| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
3-52
|
| Standard | |
ANSI AAMI EC12:2000/(R)2015
Disposable ECG electrodes |
|
Scope/Abstract| This standard establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Section 5.3.2 Pre-attached Leadwire Safety |
|
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Section 5.3.2 conflicts with an existing regulation, see Section 898.12 Performance standard listed below.
Section 5.3.2 conflicts with existing final published guidance, see Section 5 Performance Characteristics listed below.
Section 5.3.2 conflicts with another recognized standard, see ANSI/AAMI EC53 listed below. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §870.2360 |
Electrode, Electrocardiograph
|
Class 2
|
DRX
|
|
§882.1320
|
Cutaneous electrode. Electrode, Cutaneous
|
Class 2
|
GXY
|
|
Relevant FDA Guidance and/or Supportive Publications*
21 CFR 898 Performance Standard for Electrode Lead Wires and Patient Cables.
Class II Special Controls Guidance Document: Electrocardiograph Electrodes - Guidance for Industry and Food and Drug Administration Staff, Issued October 2007.
ANSI/AAMI EC53:2013 ECG trunk cables and patient leadwires.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organizations
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
