Rehabilitation Medical Equipment CE Certification Testing
LeanMed - Active-Passive Therapy Rehabilitation System
JJR Testing Comments:
The risk level of rehabilitation products mainly determined by the initiative and passivity of the function. Usually CE DOC applied to low risk products.
Most rehabilitation products do not directly contact the skin, so biocompatibility testing is not mandatory according to the directives and regulations, but risks also exist. Most of Manufacturers choose to do the test to ensure product quality voluntarily.
Product Category:
Products: active- passive therapy rehabilitation system
Product Category:
EU：class Ⅱa
US: classⅡ
CHN：class II
Testing /Service capability:
EMC | IEC60601-1-2:2014 |
Safety | IEC60601-1:2005+A1:2012 |
Biosafety | ISO10993-5:2009 ISO10993-10:2010 |
And CFDA/NMPA registration in China.
Turnaround Time: 8-10 weeks
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