Source: http://codeofchina.com/standard/GBT16886.3-2008.html
Timestamp: 2019-09-15 10:47:05
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GB/T 16886.3-2008 English Version, GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity (English Version) - Code of China
Position: Chinese Standard in English/GB/T 16886.3-2008
GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity (English Version)
Standard No.: GB/T 16886.3-2008 Status: to be superseded remind me the status change
Word Count: 6000 words Price(USD): 130.0 remind me the price change
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Detail of GB/T 16886.3-2008
Introduction of GB/T 16886.3-2008
Contents of GB/T 16886.3-2008
Standard No.: GB/T 16886.3-2008
English Name: Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity
Chinese Name: 医疗器械生物学评价 第3部分：遗传毒性、致癌性和生殖毒性试验
Issued by: AQSIQ SAC
Superseded by: GB/T 16886.3-2019
Superseding: GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
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
*GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
*GB/T 16886.6-2015 Biological evaluation of medical devices―Part 6:Tests for local effects after implantation
*GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
Referred in GB/T 16886.3-2008:
GB/T 16886.3-2008 is referred in:
GB/T 16886.3-2008, GB 16886.3-2008, GBT 16886.3-2008, GB/T16886.3-2008, GB/T 16886.3, GB/T16886.3, GB16886.3-2008, GB 16886.3, GB16886.3, GBT16886.3-2008, GBT 16886.3, GBT16886.3