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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.10 In vitro diagnostic test systems>21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. In vitro diagnostic instruments for self-testing
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immediate downloadReleased: 2021-08-11
21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. In vitro diagnostic instruments for self-testing

21/30416045 DC

BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Part 5. In vitro diagnostic instruments for self-testing

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Standard number:21/30416045 DC
Pages:17
Released:2021-08-11
Status:Draft for Comment
DESCRIPTION

21/30416045 DC


This standard 21/30416045 DC BS EN ISO 18113-5. 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 instruments intended for self-testing.

This document also applies to apparatus and equipment intended to be used with in vitro diagnostic (IVD) instruments for self-testing.

This document can also be applied to accessories.

This document does not apply to

  1. instructions for instrument servicing or repair;

  2. IVD reagents, including calibrators and control materials for use in control of the reagent;

  3. IVD instruments for professional use.