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GB/T 16886.14-2003 PDF in English


GB/T 16886.14-2003 (GB/T16886.14-2003, GBT 16886.14-2003, GBT16886.14-2003)
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GB/T 16886.14-2003: PDF in English (GBT 16886.14-2003)

GB/T 16886.14-2003
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
GB/T 16886.14-2003 / ISO 10993-14.2001
Biological Evaluation of Medical Devices -
Part 14. Identification and Quantification
of Degradation Products from Ceramics
(ISO 10993-14.2001, 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 Test Procedures ... 8
5 Analysis of Filtrate ... 17
6 Test Report ... 17
Bibliography ... 19
Foreword
This Part of GB/T 16886 equivalently adopts the international standard ISO 10993-
14.2001 Biological Evaluation of Medical Devices – Part 14. Identification and
Quantification of Degradation Products from Ceramics.
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 Standard was proposed by China Food and Drug Administration.
Biological Evaluation of Medical Devices -
Part 14. Identification and Quantification
of Degradation Products from Ceramics
1 Scope
This Part of GB/T 16886 specifies two methods of obtaining solutions of degradation
products from ceramics (including glasses) for the purposes of quantification. It also
gives guidance on the analysis of these solutions in order to identify the degradation
products. Because of the generalized nature of this Part of GB/T 16886, product
specific standards, when available, that address degradation product formation under
more relevant conditions of use, should be considered first.
This Part of GB/T 16886 considers only those degradation products generated by a
chemical dissociation of ceramics during in vitro testing. No degradation induced by
mechanical stress or external energy is covered. It is noted that while ISO 6872 and
ISO 9693 cover chemical degradation tests, they do not address the analysis of
degradation products.
Because of the range of ceramics used in medical devices and the different
requirements for accuracy and precision of the results, no specific analytical
techniques are identified. Further, this Part of GB/T 16886 provides no specific
requirements for acceptable levels of degradation products.
Although these materials are intended for biomedical applications, the biological
activity of these degradation products is not addressed in this Part of GB/T 16886.
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,
parties who reach an agreement based on this Part are encouraged to study if the
latest versions of these documents are applicable. For undated references, the latest
edition of the referenced document applies.
GB/T 6682 Water for Laboratory Use – Specifications (GB/T 6682-1992, neq ISO
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.