Product items of the medical device － Requirements for specifications, test methods and performance  
Classific -
ation 
Number  Classification 
Name  Class  Product Category  Specification, Testing Method and Performance  
G.3300  Hearing Aid 1 Air-conduction Hearing Aid According to product characteristics, pre-clinical 
performance reports  should comply with IEC 60601 -
1(Electrical safety test), IEC 60601 -1-
2(Electromagnetic compatibility test) and ANSI  
S3.22(Electroacoustic performance)  or the others  
equivalent international standards.  
I.4040  Medical 
Apparel  1 Disposable Isolation Gown  According to product characteristics, pre-clinical 
performance reports  of the Hydrostatic pressure and 
Impact penetration should comply with CNS 
14798(T5019) P1 level or the others equivalent 
international standards.  
1, 2 Medical Face Masks  The quality requirements report of the Free 
formaldehyde, Forbidden  azo colorants, and 
Migratable fluorescent substances in colored or 
dyed medical face masks should comply with CNS 
14774.  
O.3825  Mechanical 
Walker  1 Walking Frames without 
Accessories  According to product characteristics, pre-clinical 
performance reports  of the Fatigue test, Static 
loading test, Static leg -strength test, Forward 
stability test , Backward stability test  and Sideway s 
stability test  should comply with  CNS 15037 -1, ISO 
11199 -1 or the others  equivalent international 
standards.  
Rollators  According to product characteristics, pre -clinical 
performance reports  of the Forward -direction 
stability test, Backward -direction stability test, 
Sideway -direction stability test, Brake tests, 
Handgrip test, Rubber tip test, Resting seat test, 
Static load ing test, Fatigue test and Final inspection 
should comply with  CNS 15037 -2, ISO 11199 -2 or 
the others  equivalent international standards.  
Walking Tables  According to product characteristics, pre-clinical 
performance reports  of the Forward stability test, 
Backward stability test, Sideways stability test, 
Brake test, Resting seat test, Static strength test, 
Fatigue test and Final inspection  should comply with  
CNS 15037 -3, ISO 11199 -3 or the others  equivalent 
international standards.  
Note: if the product performance/specifications have been described in the identification provisions of 
medical device product items shall  also be submitted.  