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ISO - DIS 18113-1

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

pending
Organization: ISO
Publication Date: 2 August 2021
Status: pending
Page Count: 59
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

This document does not address language requirements since that is the domain of national laws and regulations.

This document does not apply to:

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

b) packaging list;

c) material safety data sheets / Safety Data Sheets;

d) marketing information (consistent with applicable legal requirements).

Document History

DIS 18113-1
August 2, 2021
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not...
December 15, 2009
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...

References

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