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sklademVydáno: 2022
ISO 18113-4:2022
ISO 18113-4:2022-In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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Anglicky PDF
Immediate download
73.05 €
Francouzsky PDF
Immediate download
73.05 €
Anglicky Hardcopy
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73.05 €
Francouzsky Hardcopy
In stock
73.05 €
Označení normy: | ISO 18113-4:2022 |
Počet stran: | 11 |
Vydání: | 2 |
Vydáno: | 2022 |
Počet stran (Anglicky): | 11 |
Počet stran (Francouzsky): | 11 |
DESCRIPTION
ISO 18113-4:2022
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable to the labels for outer and immediate containers and to the instructions for use. This document does not apply to: a) IVD instruments or equipment; b) IVD reagents for professional use.