ISO 5840-2:2021-01

Herz- und Gefäßimplantate - Herzklappenprothesen - Teil 2: Chirurgisch implantierter Herzklappenersatz

Englischer Titel: Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
Ausgabedatum: 2021-01
Originalsprachen: Englisch
Seiten: 51

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Ausgabedatum: 2021-01
Originalsprachen: Englisch
Seiten: 51

Produktinformationen auf dieser Seite:

Inhaltsverzeichnis
ICS
Ersatzvermerk
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Inhaltsverzeichnis

Inhalt (en)

Foreword
Introduction
Scope
Normative references
Terms and definitions
Abbreviations
Fundamental requirements
Device description
- General
- Intended use
- Design inputs
  - Operational specifications
  - Performance specifications
  - Packaging, labelling, and sterilization
- Design outputs
- Design transfer (manufacturing verification/validation)
- Risk management
Design verification and validation
- General requirements
- In vitro assessment
  - General
  - Test conditions, sample selection, and reporting requirements
  - Material property assessment
  - Hydrodynamic performance assessment
  - Structural performance assessment
  - Design- or procedure-specific testing
  - Device MRI compatibility
  - Simulated use
  - Human factors/usability assessment
  - Implant thrombogenic and haemolytic potential assessment
- Preclinical in vivo evaluation
  - General
  - Overall requirements
  - Methods
  - Test report
- Clinical investigations
  - General
  - Study considerations
  - Study endpoints
  - Ethical considerations
  - Pivotal studies: Distribution of subjects and investigators
  - Statistical considerations including sample size and duration
  - Patient selection criteria
  - Valve thrombosis prevention
  - Clinical data requirements
Surgical heart valve substitute hazard analysis example (informative)
- Hazards, foreseeable sequence of events, hazardous situations, and associated harms
In vitro procedures for testing unstented or similar valves in compliant chambers (informative)
- General
- Compliant chamber specifications
- Test procedures using compliant chambers
  - Pulsatile-flow pressure difference
  - Pulsatile-flow regurgitation
  - Reference valves for hydrodynamic testing
  - Wear/durability
Preclinical in vivo evaluation (informative)
- General
- Disposition of evaluations
  - General
  - Haemodynamic performance
  - Usability
  - Acoustic characteristics
  - Interference with adjacent anatomical structures
  - Haemolysis
  - Thrombo-embolic events
  - Calcification/mineralization
  - Pannus formation/tissue ingrowth
  - Structural valve deterioration and non-structural dysfunction
  - Assessment of valve and non-valve related pathology
  - Cavitation
Description of the surgical heart valve substitute and system (informative)
- General
- Chemical treatments, surface modifications, or coatings
- Component description
  - General
  - Examples of components of some surgical heart valve substitutes
- Accessories
Examples of components of some surgical heart valve substitutes and systems (informative)
Guidelines for verification of hydrodynamic performance — Pulsatile flow testing (informative)
- General
- Pulsatile-flow testing
  - Measuring equipment accuracy
  - Test apparatus requirements
  - Test procedure
  - Test report
Examples of design specific testing (informative)
- Sewing ring integrity
- Stent creep
- Environmental degradation
- Static pressure; “burst” test
- Calcification (flexible valve)
- Particulate generation
- Effects of device post-dilatation
- Leaflet impingement force (rigid valves)
- Leaflet escape force (rigid valves)
- Sewing ring push-off
- Sewing ring torque (rigid valves)
- Device migration resistance
Fatigue assessment (informative)
- General
- Fatigue crack growth, da/dN, characterization
- Damage tolerance analysis
Methods of evaluating clinical data against objective performance criteria (normative)
- General
- Objective performance criteria methodology
Adverse event classification during clinical investigation (normative)
- General
- Evaluation
- Data collection requirements
- Adverse events
- Adverse device effects
- Device deficiencies
- Classification of causal relationships
- Classification of adverse events
  - General
  - Examples of adverse events
- Follow up of SAEs
- Device-related mortality
Bibliography

ICS

11.040.40

Ersatzvermerk

Dieses Dokument ersetzt ISO 5840-2:2015-09 .

Dieser Artikel wurde geändert durch: ISO 5840-2 AMD 1:2025-03

Normen mitgestalten