1 Scope
This part of GB/T 16886 specifies strategies for hazard identification and tests on medical devices for the following biological aspects:
——genotoxicity;
——carcinogenicity;
——reproductive and developmental toxicity.
This part of GB/T 16886 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
Note: guidance on selection of tests is provided in GB/T 16886.1/ISO 10993-1.
2 Normative References
The following documents contain provisions which, through reference in this part of GB/T 16886, constitute provisions of this part. For dated reference, subsequent amendments to (excluding corrigendum contents), or revisions of, any of these publications do not apply. However, the parties whose enter into agreement according to this Part are encouraged to research whether the latest editions of these documents are applied or not. For undated references, the latest edition of the referenced document applies.
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing (GB/T 16886.1-2001, idt ISO 10993-1: 1997)
GB/T 16886.2 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements (GB/T 16886.2-2000, idt ISO 10993-2: 1992)
GB/T 16886.6 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation (GB/T 16886.6-1997, idt ISO 10993-6: 1994)
GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials (GB/T 16886.12-2005, ISO 10993-12: 2002, IDT)
ISO 10993-18 Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials
OECD 414 Prenatal Development Toxicity Study
OECD 415 One-Generation Reproduction Toxicity Study
OECD 416 Two-Generation Reproduction Toxicity
OECD 421 Reproduction/Developmental Toxicity Screening Test
OECD 451 Carcinogenicity Studies
OECD 453 Combined Chronic Toxicity/Carcinogenicity Studies
OECD 471 Bacterial Reverse Mutation Test
OECD 473 In vitro Mammalian Chromosome Aberration Test
OECD 476 In vitro Mammalian Cell Gene Mutation Test
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 16886.1, GB/T 16886.12 and the following apply.
3.1
carcinogenicity test
test to determine the tumorigenic potential of medical devices, materials and/or extracts using either single or multiple exposures over a major portion of the life span of the test animal
Note: these tests may be designed to examine both chronic toxicity and tumorigenicity in a single experimental study. When chronic toxicity and carcinogenicity are evaluated within a single study, care in study design with emphasis on dose selection should be exercised. This will help to ensure that premature mortality from chronic/cumulative toxicity does not compromise the statistical evaluation of animals that survive until scheduled study termination (i.e. normal life-span).
附录Ａ、附录Ｂ和附录Ｃ。
Foreword i
Introduction iii
1 Scope
2 Normative References
3 Terms and Definitions
4 Genotoxicity Tests
5 Carcinogenicity Tests
6 Reproductive and Developmental Toxicity Tests
7 Test Report
Annex A (Informative) Cell Transformation Test System
Annex B (informative) Rationale of Test Systems
Annex C (informative) Role of Implantation Carcinogenicity Studies
Bibliography
