90.93 Standard confirmed Jun 6, 2023
ISO
ISO/TC 194 Biological and clinical evaluation of medical devices
Technical Specification
11.100.20 Biological evaluation of medical devices
This document provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical, i.e. 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 document does neither address the identification or quantification of degradation products nor the evaluation of the physico-chemical properties of the degraded materials, 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 is not applicable when the material or device is not in contact with the body directly or indirectly.
WITHDRAWN
ISO/TS 10993-19:2006
PUBLISHED
ISO/TS 10993-19:2020
90.93
Standard confirmed
Jun 6, 2023