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immediate downloadReleased: 2012-01-31
BS EN ISO 18113-1:2011
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
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| Standard number: | BS EN ISO 18113-1:2011 |
| Pages: | 62 |
| Released: | 2012-01-31 |
| ISBN: | 978 0 580 77327 3 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 18113-1:2011
This standard BS EN ISO 18113-1:2011 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 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations.
This part of ISO 18113 does not apply to
IVD devices for performance evaluation (e.g., for investigational use only),
instrument marking,
material safety data sheets.