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: PDF in English (GBT 16886.19-2022) GB/T 16886.19-2022
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)
性表征
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.
Biological Evaluation of Medical Devices – Part 19: Physic-
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., 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.
This Document is applicable to the final medical device materials.
This document does neither address the identification or quantification of degradation products
nor the evaluation of the physic-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.
GB/T (Z) 16886 (all parts) is not applicable when the material or device is not in contact with
the body directly or indirectly.
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
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
otherwise represent the final product.
5.3 Material equivalence
As a part of material suitability assessment, a comparison of these data should be made to
determine whether this material is equivalent to that utilized in a device or prototype with the
same clinical exposure/use and having had the same manufacturing and sterilization processes
applied, e.g., established safe and effective use of materials in a product to be used on intact
skin. Annex A gives further guidance on judging material equivalency.
NOTE: Discussion on nanomaterials is presented in ISO/TR 10993-22. See also GB/T 16886.18-2022,
Annex C for more on material equivalence.
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.
5.4 Quantitative assessment
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. This quantitative
characterization information can be usefully compared with data for materials and/or finished
medical devices clinically established as being safe and effective for the intended use. The
characterization information can also be usefully compared to those materials/products found
not to have the required characteristics for this use. This overall evaluation is outside the scope
of this document and combines information gained from many other parts of the GB/T (Z)
16886 (all parts) and utilizes ISO 14971.
6 Characterization Parameters and Methods
Clause 5 indicates the generation of qualitative and quantitative PMT characterization data for
use in the suitability/risk assessment. Table 1 lists properties that are typically assessed for the
characterization of materials, components, or devices. Depending on the material composition,
it can be useful to evaluate for additional properties which are described in Table 2. Additional
information on example methods and references used to characterize the properties are
referenced in Table A.2 and Table A.3.
The characterization parameters used should be selected based on the material or finished
medical device. Due to the diversity of medical devices, it is recognized that not all of the
parameters identified for a material will be relevant for all/some device uses. As noted in GB/T
16886.1-2022, 6.2, the extent of characterization which should be considered is determined by
the invasiveness and duration of clinical exposure in the intended use.
The analyst and material scientist in consultation with the manufacturer’s assessor of the
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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