This Part 1 of EN 45502 specifies requirements that are generally applicable to active implantable medical devices
EN 45502-1:2015 includes the following significant technical changes with respect to EN 45502-1:1997:
a) update according to the modified AIMD;
b) update of normative references to the “state of the art”;
c) implementation of usability issues;
d) implementation of links to information security;
e) implementation of elements according to EN 14971:2012;
f) improvement of Clause 14 “Protection from unintentional biological effects being caused by the active implantable medical device”;
g) improvement of Clause 20 “Protection of the active implantable medical device from damage caused by external defibrillators”;
h) improvement of Clause 22 “Protection of the active implantable medical device from changes caused by miscellaneous medical treatments” especially for ultrasonic diagnostic devices.