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DANSK DS/ISO/TR 18112 PDF

DANSK DS/ISO/TR 18112 PDF

Name:
DANSK DS/ISO/TR 18112 PDF

Published Date:
02/23/2006

Status:
[ Withdrawn ]

Description:

Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary of regulatory requirements for information supplied by the manufacturer

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Czech version):
200 business days
SKU:
dansk-ds-iso-tr-18112_2680422
Choose Document Language:
47.40 €
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SAME AS ISO/TR 18112 * W/D NO S/S

This Technical Report summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.

Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.

Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.

Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison.

IVD medical devices for self-testing are excluded.


Edition : 06
File Size : 1 file , 1.2 MB
Number of Pages : 130
Product Code(s) : DS-121, DS-121
Published : 02/23/2006

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