AAMI EC12 : 2000 : R2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
DISPOSABLE ECG ELECTRODES
Hardcopy , PDF
06-09-2019
English
24-08-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Committee representation
Foreword
1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Definitions and abbreviations
4 Requirements
4.1 Labeling requirements
4.2 Performance requirements
4.2.1 Packaging and shelf life
4.2.2 Electrical performance
4.3 Safety requirements
4.3.1 Biological response
4.3.2 Pre-attached leadwire safety
4.4 Adhesive performance (duration of use)
5 Tests
5.1 Labeling
5.2 Performance
5.2.1 Packaging and shelf life
5.2.2 Tests for electrical performance
5.3 Safety
5.3.1 Biological response evaluation
5.3.2 Pre-attached leadwire safety
5.4 Adhesive performance (duration of use)
Annexes
A - Rationale for the development and provisions
of this standard
B - Cited references
Covers minimum labeling, safety, and performance requirements for disposable electrodes for use in diagnostic electrocardiography (ECG) or ECG monitoring.
| Committee |
WG 06
|
| DocumentType |
Standard
|
| Pages |
21
|
| ProductNote |
Reconfirmed 2010
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| AAMI EC53 : 2013 | ECG TRUNK CABLES AND PATIENT LEADWIRES |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
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