Printed version of this standard is available at Library. To request, please e-mail to adminpk@usm.my and include a copy of this record in your e-mail.
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.
Primary Item Type:
Malaysian Standard
Identifiers:
ISC ISC R - Medical Devices and Facilities for Healthcare