GB/T 16886.15-2022 (GB/T16886.15-2022, GBT 16886.15-2022, GBT16886.15-2022) & related versions
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
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GB/T 16886.15-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
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 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 ... 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
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 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
......
GB/T 16886.15-2003
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
GB/T 16886.15-2003 / ISO 10993-15.2000
Biological Evaluation of Medical Devices -
Part 15. Identification and Quantification of
Degradation Products from Metals and Alloys
(ISO 10993-15.2000, IDT)
ISSUED ON. MARCH 05, 2003
IMPLEMENTED ON. AUGUST 01, 2003
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 Degradation Test Methods ... 8
5 Reagent and Sample Preparation ... 9
6 Electrochemical Tests ... 11
7 Immersion Test ... 13
8 Analysis ... 14
9 Test Report ... 14
Annex A (Informative) Schematic Diagram of the Electrochemical Measuring
Circuit ... 16
Annex B (Informative) Schematic Drawing of an Electrolytic Cell ... 17
Annex C (Normative) Electrolytes for the Electrochemical Tests ... 19
Bibliography ... 20
Foreword
This Part of GB/T 16886 equivalently adopts the internationals standard of ISO 10993-
15.2000 Biological Evaluation of Medical Devices – Part 15. Identification and
Quantification of Degradation Products from Metals and Alloys.
The general title of GB/T 16886 is Biological Evaluation of Medical Devices, which
consists of 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 Sensitization;
--- Part 11. Tests for Systemic Toxicity;
--- Part 12. Sample Preparation and Reference Materials;
--- Part 13. Identification and Quantification of Degradation products form 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
Substances.
For other aspects of biological tests, there shall be other parts of standard.
This Part’s Annex C is normative; while Annexes A and B are informative.
Biological Evaluation of Medical Devices -
Part 15. Identification and Quantification of
Degradation Products from Metals and Alloys
1 Scope
This Part provides guidance on general requirements for the design of tests for
identifying and quantifying degradation products from finished metallic medical devices
or corresponding material samples finished as ready for clinical use. It is applicable
only to those degradation products generated by chemical alteration of the finished
metallic device in an in vitro accelerated degradation test. Because of the accelerated
nature of these tests, the test results may not reflect the implant or material behavior
in the body. The described chemical, methodologies are a means to generate
degradation products for further assessments.
This Part of GB/T 16886 is not applicable to degradation products induced by applied
mechanical stress.
NOTE. Mechanically induced degradation, such as wear, may be covered in the appropriate
product-specific standard. Where product-group standards provide applicable product-specific
methodologies for the identification and quantification of degradation products, those standards
should be considered.
Because of the wide range of metallic materials used in medical devices, no specific
analytical techniques are identified for quantifying the degradation products. The
identification of trace elements (< 10-6) contained in the specific metal or alloy is not
addressed in this Part, nor are specific requirements for acceptable levels of
degradation products provided in this Part.
This Part of GB/T 16886 does not address the biological activity of the degradation
products; see instead the applicable clauses of GB/T 16886.1 and ISO 16886-17
[Translator Note. It should be GB/T 16886.17].
2 Normative References
The provisions in following documents become the provisions of this Standard through
reference in this Part of GB/T 16886. For dated references, the subsequent
amendments (excluding corrigendum) or revisions do not apply to this Part, however,
......
| Standard ID | GB/T 16886.15-2022 (GB/T16886.15-2022) | | Description (Translated English) | (Biological Evaluation of Medical Devices-Part 15: Qualitative and Quantitative Degradation Products of Metals and Alloys) | | Sector / Industry | National Standard (Recommended) | | Classification of International Standard | 11.100.20 | | Word Count Estimation | 20,239 | | Date of Issue | 2022-12-30 | | Date of Implementation | 2024-01-01 | | Older Standard (superseded by this standard) | GB/T 16886.15-2003 | | Drafting Organization | Shandong Institute of Medical Devices and Drug Packaging Inspection, Peking University | | Administrative Organization | National Medical Device Biological Evaluation Standardization Technical Committee (SAC/TC 248) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Management Committee | | Standard ID | GB/T 16886.15-2003 (GB/T16886.15-2003) | | Description (Translated English) | Biological evaluation of medical devices--Part 15: Identification and quantification of degradation products from metals and alloys | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 14,123 | | Date of Issue | 2003/3/5 | | Date of Implementation | 2003/8/1 | | Adopted Standard | ISO 10993-15-2000, IDT | | Drafting Organization | National Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Administrative Organization | Biological evaluation of medical devices National Standardization Technical Committee | | Proposing organization | State Drug Administration | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China | | Summary | This Standard specifies the degradation products of qualitative and quantitative tests. This standard applies only to those in vitro degradation products accelerated degradation test by chemical changes in the finished metal instrument produced. |
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