Standard: AAMI EC13

CARDIAC MONITORS, HEART RATE METERS, AND ALARMS

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 standard establishes minimum safety and performance requirements for electrocardiograph (ECG) heart rate and waveform monitors that are intended for use under the operating conditions specified in this standard. Subject to this standard are all parts of such monitors necessary to:

a) obtain a heart rate indication via noninvasive ECG sensing from the patient’s body;

b) amplify and transmit this signal and display the heart rate and/or ECG waveform; and

c) provide alarms, based on adjustable alarm criteria, upon the sustained occurrence of the following ratedependent phenomena: cardiac standstill, bradycardia, and/or tachycardia.

NOTE-The safety and performance criteria defined in this standard are intended principally for use in design qualification or “type” evaluation by the manufacturer. (Type evaluation is the full battery of tests that must be done on a typical instrument or group of typical instruments to verify that all performance design requirements have been met. It is used to officially establish that a product model’s design has achieved compliance with all standards to which a manufacturer claims compliance.)

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ec13
Publish Date: 2002-01-01
Page Count: 1
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive

This Standard References

Showing 9 of 9.


Advertisement
Advertisement
Advertisement
Advertisement