3 Hydrodynamic performance assessment
7.2.4 Structural performance assessment
7.2.5 Device MRI safety
7.2.6 Additional implant design evaluation requirements
7.2.7 Design specific testing
7.2.8 Simulated use
7.2.9 Human factors/usability assessment
7.3 Preclinical in vivo evaluation
7.3.1 Overall requirements
7.3.2 Methods
7.3.3 Test report
7.4 Clinical investigation
7.4.1 General
7.4.2 Statistical considerations
7.4.3 Distribution of subjects and investigators
7.4.4 Sample size
7.4.5 Entry criteria
7.4.6 Duration of the study
7.4.7 Clinical data requirements
7.4.8 Clinical investigation report
Annex A (informative) Heart valve substitute hazards, associated failure modes, and evaluation methods
Annex B (informative) In vitro procedures for testing unstented or similar valves in compliant chambers
Annex C (informative) Preclinical in vivo evaluation
Annex D (informative) Description of the surgical heart valve substitute
Annex E (informative) Examples of components of some surgical heart valve substitutes
Annex F (informative) Guidelines for verification of hydrodynamic performance
Annex G (informative) Durability testing
Annex H (informative) Examples of design specific testing
Annex I (informative) Fatigue assessment
Annex J (normative) Methods of evaluating clinical data
Bibliography