EMC Requirements for Medical Products: A practical applicationof ANSI/AAMI/IEC 60601-1-2, 3rd Edition
ANSI/AAMI/IEC 60601-1-2 specifies general requirements and tests for electromagnetic compatibility (EMC) of medical electrical equipment and medical electrical systems. To assist medical device manufacturers with the application of the standard, AAMI offered this two-hour webinar event on ANSI/AAMI/IEC 60601-1-2. The program will provided information on how to construct a test plan for medical products, including all detailed requirements of the standard. A case study of a product that was tested to ANSI/AAMI/IEC 60601-1-2 but experienced EMI in the field was presented. Participants learned what information should be provided to FDA when making a declaration of conformity to ANSI/AAMI/IEC 60601-1-2, and also learned what can happen when a device declared to be compliant with the standard experiences a life-threatening EMI failure in the field. Speakers covered the latest information on the status of FDA’s recognition of the 3rd edition of ANSI/AAMI/IEC 60601-1-2.
Individuals responsible for product EMC design, validation, and routine control and evaluation of electromagnetic matters can’t afford to miss out on this program!
PROGRAM-AT-A-GLANCE
- Status of ANSI/AAMI/IEC 60601-1-2
- Edition 2
- Amendment 1
- Edition 3
- Edition 4 and beyond
- An example for a life-supporting product
- The EMC environment
- Power requirements
- Test protocol table of contents
- Background information
- Objective of the test protocol
- Scope of the test protocol
- References
- Responsibility
- Equipment
- Test Articles
- Test Setups
- Tests
- ESD immunity
- Radiated RF immunity
- EFT/burst immunity
- FDA
- Information requested by the supplementary information page for recognition of IEC 60601‑1‑2
- Recognition of ANSI/AAMI/IEC 60601-1-2, 3rd edition
- Medical device EMC recall case study
SPEAKERS
- Jim Conrad, President & Owner, Conrad EMC Consulting
- Convener, IEC SC62A/MT23 on IEC 60601-1-2, Electromagnetic Compatibility of Medical Electrical Equipment
- Member, IEC Subcommittee 62A Chairman’s Advisory Group on the 3rd edition of IEC standard 60601-1, Safety of Medical Electrical Equipment
- Member, IEC Advisory Committee on Electromagnetic Compatibility
- Member, ANSI-accredited Committee C63/SC8/WG 2 on Patient Connected Equipment
- Jeffrey L. Silberberg, Senior Electronics Engineer, FDA, Center for Devices and Radiological Health
- Secretary, IEC SC62A/MT23 on IEC 60601-1-2, Electromagnetic Compatibility of Medical Electrical Equipment
- FDA representative, ANSI-accredited Committee C63 and SC1 on Methods of Measurement; SC5 on Immunity; and SC8 on Medical Devices
- FDA representative, AAMI EMC Committee and AAMI Apnea Monitoring Committee
CD FEES
WEBINAR CD
- Includes handout material and CD.
- $295 for webinar registrants
- $395 for non-registrants
- Please note: Domestic and international shipping rates apply.
THREE WAYS TO PURCHASE
- Phone – 1-877-249-8226 / 240-646-7031 to order with credit card.
- Fax - Select and download the order form and fax to 240-396-5781
- Mail - Select and download the order form and mail with payment to:
EMC 60601 Webinar CD Package
AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
All orders must be prepaid and in U.S. Dollars.
QUESTIONS?
For questions about ordering the CD, please contact AAMI’s Publications at 1-877-249-8226 / 240-646-7031. For questions about CD content, please contact Jeanine Beisel at 703-525-4890, ext. 1212.