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ČSN EN ISO 18113-5-ed.2 (857027)
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Translate name
STANDARD published on 1.11.2024
The information about the standard:
Designation standards: ČSN EN ISO 18113-5-ed.2
Classification mark: 857027
Catalog number: 519958
Publication date standards: 1.11.2024
SKU: NS-1203258
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN
The category - similar standards:
Annotation of standard text ČSN EN ISO 18113-5-ed.2 (857027):
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document does not apply to:
- a) instructions for instrument servicing or repair;
- b) IVD reagents, including calibrators and control materials for use in control of the reagent;
- c) IVD instruments for professional use
Preview of the standard ČSN EN ISO 18113-5-ed.2 (857027)
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