BAS EN ISO 18113-2:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
General Information
Status: Published
No. of pages: 15
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 12.06.2013
Technical committee:
Directive:
98/79/EC, In vitro diagnostic medical devices
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Abstract
ISO 18113-2:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for professional use.
ISO 18113-2:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.
ISO 18113-2:2009 can also be applied to accessories.
ISO 18113-2:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Lifecycle
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Original document and degree of correspondence
- EN ISO 18113-2:2011, identical
- ISO 18113-2:2009, identical