Draft Medical device product items that shall Accord specification, testing method and performance  
Classification 
Number  Classification 
Name  Class  Product 
Category  Specification, T esting Method and Performance  Implementation 
Date 
O.3825  Mechanical 
Walker  1 Walking 
Frames 
without 
Accessories  According to Product Characteristics, Non-clinical 
performance data of the Fatigue test, Static loading 
test, Static leg -strength test, Forward  stability test 
and Backward stability test  should comply with  CNS 
15037 -1, ISO 11199 -1 or the others  equivalent 
international standards.  One year after 
announcement  
Rollators  According to Product Characteristics, Non-clinical 
performance data 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 loading 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, Non-clinical 
performance data 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.  
G.3300  Hearing Aid 1 Air-
conduction 
Hearing Aid According to Product Characteristics, Non-clinical 
performance data should comply with IEC 60601 -
1(Electrical safety test), IEC 60601 -1-
2(Electromagnetic compatibility test), ISO 10993 -
1(Cytotoxicity), ISO 10993 -5(Sensitization), ISO 
10993 -10(Irritation or Intracutaneous reactivity) and 
ANSI S 3.22(Electroacoustic performance)  or the 
others  equivalent international standards.  One year after 
announcement  
I.4040  Medical 
Apparel  1 Disposable 
Isolation 
Gown  According to Product Characteristics, Non -clinical 
performance data of the Hydrostatic pressure and 
Impact penetration should comply with CNS 
14798(T5019) P1 level or the others equivalent 
international standards.  One year after 
announcement  
 