GB/T 16886.19-2022 PDF English
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Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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Biological evaluation of medical devices -- Part 19: Physio-chemical, morphological and topographical characterization of materials
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GB/T 16886.19-2022: Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16886.19-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.100.20
CCS C 30
GB/T 16886.19-2022 / ISO/TS 10993-19.2020
Replacing GB/T 16886.19-2011
Biological Evaluation of Medical Devices – Part 19.Physic-
Chemical, Morphological and Topographical
Characterization of Materials
(ISO/TS 10993-19.2020, IDT)
Issued on. DECEMBER 30, 2022
Implemented on. JANUARY 01, 2024
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 8
2 Normative References... 8
3 Terms and Definitions... 9
4 General Principles... 9
5 Characterization Procedure... 11
5.1 General... 11
5.2 Qualitative information... 11
5.3 Material equivalence... 12
5.4 Quantitative assessment... 12
6 Characterization Parameters and Methods... 12
7 Reporting of Data Obtained... 13
Annex A (Informative) Principles for Judging Material Equivalence... 15
Bibliography... 20
Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for
Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This Document is Part 19 of GB/T (Z) 16886 Biological Evaluation of Medical Devices. GB/T
(Z) 16886 has published the following parts.
--- Part 1.Evaluation and Testing within a Risk Management Process;
--- Part 2.Animal Welfare Requirements;
--- Part 3.Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity;
--- Part 4.Selection of Tests for Interactions with Blood;
--- Part 5.Tests for in Vitro Cytotoxicity;
--- Part 6.Tests for Local Effects after Implantation;
--- Part 7.Ethylene Oxide Sterilization Residuals;
--- Part 9.Framework for Identification and Quantification of Potential Degradation
Products;
--- Part 10.Tests for Irritation and Skin Sensitization;
--- Part 11.Tests for Systemic Toxicity;
--- Part 12.Sample Preparation and Reference Materials;
--- Part 13.Identification and Quantification of Degradation Products from Polymeric
Medical Devices;
--- Part 14.Identification and Quantification of Degradation Products from Ceramics;
--- Part 15.Identification and Quantification of Degradation Products from Metals and
Alloys;
--- Part 16.Toxicokinetic Study Design for Degradation Products and Leachable;
--- Part 17.Establishment of Allowable Limits for Leachable Substances;
--- Part 18.Chemical Characterization of Medical Device Materials within a Risk
Management Process;
--- Part 19.Physic-Chemical Morphological and Topographical Characterization of
Materials;
--- Part 20.Principles and Methods for Immunotoxicology Testing of Medical Devices;
--- Part 22.Guidance to Nanomaterials.
This Document replaced GB/T 16886.19-2011 Biological Evaluation of Medical Devices - Part
19.Physic-Chemical, Morphological and Topographical Characterization of Materials.
Compared with GB/T 16886.19-2011, the major technical changes of this Document are as
follows besides the structural adjustments and editorial modifications.
a) Add the basic principles of chemical characterization and physicochemical,
morphological and topographical (PMT) in judging equivalence (see Clause 4 of this
Edition; Clause 5 of the 2011 Edition);
b) Add the content of "methodological abbreviations" (see Table A.1 of this Edition; Table
1 of the 2011 Edition);
c) Add the content of "characteristic parameters and method examples"; and divide Table 2
of the 2011 Edition into two tables. one lists typical methods; and the other lists other
methods (that is, less used methods) (see Table A.2 and Table A.3 of this Edition; Table
2 of the 2011 Edition).
This Document equivalently adopts ISO/TS 10993-19.2020 Biological Evaluation of Medical
Devices – Part 19.Physic-Chemical, Morphological and Topographical Characterization of
Materials. The type of document is adjusted into Chinese standard from ISO technical
specification.
Please note some contents of this Document may involve patents. The issuing agency of this
Document shall not assume the responsibility to identify these patents.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on Biological
Evaluation on Medical Device of Standardization Administration of China (SAC/TC 248).
Drafting organizations of this Document. Shandong Institute of Medical Devices and Drug
Packaging Inspection; and Shandong University.
Chief drafting staffs of this Document. Wan Min, Lu Wenbo, Lv Yupeng, Wang Changbin, and
Liu Bing.
The historical editions replaced by this Document are as follows.
--- GB/T 16886.19-2011 was first-time published in 2011;
--- It is the first-time revised hereby.
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., physic‑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.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
ISO 10993-1 Biological evaluation of medical devices – Part 1.Evaluation and testing
within a risk management process
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.
Relating to the physical chemistry (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.
The extent of characterization should reflect the nature and duration of the clinical exposure
and can be useful for risk assessment of the biological safety of the device.
5 Characterization Procedure
Where qualitative material characterization data alone have not provided sufficient data for a
material suitability assessment to be completed, quantitative material characterization data
should be established, documented and subjected to assessment of suitability and risk.
Sufficient quantitative characterization information should be obtained in order to permit an
assessment of the fitness of all of the materials in a finished device for their intended purpose
as part of the overall biological evaluation of the medical device.
6 Characterization Parameters and Methods
Clause 5 indicates the generation of qualitative and quantitative PMT characterization data for
use in the suitability/risk assessment.
7 Reporting of Data Obtained
Test reports should clearly state the purpose of the characterization that has been performed
and, where appropriate, should include the following.
Annex A
(Informative)
Principles for Judging Material Equivalence
In 5.3 characterization data is used in risk assessment to judge equivalence of a proposed
material to an existing clinically established material or finished medical device for the same
type of clinical exposure.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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