GSO ISO 10993-18:2016
Gulf Standard
Current Edition
·
Approved on
22 December 2016
·
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
GSO ISO 10993-18:2016 Files
English
17 Pages
Current Edition
Reference Language
42.23 OMR
GSO ISO 10993-18:2016 Scope
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:
— As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
— Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17).
— Judging equivalence of a proposed material to a clinically established material.
— Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former.
— Screening of potential new materials for suitability in a medical device for a proposed clinical application.
This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
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 11978:2024
ISO 11978:2017
Gulf Standard
Ophthalmic optics — Contact lenses and contact lens care products — Labelling
GSO IEC 63073-1:2024
IEC 63073-1:2020
Gulf Standard
Dedicated radionuclide imaging devices - Characteristics and test conditions - Part 1: Cardiac SPECT
GSO ISO 80601-2-70:2024
ISO 80601-2-70:2020
Gulf Standard
Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
GSO ISO 14708-2:2024
ISO 14708-2:2019
Gulf Standard
Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers