BAS EN ISO 18113-5:2013
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
General Information
Status: Published
No. of pages: 13
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 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.
Lifecycle
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Original document and degree of correspondence
- EN ISO 18113-5:2011, identical
- ISO 18113-5:2009, identical