ISO 18113-5:2022 PDF

ISO 18113-5:2022 PDF

Name:
ISO 18113-5:2022 PDF

Published Date:
09/30/2022

Status:
Active

Description:

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing

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) instruments intended for self-testing.

This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.

This document can also be applicable to accessories.

This document does not apply to:

a) instructions for instrument servicing or repair;

b) IVD reagents, including calibrators and control materials for use in control of the reagent;

c) IVD instruments for professional use.


File Size : 1 file , 2.2 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Published : 09/30/2022

History

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
ISO 18113-5:2009
Published Date: 12/15/2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
$21.9

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ISO 15194:2009
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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 18113-4:2022
Published Date: 09/30/2022
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
$24.3

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