Standard: AAMI EC53

ECG CABLES AND LEADWIRES

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 covers TRUNK CABLES and PATIENT LEADWIRES used to acquire surface electrocardiographic (ECG) monitoring signals for cardiac monitors/telemetry transmitters (ANSI/AAMI/IEC 60601-2-27), diagnostic electrocardiographs (ANSI/AAMI/IEC 60601-2-25) and ambulatory ECG recorders/event recorders (ANSI/AAMI/IEC 60601-2-47). In the broadest sense, this standard applies to any ECG DEVICE that uses PATIENT LEADWIRES and possibly ECG TRUNK CABLES to acquire surface electrocardiographic signals.

This standard covers both disposable and reusable PATIENT LEADWIRES as well as TRUNK CABLES (generally considered to be reusable). The concept of "disposable" applies to products intended to be used for a single PATIENT stay, typically up to 7 days (SINGLE-PATIENT USE) as well as to products intended to be used one time, typically a few hours (SINGLE USE). For terminological consistency, the concept of "reusable" is referred to as MULTI-PATIENT USE.

Some PATIENT LEADWIRES and TRUNK CABLES used for recording applications might not be intended to be DEFIBRILLATOR-PROOF, but otherwise must meet all the requirements in this standard. Such PATIENT LEADWIRES and TRUNK CABLES are included within the scope of this standard but must be clearly labelled as not being DEFIBRILLATORPROOF.

The tests in this standard allow MANUFACTURERS to verify compliance of their products to this standard's specifications. These tests are not intended to be performed by OPERATORS or RESPONSIBLE ORGANIZATIONS

ECG TRUNK CABLES and PATIENT LEADWIRES used in applications that require special characteristics, such as a magnetic resonance imaging (MRI) suite, are excluded from this standard. TRUNK CABLES and PATIENT LEADWIRES covered by this standard might support physiologic functions in addition to ECG monitoring, such as respiration monitoring by impedance pneumography. However, the TRUNK CABLE and PATIENT LEADWIRES must meet all of the requirements of this standard, unless a requirement is specifically excluded.

 

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami ec53
Publish Date: 2013-01-01
Page Count: 21
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

This Standard References

Showing 3 of 3.


Standards That Reference This Standard

Showing 2 of 2.


Advertisement
Advertisement
Advertisement
Advertisement