Detail of GB/T 16886.19-2022

Introduction of GB/T 16886.19-2022

GB/T 16886.19-2022 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials 1 Scope 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 applies to final medical device materials. 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, and the chemical characterization of materials is covered by ISO 10993-18. GB/T (Z) 16886 series is not applicable when the material or device is not in contact with the body directly or indirectly. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process Note: GB/T 16886.1-2022, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, IDT) ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process Note: GB/T 16886.18-2022, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020, IDT) 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-18 and the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: ——IEC Electropedia: available at http://www.electropedia.org/ ——ISO Online browsing platform: available at http://www.iso.org/obp 3.1 physico-chemical relating to the physical chemistry (of materials) 3.2 morphological relating to the shape, contours and microstructural organization (of materials) 3.3 topographical relating to the features of the surface (of materials) 4 General principles Consideration of the PMT characterization of the materials from which a medical device is made, like chemical characterization of materials (addressed in ISO 10993-18), is a necessary step in assessing the biological safety and clinical effectiveness of the device. Both types of characterization are also important in judging equivalence of a) a proposed material to a clinically established material; b) a prototype device to a final device; c) a material or device after a process or manufacturing change, or d) a real-time and/or accelerated device and the non-aged device.

Contents of GB/T 16886.19-2022

Foreword I Introduction III 1 Scope 2 Normative references 3 Terms and definitions 4 General principles 5 Characterization procedure 5.1 General 5.2 Qualitative information 5.3 Material equivalence 5.4 Quantitative assessment 6 Characterization parameters and methods 7 Reporting of data obtained Annex A (Informative) Principles for judging material equivalence Bibliography