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MS 2367:2010 (CONFIRMED:2015)
Performance evaluation of in vitro diagnostic medical devices
This Malaysian Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
1st Confirmation
• (none) / (none) / (none)
PDF
24/04/2019
21
NSC 18 - Medical Devices and Facilities for Healthcare
11.100
30.00