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GB/T 16886.15-2003 English PDF (GBT16886.15-2003)

GB/T 16886.15-2003 English PDF (GBT16886.15-2003)

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GB/T 16886.15-2003: Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys

GB/T 16886.15-2003
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 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
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,

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