GB/T 42216.4-2024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4部分:原位检测技术.pdf

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GB/T 42216.4-2024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4部分:原位检测技术.pdf

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ICS11.100.10

CCSC30

中华人民共和国国家标准

GB/T42216.4—2024/ISO20166-4:2021

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4部分:原位检测技术

Molecularinvitrodiagnosticexaminations—Specificationsfor

pre⁃examinationprocessesforformalin⁃fixedandparaffin-

embedded(FFPE)tissue—Part4:Insitudetectiontechnique

(ISO20166⁃4:2021,IDT)

2024⁃08⁃23发布2025⁃03⁃01实施

国家市场监督管理总局

发布

国家标准化管理委员会

GB/T42216.4—2024/ISO20166⁃4:2021

目次

前言··························································································································Ⅲ

引言··························································································································Ⅳ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4通则·······················································································································7

5实验室外部··············································································································8

5.1标本采集···········································································································8

5.1.1概述············································································································8

5.1.2标本供体/患者的信息

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