GSO ISO 18113-3:2024

ISO 18113-3:2022
Gulf Standard   Current Edition · Approved on 14 October 2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

GSO ISO 18113-3:2024 Files

GSO ISO 18113-3:2024 Scope

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.

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
YSMO GSO 2017:2023
GSO 2017:2023 
Yemeni Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 1223:2023
 
Gulf Standard
Cosmetic Products-Deodorants

Recently Published from Health Sector

GSO ISO 8536-13:2025
ISO 8536-13:2024 
Gulf Standard
Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with fluid contact
GSO ISO 18562-3:2025
ISO 18562-3:2024 
Gulf Standard
Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
GSO IEC TS 60601-4-6:2025
IEC TS 60601-4-6:2024 
Gulf Standard
Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
GSO ISO 22112:2025
ISO 22112:2017 
Gulf Standard
Dentistry — Artificial teeth for dental prostheses