BH GSO ISO/TS 10993-19:2017

ISO/TS 10993-19:2006
Bahraini Standard   Current Edition · Approved on 21 June 2017

Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials

BH GSO ISO/TS 10993-19:2017 Files

English 15 Pages
Current Edition Reference Language

BH GSO ISO/TS 10993-19:2017 Scope

This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18. The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2).

Best Sellers From Health Sector

GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes
BH GSO 2017:2023
GSO 2017:2023 
Bahraini Standard
Personal Care and Baby Wet Wipes
BH GSO 2241:2023
GSO 2241:2023 
Bahraini Standard
Cosmetic Products - Body Cleaners
GSO 2241:2023
 
Gulf Standard
Cosmetic Products - Body Cleaners

Recently Published from Health Sector

GSO ISO 12219-9:2025
ISO 12219-9:2019 
Gulf Standard
Interior air of road vehicles — Part 9: Determination of the emissions of volatile organic compounds from vehicle interior parts — Large bag method
GSO ASTM E3032:2025
ASTM E3032:22 
Gulf Standard
Standard Guide for Climate Resiliency Planning and Strategy
GSO ASTM E3356:2025
ASTM E3356:22 
Gulf Standard
Standard Guide for Stakeholder Engagement on Environmental Risk Management and Climate
GSO ISO 12219-1:2025
ISO 12219-1:2021 
Gulf Standard
Interior air of road vehicles — Part 1: Whole vehicle test chamber — Specification and method for the determination of volatile organic compounds in cabin interiors