Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $305.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $388.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

This International Standard is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.

This International Standard is applicable to both 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 heart valve substitute to be implanted.

This International Standard 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 pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This International Standard imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This International Standard excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

 

Document History

  1. ISO 5840-2:2021 Plus Redline


    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes

    • Historical Version
  2. ISO 5840-2:2021


    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes

    • Most Recent
  3. ISO 5840-2:2015


    Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes

    • Historical Version
  4. ISO 5840:2005

    👀currently
    viewing


    Cardiovascular implants - Cardiac valve prostheses

    • Historical Version