Standard: AAMI 7198

CARDIOVASCULAR IMPLANTS—TUBULAR VASCULAR PROSTHESES

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 International Standard specifies requirements relating to testing, packaging, labeling, and terminology for sterile tubular vascular prostheses intended to replace, bypass, or form shunts between segments of the vascular system in humans.

This International Standard addresses vascular prostheses that are made wholly or partly of materials of: biological origin; synthetic textile materials; and synthetic nontextile materials. In addition, guidance for characterization of compound and composite prostheses is provided. It specifies the designation of materials of manufacture and the construction, and specifies the designation of sizes and dimensions of vascular prostheses. It refers to biological requirements of the materials of construction and of the finished product, taking into account the appropriate part of the horizontal International Standard ISO 10993.

This International Standard also specified the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties declared by the manufacturer. It refers to sterilization of prostheses and specifies requirements for labeling and packaging. It also provides definitions of terms in common use.

This International Standard does not specify all the performance or dimensional characteristics, but it does include methods for verifying that the nominal values disclosed by the manufacturer are within the permitted tolerances. These recommendations do not purport to comprise a complete test program.

For the purposes of this International Standard, the disclosure of test methods, results, and other information on request shall relate solely to requests from a National Regulatory Authority with responsibility for surgical implants.

This International Standard does not apply to human donor tissue devices such as cryopreserved vessels. Also excluded are all patches, pledgets, and stents.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 7198
Publish Date: 1998-01-01
Page Count: 56
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
Advertisement
Advertisement
Advertisement
Advertisement