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  • BSI
    BS EN ISO 18113-2:2011 In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use
    Edition: 2012
    $435.35
    / user per year

Description of BS EN ISO 18113-2:2011 2012

This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use.

This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

This part of ISO 18113 can also be applied to accessories.

This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.

This part of ISO 18113 does not apply to

  1. IVD instruments or equipment,

  2. IVD reagents for self-testing.



Standard NumberBS EN ISO 18113-2:2011
TitleIn vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic reagents for professional use
StatusWithdrawn
Publication Date2012-01-31
Withdrawn Date2024-06-12
ReplacesBS EN ISO 18113-2:2009
Replaced ByBS EN ISO 18113-2:2024
Identical National Standard OfISO 18113-2:2009, EN ISO 18113-2:2011
CorrectsBS EN ISO 18113-2:2011
DescriptorsReagent solutions, Clinical laboratory equipment, Health service personnel, Medical equipment, Labels, Containers, Labelling (process), Diagnosis (medical), Instructions for use, Diagnostic reagents, Product information
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 77328 0
PublisherBSI
Pages24

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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