Standard: AAMI 5840-3

CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

FEATURES & BENEFITS
  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.

This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.

This part of ISO 5840 excludes valve-in-valve configurations and homografts.

This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and ISO 5840:2005 might be relevant and can be considered.

NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 5840-3
Publish Date: 2013-01-01
Page Count: 128
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
Advertisement
Advertisement
Advertisement
Advertisement