现行 YY/T 1153-2009
体外诊断用DNA微阵列芯片 体外诊断用DNA微阵列芯片 DNA microarray for in vitro diagnostics
发布日期:2009-12-30
实施日期:2011-06-01
分类信息
研制信息

归口单位: 国家药监局

标准简介

本标准规定了体外诊断用DNA微阵列芯片的术语和定义、要求、试验方法、标志、标签、使用说明、包装、运输和贮存。本标准适用于体外诊断相关的以平面基质为载体的用于定性检测的DNA微阵列芯片产品

相似标准/计划/法规
YY/T 1151-2009
体外诊断用蛋白质微阵列芯片
Protein microarray for in vitro diagnostics
2009-12-30
BS EN ISO 4307-2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
分子体外诊断检查 唾液预检查程序规范 分离的人类DNA
2021-11-04
BS EN ISO 20184-3-2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue-Isolated DNA
分子体外诊断检查 冷冻组织预检验工艺规范
2021-06-01
GB/T 44467-2024
分子体外诊断检验 唾液检验前过程的规范 提取人类DNA
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for saliva—Isolated human DNA
2024-09-29
ISO 4307-2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA
分子体外诊断检验.唾液预检验过程规范.分离的人类DNA
2021-10-22
BS PD CEN/TS 17626-2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for human specimen. Isolated microbiome DNA
分子体外诊断检查 人体样本预检验过程规范 分离微生物组DNA
2021-05-10
BS EN ISO 20186-2-2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated genomic DNA
分子体外诊断检查 静脉全血预检查程序规范
2019-05-10
GB/T 42080.3-2024
分子体外诊断检验 冷冻组织检验前过程的规范 第3部分:分离DNA
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 3: Isolated DNA
2024-09-29
ISO 20184-3-2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
分子体外诊断检验.冷冻组织预检验过程规范.第3部分:分离DNA
2021-05-07
DIN EN ISO 4307
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
分子体外诊断检验.唾液预检验过程规范.分离的人类DNA(ISO 4307-2021);德文版EN ISO 4307:2021
2022-02-01
BS PD CEN/TS 17688-3-2021
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for Fine Needle Aspirates (FNAs)-Isolated genomic DNA
分子体外诊断检查 细针抽吸物(FNA)预检查工艺规范
2021-12-23
BS EN ISO 20166-3-2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue-Isolated DNA
分子体外诊断检查 福尔马林固定和石蜡包埋(FFPE)组织的预检查工艺规范
2019-01-28
GB/T 43279.2-2023
分子体外诊断检验 静脉全血检验前过程的规范 第2部分:分离基因组DNA
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 2:Isolated genomic DNA
2023-11-27
ISO 20186-2-2019
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA
分子体外诊断检查 - 静脉全血预检过程规范 - 第2部分:分离的基因组DNA
2019-02-19
BS PD CEN/TS 17390-2-2020
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood-Isolated DNA
分子体外诊断检查 静脉全血中循环肿瘤细胞(CTC)的预检查程序规范
2020-01-24
BS EN ISO 20186-3-2019
Molecular in-vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood-Isolated circulating cell free DNA from plasma
分子体外诊断检查 静脉全血预检查程序规范
2019-11-27
GB/T 42216.3-2022
分子体外诊断检验 福尔马林固定及石蜡包埋组织检验前过程的规范 第3部分:分离DNA
Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 3:Isolated DNA
2022-12-30
ISO 20166-3-2018
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
分子体外诊断检查 - 福尔马林固定和石蜡包埋(Ffpe)组织的预检过程规范 - 第3部分:隔离Dna
2018-12-14
DIN CEN/TS 17626
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for human specimen - Isolated microbiome DNA; German version CEN/TS 17626:2021
分子体外诊断检验.人类样本预检验过程规范.分离的微生物DNA;德语版CEN/TS 17626:2021
2022-01-01
ISO/TS 7552-2-2024
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood — Part 2: Isolated DNA
分子体外诊断检查 静脉全血中循环肿瘤细胞的预检查方法规范 第2部分:分离的DNA
2024-11-04
阵列芯片诊断DNA

最后更新时间 2025-08-31