DZ/T 0101.12-1994
Active
GB/T 42216.1-2022
Active
National standards
GB/T 42216.1-2022 RNAMolecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 1:Isolated RNA
GB/T 42216.1-2022 RNAMolecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 1:Isolated RNA
Basic Information
Standard Code:
GB/T 42216.1-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
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:
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Pages:
21 pages
Scope
本文件提供了在进行分子分析之前的检验前阶段，用于RNA检验的福尔马林固定和石蜡包埋组织(FFPE)标本处理、记录、贮存及取材的指南。本文件适用于分子体外诊断检验，包括医学实验室和分子病理学实验室进行的实验室自建检测项目,也适用于实验室客户、体外诊断开发者和制造商、生物样本库、从事生物医学研究的机构和商业组织以及监管机构。注： 国际、国家及区域法规要求同样适用于本文件涉及的特定内容。
Development Information
Drafting Units:
北京医院、中国合格评定国家认可中心、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、北京大学人民医院、中日友好医院、复旦大学附属肿瘤医院、中国食品药品检定研究院
Drafting Persons:
肖飞、赵晓涛、周亚莉、周晓燕、钟定荣、陈皇、毕春雷、李贺鑫、张文新
Same series standard
GB/T 42216.2-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 2:Isolated proteins
GB/T 42216.3-2022 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 3:Isolated DNA
Referenced Standards
Adopt standards
ISO 20166-1:2018
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