GB/Z 44314-2024 生物技术 生物样本保藏 动物生物样本保藏要求

ICS07.080

CCSC04

中华人民共和国国家标准化指导性技术文件

GB/Z44314—2024/ISO/TS20388：2021

生物技术生物样本保藏

动物生物样本保藏要求

Biotechnology—Biobanking—

Requirementsforthebiobankingofanimalbiologicalmaterial

（ISO/TS20388：2021，Biotechnology—Biobanking—Requirementsfor

animalbiologicalmaterial，IDT）

2024⁃08⁃23发布2024⁃08⁃23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/Z44314—2024/ISO/TS20388:2021

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·················································································································3

4.1一般要求···········································································································3

4.2伦理要求···········································································································3

4.3健康和安全········································································································4

5生物样本的采集········································································································4

5.1采集前··············································································································4

5.2采集·················································································································6

6生物样本及相关数据的运输·························································································8

7接收·······················································································································9

8生物样本的制备和保存·······························································································9

9生物样本的储存······································································································10

10生物样本的分发、销毁及弃用····················································································10

10.1分发··············································································································10

10.2销毁和弃用·····································································································10

11信息采集··············································································································10

附录A（资料性）动物生物样本数据采集表（示例）·····························································11

附录B（资料性）不同性质和体型动物的采集方法·····························································13

B.1不同动物保定方法·····························································································13

B.2固体组织样本采集示例·······················································································13

B.3血液样本采集方法示例·······················································································13

B.4尿液样本采集方法示例·······················································································14

B.5反刍动物和小型哺乳动物乳样采集方法示例····························································14

B.6其他样本采集方法示例·······················································································15

附录C（资料性）生物样本转移协议或其他等效文件信息····················································16

附录D（规范性）生物样本采集、制备和保存方法·······························································17

参考文献····················································································································19

Ⅰ

GB/Z44314—2024/ISO/TS20388:2021

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/TS20388：2021《生物技术生物样本保藏动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）、中国科学院动物研究所、上海生物芯片有限公司、中国合格评定国家认可中

心、中国科学院水生生物研究所、中国食品发酵工业研究院有限公司、首都医科大学附属北京友谊医

院、上海交通大学医学院附属仁济医院、中国科学院昆明动物研究所、复旦大学、中国计量科学研究院、

青岛华大智造科技有限责任公司、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）、北京市畜牧总站、北京林业大学、复旦大学附属中山医院。

本文件主要起草人：徐讯、李启沅、郜恒骏、吴静静、张小燕、王桃、陈曲波、郝捷、赵同标、李军燕、

王晓龙、危金谱、潘鲁湲、王博、张允、康晓楠、尹婷婷、杨亚军、刘姗姗、王晶、王萌萌、傅博强、田桢干、

陆晔、杨宇泽、张立、乔格侠、李健、彭立人、徐燕萍、徐基良、王然、李卡、杜思琦。

Ⅲ

GB/Z44314—2024/ISO/TS20388:2021

引言

本文件包含了要求和建议，以使处理动物生物样本的生物样本库能够证明其有能力进行样本库的

操作，并有能力为研究和开发提供适当质量的动物生物样本和相关数据。

本文件支持维护动物福祉的过程，因为它植根于三个R原则：“替代、减少和改进对动物的

[18]

使用”。

本文件的使用有助于确保动物生物样本的质量和在ISO20387应用下研究结果的可靠性。

本文件中可以使用以下能愿动词：

——“应”表示要求；

——“宜”表示建议；

——“可”表示允许；

——“能”表示一种可能性或能力。

Ⅳ

GB/Z44314—2024/ISO/TS20388:2021

生物技术生物样本保藏

动物生物样本保藏要求

1范围

本文件规定了动物生物样本（不包括人类）采集、接收、制备、保存、运输、储存、分发、销毁和弃用的

要求。此类资源包括固体组织样本、液体和相关细胞、排泄物及相关数据。

本文件适用于研发用生物样本或/和相关数据，并适用于从生物样本中获取的生物分子，如核酸、

蛋白质和代谢物。

本文件适用于所有进行研究和开发生物样本库的组织机构。

本文件不适用于用于食品或饲料生产的生物样本、为食品或饲料生产或治疗用途进行的实验室研

究或以上结合用途。

本文件不适用于建立源自动物生物样本的细胞系。

注：国际、国内和地区的法规或要求也适用于本文件中的特定条款。

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，注日期的引用文

件，仅该日期对应的版本适用于本文件；不注日期的引用文件，其最新版本（包括所有的修改单）适用于

本文件。

GB/T37864—2019生物样本库质量和能力通用要求（ISO20387：2018，IDT）

世界卫生组织《实验室生物安全手册（第四版）》（Laboratorybiosafetymanual.WorldHealthOrgani‐

zation，4thedition，2020)

3术语和定义

GB/T37864—2019界定的以及下列术语和定义适用于本文件。

3.1

动物animal

具有感觉和自主运动能力的多细胞的异养生物，其细胞因无细胞壁而不同于绝大多数植物。

3.2

相关数据associateddata

生物样本（3.5）的附属信息，包括但不限于研究数据、表型数据、临床数据、流行病学数据、遗传数

据、分类学数据和生物样本处理过程得到的数据等。

[来源：GB/T37864—2019，3.3，有修改]

3.3

生物样本库biobank

开展生物样本保藏（3.4）的合法实体或其部分。

[来源：GB/T37864—2019，3.5]

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