ISO 18113-2:2022 PDF

ISO 18113-2:2022 PDF

Name:
ISO 18113-2:2022 PDF

Published Date:
09/30/2022

Status:
Active

Description:

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use

Publisher:
International Organization for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

SKU:

Choose Document Language:
$24.3
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This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.

This document can also be applicable to accessories.

This document is applicable to the labels for outer and immediate containers and to the instructions for use.

This document does not apply to:

a) IVD instruments or equipment;

b) IVD reagents for self-testing.


File Size : 1 file , 2.3 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Published : 09/30/2022

History

ISO 18113-2:2022
Published Date: 09/30/2022
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
$24.3
ISO 18113-2:2009
Published Date: 12/15/2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
$21.9

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ISO 15194:2009
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ISO 19001:2013
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In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
$37.2
ISO 15198:2004
Published Date: 07/15/2004
Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
$24.3
ISO 18113-5:2022
Published Date: 09/30/2022
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
$24.3

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