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“ISO 20166:2021 Molecular in vitro diagnostic examinations – Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 4: In situ detection techniques” has been added to your cart. View cart
ISO 18113:2022
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing
CDN $115.00
Description
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.
Edition
2
Published Date
2022-10-06
Status
PUBLISHED
Pages
11
Language
English
Format
Secure PDF
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Abstract
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.
Previous Editions
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