GSO EN 13532:2021

EN 13532:2002
Gulf Standard   Current Edition · Approved on 01 July 2021

General requirements for in vitro diagnostic medical devices for self-testing

GSO EN 13532:2021 Files

GSO EN 13532:2021 Scope

This standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2063:2023
 
Gulf Standard
Cosmetic Products - Hair Conditioner (Balsam)
GSO 1223:2023
 
Gulf Standard
Cosmetic Products-Deodorants

Recently Published from Health Sector

GSO ISO 10993-10:2024
ISO 10993-10:2021 
Gulf Standard
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
GSO ISO 21649:2024
ISO 21649:2023 
Gulf Standard
Needle-free injection systems for medical use — Requirements and test methods
GSO ISO 15854:2024
ISO 15854:2023 
Gulf Standard
Dentistry — Casting and baseplate waxes
GSO IEC TR 60878:2024
IEC TR 60878:2022 
Gulf Standard
Graphical symbols for electrical equipment in medical practice