| Item: |
Final |
| Document
Type: |
AAMI/ American National Standard |
| Abstract: |
Establishes minimum safety and performance requirements for electrocardiographic (ECG) heart rate and waveform monitors. Includes 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 rate-dependent phenomena: cardiac standstill, bradycardia, tachycardia.
|
| Format: |
Print or Electronic |
| Number
of Pages: |
79 |
| Publication
Date: |
10/25/2002
|
|
Availability: | Actual |
|
Price (Member/Nonmember): |
$55/$110
|
|
PDF Price (Member/Nonmember): |
$55/$110
|
| Download Information: |
Errata available for free download from AAMI Website. |
| Web Download Location : |
Download errata (62KB pdf file)#http://www.aami.org/standards/downloadables/ec13e0802.pdf# |
| Category: |
Electromedical equipment |
| Subcategory: |
Diagnostic and monitoring |
| Activity: |
STANDARDS |
| Keywords: |
ECG, electromedical equipment, medical electrical equipment, heart rate, waveform, diagnostic, monitoring
|
| Staff
Contact: |
hchoe@aami.org |
| Project
Type: |
Revision |
| Project
Status: |
Completed |
| Document
Status: |
Current |
| Document
Notes: |
Errata sheet combines new errata dated 25-Feb-2008 as well as earlier issued errata dated 19-Dec-2002. |
| Final
Approval Date: |
05/06/2002 |
| Equivalency: |
Equivalency to IEC 62D/60601-2-27/Ed.1: Harmonized |
| Ballot
Committee: |
AAMI/EC/WG 04, Cardiac monitor and diagnostic ECG WG |
| Committee
Author: |
AAMI/EC/WG 04, Cardiac monitor and diagnostic ECG WG |
| Reaffirmation Date: |
12/10/2007 |
| Errata Issued On: |
02/25/2008 |
| FDA Recognition: |
FDA-recognized |
| Extent of Recognition: |
Complete standard |
| Link to FDA List: |
Choose Category "Cardiovascular"
|