GB/T 16886.15-2003 English PDF (GB/T16886.15-2003)

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