Recognition List Number: 023 Publication Date: 05/05/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-77: AAMI / ANSI PC69:2007, Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. (Cardiovascular)
Date of Standard: 2007. |
| 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 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Implantable Cardiac Pacemakers, Implantable Cardioverter Defibrillators |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| National, Horizontal |
| Extent of Recognition: |
Complete Standard
This standard specifies test methods appropriate to many interference frequencies, whether high or low, near or far afield. The standard may specify performance limits or require disclosure of performance in the presence of electromagnetic emitters, where appropriate. It provides manufacturers of electromagnetic emitters with information about the level of immunity to be expected from active implantable cardiovascular devices.
ADDITIONAL NOTES:
1. This standard and the conformance of emitters to the relevant human exposure safety standards and pertinent regulatory emission requirements (e.g., those of the U.S. Federal Communications Commission, or FCC). Compliance with biological safety guidelines does not necessarily guarantee EM compatibility with pacemakers and ICDs. In some cases, the reasonably achievable EM immunity performance for pacemakers and ICDs falls below these biological safety limits.
2. The potential for emitter equipment to interfere with a pacemaker or ICD is complex and depends on several factors including: frequency content of the emitter; modulation format; power of the signal; proximity to the patient; coupling factors; and duration of exposure.
3. This standard addresses the EM compatibility of pacemakers and ICDs up to 3,000 MHz and is divided in several sections: a) 0 Hz ? ¿ < 450 MHz; b) 450 MHz ? ¿ < 3,000 MHz; c) ¿ ? 3,000 MHz. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Class 3 |
NIK |
| Unclassified |
Defibrillator, Implantable, Dual-Chamber |
Class 3 |
MRM |
| Unclassified |
Implantable Cardioverter Defibrillator (Non-Crt) |
Class 3 |
LWS |
| Unclassified |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Class 3 |
LWP |
| Unclassified |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Class 3 |
NKE |
| Unclassified |
Pulse Generator, Permanent, Implantable |
Class 3 |
NVZ |
| Unclassified |
Pulse-Generator, Program Module |
Class 3 |
LOT |
| Unclassified |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Class 3 |
LWO |
| Unclassified |
Pulse-Generator, Single Chamber, Single |
Class 3 |
LWW |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contacts: |
| Mitchell J. Shein |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1316 |
| Silver Spring MD 20993 |
| 301/796-6363 |
| Email: mitchell.shein@fda.hhs.gov |
|
| Lynn Braddock |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1319 |
| Silver Spring MD 20993 |
| 301/796-6355 |
| Email: lynn.braddock@fda.hhs.gov |
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| Seth Seidman |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 1117 |
| Silver Spring MD 20993 |
| 301/796-2477 |
| Email: seth.seidman@fda.hhs.gov |
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