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MS 2367:2010 Performance evaluation of in vitro diagnostic medical devices

MS 2367:2010 Performance evaluation of in vitro diagnostic medical devices
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
ICS 11.100
Standard Number MS 2367:2010
Language:
English
Subject Keywords:
Medical device; In vitro diagnostic (IVD)
First presented to the public:
8/6/2018
Original Publication Date:
1/11/2017
Previously Published By:
Department of Standards Malaysia
Place Of Publication:
Cyberjaya, Selangor
Citation:
Extents:
Number of Pages - 21
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2018-08-06 11:42:30.511
Date Last Updated
2019-01-07 11:24:16.6254
Submitter:
Mohamed Yunus Yusof

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MS 2367:2010 Performance evaluation of in vitro diagnostic medical devices1 2018-08-06 11:42:30.511
Engineering Library USM @ 2017