请问心电图记录纸算不算ISO13485体系的医疗器械? 看体系3.11----instrment ,apparatus,implement,machine,appliance,implant,reagent for in vitro use software,material or other similar or related article,intended by the manufacturer to be used,alone or in combination,for human beings,for one or more of the specific medical purpose 应该可以算是吧?