GSO ISO 10993-10:2016
Gulf Standard
Current Edition
·
Approved on
22 December 2016
·
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
GSO ISO 10993-10:2016 Files
English
67 Pages
Current Edition
Reference Language
85.35 OMR
GSO ISO 10993-10:2016 Scope
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
This part of ISO 10993 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
c) key factors for the interpretation of the results.
Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
Best Sellers From Health Sector
GSO 1943:2021
Gulf Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 2017:2023
Gulf Standard
Personal Care and Baby Wet Wipes
GSO 2241:2023
Gulf Standard
Cosmetic Products - Body Cleaners
GSO 2302:2022
Gulf Standard
Cosmetic Products – Face Masks
Recently Published from Health Sector
GSO ISO 11608-6:2024
ISO 11608-6:2022
Gulf Standard
Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
GSO ISO 17069:2024
ISO 17069:2020
Gulf Standard
Accessible design — Consideration and assistive products for accessible meeting
GSO ISO 16256:2024
ISO 16256:2021
Gulf Standard
Clinical laboratory testing and in vitro diagnostic test systems — Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
GSO ISO 14708-3:2024
ISO 14708-3:2017
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators