Product Product ISO 18113-3:2022
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Description Description

This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.

This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.

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 self-testing.

Standard Number Standard Number ISO 18113-3:2022
Title Title ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments 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
Publisher Publisher PECB Store
Format Format PDF
Delivery Delivery NO
Pages Pages 10
File Size File Size KB