BAS EN ISO 18113-1:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
General Information
Status: Published
No. of pages: 53
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 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
Lifecycle
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Original document and degree of correspondence
- EN ISO 18113-1:2011, identical
- ISO 18113-1:2009, identical