AAMI Publishes Biological Evaluation, Implantable Devices Standards - AAMI 10993-6, AAMI PC69
January 13, 2008 // Published as a news service by IHS
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The Association for the Advancement of Medical Instrumentation (AAMI) published standards addressing biological evaluation and implantable devices.
The first, American National Standards Institute (ANSI)/AAMI/International Organization for Standardization (ISO) 10993-6:2007 - Biological evaluation of medical devices - Part 6: Test for local effects after implantation, is the first major revision to the standard in 12 years, said AAMI.
It is intended to be referenced by medical device developers and consultants who test devices for their clients.
The standard outlines the details that must be taken into consideration when testing the biocompatibility of an implantable device such as a cardiac pacemaker or internal defibrillator.
This is typically done by implanting a test piece of the material comprising the device into a laboratory animal and evaluating that material's effects on the surrounding tissue.
Items covered in the standard include:
- The preparation of test material for implantation.
- Specific test methods.
- Selecting an implantation site.
- Selecting appropriate test animals.
- Length of time a piece of test material should remain implanted.
- Testing conditions.
- Biological evaluation of the test site.
The standard also includes five annexes covering such items as test methods for implantation into subcutaneous tissue, muscle and bone as well as examples of biological effects after implantation.
The standard is intended to address the potential response of the local tissue surrounding an implantable device.
The text of the standard doubled from its previous edition to include additional technical information and guidance.
ANSI/AAMI PC69:2007
AAMI also published ANSI/AAMI PC69:2007 - Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators.
Intended for manufacturers of implantable medical devices and consultants who test implantable devices, the standard specifies test methods related to interference frequencies and their potential effects on implantable devices such as cardiac pacemakers and internal defibrillators.
It requires disclosure of a device's performance issues in the presence of electromagnetic (EM) emitters, where appropriate, and provides manufacturers of EM emitters with information about the level of immunity to be expected from active implantable cardiovascular devices.
This second edition of ANSI/AAMI PC69 includes a test requirement and test method for the 0 Hz to 450 MHz range as well as test requirements and test methods for two therapeutic environments including external defibrillation and electrosurgery.
Source: Association for the Advancement of Medical Instrumentation (AAMI).