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immediate downloadReleased: 2012-01-31
BS EN ISO 18113-5:2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic instruments for self-testing
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Standard number: | BS EN ISO 18113-5:2011 |
Pages: | 22 |
Released: | 2012-01-31 |
ISBN: | 978 0 580 77330 3 |
Status: | Corrigendum |
DESCRIPTION
BS EN ISO 18113-5:2011
This standard BS EN ISO 18113-5:2011 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 part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.
This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
This part of ISO 18113 can also be applied to accessories.
This part of ISO 18113 does not apply to
instructions for instrument servicing or repair,
IVD reagents, including calibrators and control materials for use in control of the reagent,
IVD instruments for professional use.