FDA indica en el alcance del documento que se aplica a productos sanitarios incluyendo a los productos sanitarios para diagnóstico in vitro. Hace referencia a las familias de normativa IEC 60601 / 80601 y a la IEC 601010-1 para IVD.
Nos da un listado, de A a K, de información que debemos incluir en nuestro 510k:
A. EMC-Related Device Characteristics and Intended Use Environments
B. Assessment of Medical Device Risks
C. Consensus Standards
(1) Non-implantable Medical Devices
(2) Active Implantable Medical Devices (AIMDs)
(3) Special Environments
D. Essential Performance and Immunity Pass/Fail Criteria
(1) Essential Performance
(2) Immunity Pass/Fail Criteria
E. Medical Device Configuration and Functions Tested
F. Results of EMC Testing
G. Allowances
H. Deviations
I. Modifications
J. Common Electromagnetic (EM) Emitters
K. Labeling
