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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. In vitro diagnostic reagents for professional use
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immediate downloadReleased: 2021-08-11
21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. In vitro diagnostic reagents for professional use

21/30416033 DC

BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 2. In vitro diagnostic reagents for professional use

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Standard number:21/30416033 DC
Pages:19
Released:2021-08-11
Status:Draft for Comment
DESCRIPTION

21/30416033 DC


This standard 21/30416033 DC BS EN ISO 18113-2. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) is classified in these ICS categories:
  • 11.100.10 In vitro diagnostic test systems

This document specifies requirements for information supplied by the manufacturer of IVD reagents, calibrators and controls intended for professional use.

This document can also be applied to accessories.

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

This document does not apply to:

  1. IVD instruments or equipment;

  2. IVD reagents for self-testing.