CEN EN ISO 18113-2 PDF

CEN EN ISO 18113-2 PDF

Name:
CEN EN ISO 18113-2 PDF

Published Date:
06/01/2024

Status:
[ Active ]

Description:

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

Publisher:
European Committee for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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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.


Number of Pages : 26
Published : 06/01/2024

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