GSO ISO 16038:2022

ISO 16038:2017
Gulf Standard   Current Edition · Approved on 12 May 2022

Male condoms — Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

GSO ISO 16038:2022 Files

English 12 Pages
Current Edition Reference Language
30.59 OMR

GSO ISO 16038:2022 Scope

ISO 16038:2017 provides guidance on using ISO 4074 and ISO 23409 and addresses quality issues to be considered during the development, manufacture, quality verification and procurement of condoms. It encompasses the aspects of quality management systems in the design, manufacture and delivery of condoms with an emphasis on performance, safety and reliability.

Male condoms are either made from essentially natural rubber latex, in which case the requirements of ISO 4074 are applicable, or from synthetic materials and/or blends of synthetic materials and natural rubber latex, in which case the requirements of ISO 23409 are applicable. This document outlines the aspects applicable to both types of condoms with specific clarifications where appropriate.

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