标准解读

GB/Z 44313-2024是一个中国国家标准指导性技术文件，专注于生物技术领域中的植物生物样本保藏要求，特别适用于研究与开发目的。该标准详细规定了在收集、处理、存储以及管理植物生物样本过程中应遵循的一系列技术和质量管理规范，以确保样本的质量、稳定性和可追溯性，促进生物多样性的保护和可持续利用，同时支持科学研究与技术进步。以下是该标准的主要内容概览：

  1. 范围与适用对象：明确了标准适用的植物生物样本类型，包括但不限于种子、孢子、组织、细胞系及DNA等，涵盖了从野生到栽培的各种植物资源，强调了其对科研与开发工作的支持作用。

  2. 术语和定义：为确保标准理解的一致性，提供了关键术语的明确定义，如生物样本、保藏、遗传稳定性等。

  3. 样本采集与预处理：阐述了样本采集的基本原则，包括采集时间、部位选择、避免污染的方法等，以及采集后迅速进行的预处理步骤，如清洗、消毒、干燥或冷冻，以维持样本的原始状态和活力。

  4. 质量控制：强调了在样本入库前需进行严格的质量检查，包括形态学、生理生化特性及遗传稳定性的评估，并要求建立详细的样本信息记录体系，确保样本的准确性和可靠性。

  5. 保藏方法与条件：根据植物生物样本的不同类型，规定了适宜的保藏方式，如低温冻存、液氮保存、种子干燥储藏等，并详细说明了相应的环境条件（如温度、湿度）要求，以维持样本长期存活或遗传材料的稳定性。

  6. 样本管理和信息记录：要求建立标准化的样本管理系统，涵盖样本的接收、登记、编码、存储位置标记及数据库建设，确保样本的可追溯性和数据共享的便利性。

  7. 设施与设备：描述了保藏设施应满足的基本条件，包括无菌操作室、低温储存设备、监控系统等，以及对设施维护和环境监测的要求。

  8. 安全与伦理：强调了在样本采集、处理、存储过程中应遵守的相关法律法规，重视生物安全和遗传资源的合法利用，保护知识产权和原产地权益。

  9. 培训与能力建设：提倡对参与样本保藏工作的人员进行专业培训，提升其在生物安全、样本处理技术及信息管理等方面的能力。


如需获取更多详尽信息，请直接参考下方经官方授权发布的权威标准文档。

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文档简介

ICS07.080

CCSC04

中华人民共和国国家标准化指导性技术文件

GB/Z44313—2024/ISO/TS23105：2021

生物技术生物样本保藏用于研究和

开发用途的植物生物样本保藏要求

Biotechnology—Biobanking—Requirementsforthebiobankingof

plantbiologicalmaterialforresearchanddevelopment

（ISO/TS23105：2021，IDT）

2024⁃08⁃23发布2024⁃08⁃23实施

国家市场监督管理总局

国家标准化管理委员会发布

GB/Z44313—2024/ISO/TS23105：2021

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通用要求·················································································································2

5样本采集·················································································································3

5.1一般要求···········································································································3

5.2采集程序···········································································································3

5.3采集容器、工具、用品、试剂和耗材的准备···································································4

5.4样本可追溯性·····································································································5

5.5样本采集···········································································································5

6样本及相关数据的运输·······························································································6

7生物样本的制备和保存·······························································································7

7.1一般要求···········································································································7

7.2剪切、清洗及封装·································································································7

7.3干燥·················································································································7

7.4快速冷冻及低温保存····························································································7

7.5快速干燥···········································································································8

7.6研磨·················································································································8

7.7保护液保存样本··································································································8

8样本的储存··············································································································8

8.1一般要求···········································································································8

8.2储存温度···········································································································9

8.3植物样本的增殖··································································································9

8.4样本的监测·······································································································10

9样本的分发及弃用···································································································10

10信息采集··············································································································10

附录A（资料性）常见植物样本储存温度及保存时限··························································11

附录B（资料性）植物生物样本采集信息表示例································································12

参考文献····················································································································16

Ⅰ

GB/Z44313—2024/ISO/TS23105：2021

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件等同采用ISO/TS23105：2021《生物技术生物样本保藏用于研究和开发用途的植物生

物样本保藏要求》，文件类型由ISO的技术规范调整为我国的国家标准化指导性技术文件。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由全国生物样本标准化技术委员会（SAC/TC559）提出并归口。

本文件起草单位：深圳华大生命科学研究院、上海芯超生物科技有限公司、广东省中医院（广州中

医药大学第二附属医院）、中国合格评定国家认可中心、中国食品发酵工业研究院有限公司、上海生物

芯片有限公司、中国计量科学研究院、首都医科大学附属北京友谊医院、青岛华大智造科技有限责任公

司、中国林业科学研究院林业研究所、中国农业科学院植物保护研究所、上海海关动植物与食品检验检

疫技术中心、上海国际旅行卫生保健中心（上海海关口岸门诊部）、中国科学院昆明植物研究所、北京林

业大学。

本文件主要起草人：徐讯、郜恒骏、李启沅、吴静静、张小燕、刘亚琼、陈曲波、李军燕、张允、王晓龙、

危金谱、王博、刘姗姗、王晶、傅博强、张礼生、王萌萌、郑勇奇、田桢干、张立、张志翔、赵良成、李健、

彭立人、徐燕萍、王然、杨静、李景文、杜思琦。

Ⅲ

GB/Z44313—2024/ISO/TS23105：2021

引言

植物生物样本保藏是植物学及农业生态系统研究、育新品种和良种研发培育、确保遗传多样性和

保护种质资源的基础。生物样本库的采集和准入管理对于优化植物遗传资源具有战略意义。植物生

物样本库以不同的方式获得样本，如从田间采集生物样本、与其他植物生物样本库交换、从供体（主要

是研究人员或育种人员）获得样本。生物样本的采集涵盖多种类型生物样本，包括冷冻植物组织、液体

保存的植物组织、相关提取液或其中的一部分。这些采集通常需要专业的专家来组织和收集，还需要

适当的生物样本处理和储存条件，以保持高质量的采集，并最大限度地发挥优秀成果的潜力。本文件

提供了有关采集、处理、存储、跟踪和分发植物生物样本的指导。

学术机构、非营利性组织和农商企业需要采集、制备、保存、运输和储存植物生物样本的标准。本

文件根据当前可用的技术和科学知识，为植物生物样本库提供了具体要求、指南和有效实践。

Ⅳ

GB/Z44313—2024/ISO/TS23105：2021

生物技术生物样本保藏用于研究和

开发用途的植物生物样本保藏要求

1范围

本文件规定了植物生物样本及相关数据的采集、制备、保存、运输、储存、分发和弃用的要求。

本文件仅适用于能用于进一步处理为生物分子（如核酸、蛋白质和自身代谢产物）的植物样本。

本文件适用于所有从事植物生物样本研究和开发的组织机构。

2规范性引用文件

下列文件中的内容通过文中的规范性引用而构成本文件必不可少的条款。其中，注

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