ISO 5840-1:2015
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements
ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.
ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1:2015 outlines an approach for qualifying 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 may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1:2015 defines operational conditions for heart valve substitutes.
ISO 5840-1:2015 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
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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 Implant procedure
6.2.4 Packaging, labelling, and sterilization
6.3 Design outputs
6.4 Design transfer (manufacturing verification/validation)
6.5 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
7.2 In vitro assessment
7.3 Preclinical in vivo evaluation
7.4 Clinical investigations
Annex A (informative) Rationale for the provisions of this part of ISO 5480
Annex B (normative) Packaging
Annex C (normative) Product labels, instructions for use, and training
Annex D (normative) Sterilization
Annex E (informative) In vitro test guidelines for paediatric devices
Annex F (informative) Statistical procedures when using in vitro performance criteria
Annex G (informative) Examples and definitions of some physical and material properties of heart valve systems
Annex H (informative) Examples of standards applicable to testing of materials and components of heart valve systems
Annex I (informative) Raw and post-conditioning mechanical properties for support structure materials
Annex J (informative) Corrosion assessment
Annex K (informative) Echocardiographic protocol
Bibliography
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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 Implant procedure
6.2.4 Packaging, labelling, and sterilization
6.3 Design outputs
6.4 Design transfer (manufacturing verification/validation)
6.5 Risk management
7 Design verification testing and analysis/design validation
7.1 General requirements
7.2 In vitro assessment
7.3 Preclinical in vivo evaluation
7.4 Clinical investigations
Annex A (informative) Rationale for the provisions of this part of ISO 5480
Annex B (normative) Packaging
Annex C (normative) Product labels, instructions for use, and training
Annex D (normative) Sterilization
Annex E (informative) In vitro test guidelines for paediatric devices
Annex F (informative) Statistical procedures when using in vitro performance criteria
Annex G (informative) Examples and definitions of some physical and material properties of heart valve systems
Annex H (informative) Examples of standards applicable to testing of materials and components of heart valve systems
Annex I (informative) Raw and post-conditioning mechanical properties for support structure materials
Annex J (informative) Corrosion assessment
Annex K (informative) Echocardiographic protocol
Bibliography