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GB/T 16886.15-2022 English PDF (GBT16886.15-2022)

GB/T 16886.15-2022 English PDF (GBT16886.15-2022)

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GB/T 16886.15-2022: Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

GB/T 16886.15-2022
ICS 11.100.20
CCS C 30
GB/T 16886.15-2022 / ISO 10993-15:2019
Replacing GB/T 16886.15-2003
Biological Evaluation of Medical Devices – Part 15:
Identification and Quantification of Degradation Products
from Metals and Alloys
(ISO 10993-15:2019, IDT)
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 9
2 Normative References ... 9
3 Terms and Definitions ... 11
4 Degradation Test Methods ... 12
4.1 General ... 12
4.2 Prerequisites ... 13
5 Reagent and Sample Preparation ... 13
5.1 Sample documentation ... 13
5.2 Test solution (electrolyte)... 13
5.3 Preparation of test samples ... 13
6 Electrochemical Tests ... 14
6.1 Apparatus ... 14
6.2 Sample preparation ... 15
6.3 Test conditions ... 15
6.4 Potentiodynamic measurements... 15
6.5 Potentiostatic measurements ... 17
7 Immersion Test ... 18
7.1 Apparatus ... 18
7.2 Sample preparation ... 18
7.3 Immersion test procedure ... 18
8 Analysis ... 19
9 Test Report ... 20
Annex A (Informative) Electrolytes for the Electrochemical Tests ... 22 Annex B (Informative) Schematic Diagram of the Electrochemical Measuring Circuit ... 23 Annex C (Informative) Schematic Drawing of an Electrolytic Cell ... 24
Bibliography ... 25
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 15 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 16886.15-2003 Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys. Compared with GB/T 16886.15-2003, the major technical changes of this Document are as follows besides the structural adjustments and editorial modifications: a) Add the scope of application of the document, that is, the description of "this Document applies to materials that are expected to degrade in vivo and materials that are not expected to degrade" (see Clause 1 of this Edition);
b) Add information on test methods for nanomaterials and other related materials (see 4.1 of this Edition);
c) Add more test solutions (electrolytes) (see 5.2 of this Edition);
d) Add more sample shapes (see 5.3.3 of this Edition);
e) Add the specific content of the immersion test (see Clause 7 of this Edition). This Document equivalently adopts ISO 10993-15:2019 Biological Evaluation of Medical Devices – Part 15: Identification and Quantification of Degradation Products from Metals and Alloys.
This Document made the minimum editorial modifications as follows:
--- Add the NOTEs to Figures 1 and 2.
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 Peking University.
Chief drafting staffs of this Document: Liu Aijuan, Bo Xiaowen, Zheng Yufeng, Liu Chunyue, and Xia Dandan.
The historical editions replaced by this Document are as follows:
Biological Evaluation of Medical Devices – Part 15:
Identification and Quantification of Degradation Products
from Metals and Alloys
1 Scope
This Document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.
This Document applies to materials that are expected and unintended to degrade in vivo and to degradation products that result from chemical changes in the final metallic device during in vitro degradation tests.
This Document does not apply to the evaluation of degradation occurring by purely mechanical processes; the methodology for producing such degradation products is described in the specific product standard, if available. This document does not cover the biological activity of degradation products.
NOTE 1: Due to the nature of the in vitro test, the test results approximate the in vivo behavior of the implant or material. The described chemistry is a means to generate degradation products for further evaluation.
NOTE 2: Pure mechanical degradation mainly produces particulate debris. Although not included in the scope of this Document, such degradation products can cause biological reactions, and perform biological evaluation according to the methods described in other parts of GB/T(Z) 16886. NOTE 3: Due to the wide variety of metallic materials used in medical devices, there is no specific analytical technique to determine the quantification of degradation products. This document does not involve the characterization of trace elements (mass fraction < 10-6) contained in specific metals or alloys, nor does it provide specific requirements for acceptable levels of degradation products. 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.
7 Immersion Test
7.1 Apparatus
7.1.1 Test cells of borosilicate glass, of appropriate sizes, in accordance with ISO 3585, with a means of controlling the bath temperature within ±1 °C.
7.1.2 pH-meter with a sensitivity of ±0.1.
7.2 Sample preparation
The test sample shall be placed in a separate glass container. The size of the glass container should be selected so that an electrolyte volume of less than 1 ml/cm2 of sample surface shall completely cover the sample(s). The test sample shall be totally covered by the electrolyte. Do not risk compromising long-term data through biological (e.g. bacterial, fungal) contamination. For example, the utilized containers may need to be sterile and electrolyte may need to be prepared under aseptic conditions.
The surface area and volume of electrolyte should be sufficient for the intended method of analysis (see Clause 8).
Care should be taken such that the samples do not touch the glass surface except in a minimum support line or point. If the test sample is small, the proper surface area/volume ratio might not be attainable with a single test sample. Therefore, if the test sample shall be made up of two or more pieces, the pieces shall not touch each other.
For test samples with roughened or irregular shapes and therefore difficult to determine the surface area, the user is referred to the discussion in ISO 10993-12 and ISO/TR 10993-22 concerning how such differences can impact the risk assessment.
7.3 Immersion test procedure
Measure the pH of the electrolyte containing the test sample at the start of the test. Then tightly close the test cell to prevent evaporation and maintain at (37 ± 1) °C for (7 ± 0.1) d. Then remove the sample and measure the pH of the residual electrolyte. Certain materials can call for the use of tissue culture (i.e., sterile filtered) grade phosphate buffered saline as the immersion electrolyte.
It can be necessary to conduct immersion tests for a longer period of time if all of the following conditions apply:
a) the alloy is used in a permanent implant
b) the alloy contains constituents that are soluble in the use environment

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