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CEN - EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

active, Most Current
Organization: CEN
Publication Date: 1 October 2011
Status: active
Page Count: 62
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

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

a) IVD devices for performance evaluation (e.g., for investigational use only),

b) instrument marking,

c) material safety data sheets.

Document History

EN ISO 18113-1
October 1, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
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...
December 1, 2009
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
A description is not available for this item.

References

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