Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-52: AAMI / ANSI EC12:2000/(R)2010, Disposable ECG electrodes. (Cardiovascular)
Date of Standard: 2000. |
| Addresses of Standards Organizations: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
| |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Disposable ECG Electrodes |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
ANSI/AAMI EC12:2000 is recognized in the whole except for the following items:
a. With regard to the use of symbols from AAMI/ISO TIR 15223, the NOTE in section 4.1 of EC12:2000 is not recognized since it conflicts with 21 CFR 801.15(c), which requires the use of the English language, except in Puerto Rico.
b. With regard to pre-attached leadwire safety, section 5.3.2 of EC12:2000 is not recognized. Instead, please comply with the mandatory Performance Standard for Electrode Lead Wires and Patient Cable, promulgated under 21 CFR 898. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2360 |
Electrode, Electrocardiograph |
Class 2 |
DRX |
| |
|
| Relevant Guidance: |
| Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes, issued 10/04/2007 |
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| FDA Technical Contacts: |
| Charles Ho, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1318 |
| Silver Spring MD 20993 |
| 301/796-6320 |
| Email: charles.ho@fda.hhs.gov |
|
| Sharon Lappalainen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 3628 |
| Silver Spring MD 20993 |
| 301/796-6322 |
| Email: sharon.lappalainen@fda.hhs.gov |
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