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Product Product ISO 18113-2:2022
Price Price USD 69.00
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Description Description

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional use.

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 self-testing.

Standard Number Standard Number ISO 18113-2:2022
Title Title ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
Status Status Published
Publication Date Publication Date 06 Oct 2022
Cross References Cross References
Descriptors Descriptors
ICS ICS 11.100.10
Committee Committee ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ISBN ISBN
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 11
File Size File Size KB