DANSK DS/EN 13612 PDF

Name:
DANSK DS/EN 13612 PDF

Published Date:
07/01/2002

Status:
[ Active ]

Description:

Performance evaluation of in vitro diagnostic medical devices

Publisher:
Dansk Standard

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

This 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.

Edition :	02
File Size :	1 file , 90 KB
Number of Pages :	18
Product Code(s) :	DS-017, DS-017
Published :	07/01/2002

History

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