GB/T 21709.14-2009
Active
GB/Z 42246-2022
Active
National standards
GB/Z 42246-2022 Nanotechnologies—Guideline on genotoxicity test methods for nanomaterials
GB/Z 42246-2022 Nanotechnologies—Guideline on genotoxicity test methods for nanomaterials
Basic Information
Standard Code:
GB/Z 42246-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Integrated services in the fields of medicine, health, and labor protection
ICS Name:
Pharmaceutical Science
Publish Date:
2022-12-30
Implement Date:
2023-07-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国纳米技术标准化技术委员会(SAC/TC 279)
Pages:
16 pages
Scope
本文件提供了纳米材料遗传毒性作用机制、样品制备和表征以及体外和体内试验方法选择策略。本文件适用于纳米材料、含纳米材料的药物（纳米药物)及医疗器械产品的潜在遗传毒性评价。
Development Information
Drafting Units:
中国食品药品检定研究院、国家纳米科学中心
Drafting Persons:
文海若、陈亮、邵安良、徐丽明、吴晓春
Referenced Standards
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 30544.4-2019 Nanotechnologies—Vocabulary—Part 4:Nanostructured materials
GB/T 32269-2015 Nanotechnologies—Terminology and definitions for nano-objects—Nanoparticle, nanofibre and nanoplate
GB/T 41316-2022 Guidelines for the characterization of dispersion stability
GB/T 39261-2020 Nanotechnologies—Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
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