SS-EN-ISO-18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

SS-EN-ISO-18113-2 - 2011 EDITION - CURRENT
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This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to a) IVD instruments or equipment, b) IVD reagents for self-testing.

To find similar documents by classification:

11.100.10 (In vitro diagnostic test systems)


In vitro diagnostic medical devices

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Designation Name

SS-EN ISO 18113-2:2011

Revision Level

2011 EDITION

Status

Current

Publication Date

Nov. 21, 2011

Language(s)

English

Page Count

28

International Equivalent

EN ISO 18113-2:2011(IDT); ISO 18113-2:2009(IDT)