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1 1 2 ISBN : - - - - : : , : 3 ( asean Agreement on Medical Device Directive: AMDD).

2 Annex 2: Risk Classification Rules for Medical Devices other than IVD Medical Devices Annex 3: Risk Classification Rules for IVD Medical Devices

3 4.

4 AMDD: Annex 2: Risk Classification Rules for Medical Devices other than IVD Medical Devices - .. AMDD: Annex 3: Risk Classification Rules for IVD Medical Devices 6 7.

5 ( ) ( ) ( ) ( )

6 8 (biological effect).

7 (calibrator) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) (active medical device)

8 (elements) (stand alone software) ( ) (active therapeutic device) (active device intended for diagnosis)

9 (information) 9 (implantable medical device) (partially or wholly absorbed)

10 (invasive medical device)