What is ISO/TS 10993‑19 about?
ISO/TS 10993 discusses the biological evaluation of medical devices. ISO/TS 10993‑19 lays out a compilation of parameters and test methods that can be useful for the identification and evaluation of the physical. Physical is Physico-chemical, morphological, and topographical (PMT) properties of materials in finished medical devices. ISO/TS 10993 helps in assessing the overall biological evaluation of a medical device.
Such an assessment is limited to those properties that are relevant to the biological evaluation. And is limited to the medical device’s intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.
Chemical characterization of materials is covered by ISO 10993-19.
Note 1: ISO/TS 10993 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.
Note 2: The ISO 10993 series is not applicable when the material or device is not in contact with the body directly or indirectly.
Who is ISO/TS 10993‑19 for?
ISO/TS 10993‑19 on Physico-chemical, morphological, and topographical characterization of materials is useful for:
- Suppliers of material used in medical devices
- Medical devices manufacturers
- Medical device test centres
- Regulatory authorities
Why should you use ISO/TS 10993‑19?
The identification and evaluation of the Physico-chemical, morphological, and topographical properties of materials used in a finished medical device. Physico-chemical is related to physical chemistry, morphological relating to the shape, contours, and microstructural organization.
ISO/TS 10993‑19 guideline helps you with characterization procedure, qualitative information, material equivalence, quantitative assessment, characterization parameters and methods, and reporting of data obtained for Physico-chemical, morphological, and topographical characterization of materials.
This helps in determining the biological evaluation of that device and its materials. It helps in screening potential new materials, and/or processes for suitability in a medical device for a proposed clinical application.
What’s changed since the last update?
PD ISO/TS 10993‑19:2020 supersedes ISO 10993‑19:2006, which has been withdrawn. PD ISO/TS 10993‑19:2020 has some technical changes with respect to ISO 10993‑19:2006. These include:
- Errors identified in the revision and commenting processes have been corrected.
- Table 1 (on methodology abbreviations) has been updated and moved to Annex A
- Table 2 (on examples of relevant methodologies and parameters) has been updated, moved to Annex A, and split into two tables: one listing typical methods, and one listing other methods (i.e., Those that are rarely used)
- Pointers to ISO 10993-19:2020, Annex C has been added to 5.3 and Annex A, where material equivalence is discussed.
- Pointers to ISO/TR 10993-22 for information on nanomaterials have been added to 5.3 and Table A.3.
