標(biāo)準(zhǔn)解讀

GB/Z 44313-2024是一個(gè)中國國家標(biāo)準(zhǔn)指導(dǎo)性技術(shù)文件，專注于生物技術(shù)領(lǐng)域中的植物生物樣本保藏要求，特別適用于研究與開發(fā)目的。該標(biāo)準(zhǔn)詳細(xì)規(guī)定了在收集、處理、存儲(chǔ)以及管理植物生物樣本過程中應(yīng)遵循的一系列技術(shù)和質(zhì)量管理規(guī)范，以確保樣本的質(zhì)量、穩(wěn)定性和可追溯性，促進(jìn)生物多樣性的保護(hù)和可持續(xù)利用，同時(shí)支持科學(xué)研究與技術(shù)進(jìn)步。以下是該標(biāo)準(zhǔn)的主要內(nèi)容概覽：

  1. 范圍與適用對(duì)象：明確了標(biāo)準(zhǔn)適用的植物生物樣本類型，包括但不限于種子、孢子、組織、細(xì)胞系及DNA等，涵蓋了從野生到栽培的各種植物資源，強(qiáng)調(diào)了其對(duì)科研與開發(fā)工作的支持作用。

  2. 術(shù)語和定義：為確保標(biāo)準(zhǔn)理解的一致性，提供了關(guān)鍵術(shù)語的明確定義，如生物樣本、保藏、遺傳穩(wěn)定性等。

  3. 樣本采集與預(yù)處理：闡述了樣本采集的基本原則，包括采集時(shí)間、部位選擇、避免污染的方法等，以及采集后迅速進(jìn)行的預(yù)處理步驟，如清洗、消毒、干燥或冷凍，以維持樣本的原始狀態(tài)和活力。

  4. 質(zhì)量控制：強(qiáng)調(diào)了在樣本入庫前需進(jìn)行嚴(yán)格的質(zhì)量檢查，包括形態(tài)學(xué)、生理生化特性及遺傳穩(wěn)定性的評(píng)估，并要求建立詳細(xì)的樣本信息記錄體系，確保樣本的準(zhǔn)確性和可靠性。

  5. 保藏方法與條件：根據(jù)植物生物樣本的不同類型，規(guī)定了適宜的保藏方式，如低溫凍存、液氮保存、種子干燥儲(chǔ)藏等，并詳細(xì)說明了相應(yīng)的環(huán)境條件（如溫度、濕度）要求，以維持樣本長期存活或遺傳材料的穩(wěn)定性。

  6. 樣本管理和信息記錄：要求建立標(biāo)準(zhǔn)化的樣本管理系統(tǒng)，涵蓋樣本的接收、登記、編碼、存儲(chǔ)位置標(biāo)記及數(shù)據(jù)庫建設(shè)，確保樣本的可追溯性和數(shù)據(jù)共享的便利性。

  7. 設(shè)施與設(shè)備：描述了保藏設(shè)施應(yīng)滿足的基本條件，包括無菌操作室、低溫儲(chǔ)存設(shè)備、監(jiān)控系統(tǒng)等，以及對(duì)設(shè)施維護(hù)和環(huán)境監(jiān)測的要求。

  8. 安全與倫理：強(qiáng)調(diào)了在樣本采集、處理、存儲(chǔ)過程中應(yīng)遵守的相關(guān)法律法規(guī)，重視生物安全和遺傳資源的合法利用，保護(hù)知識(shí)產(chǎn)權(quán)和原產(chǎn)地權(quán)益。

  9. 培訓(xùn)與能力建設(shè)：提倡對(duì)參與樣本保藏工作的人員進(jìn)行專業(yè)培訓(xùn)，提升其在生物安全、樣本處理技術(shù)及信息管理等方面的能力。


如需獲取更多詳盡信息，請(qǐng)直接參考下方經(jīng)官方授權(quán)發(fā)布的權(quán)威標(biāo)準(zhǔn)文檔。

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ICS07.080

CCSC04

中華人民共和國國家標(biāo)準(zhǔn)化指導(dǎo)性技術(shù)文件

GB/Z44313—2024/ISO/TS23105：2021

生物技術(shù)生物樣本保藏用于研究和

開發(fā)用途的植物生物樣本保藏要求

Biotechnology—Biobanking—Requirementsforthebiobankingof

plantbiologicalmaterialforresearchanddevelopment

（ISO/TS23105：2021，IDT）

2024?08?23發(fā)布2024?08?23實(shí)施

國家市場監(jiān)督管理總局

國家標(biāo)準(zhǔn)化管理委員會(huì)發(fā)布

GB/Z44313—2024/ISO/TS23105：2021

目次

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

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

1范圍·······················································································································1

2規(guī)范性引用文件········································································································1

3術(shù)語和定義··············································································································1

4通用要求·················································································································2

5樣本采集·················································································································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、試劑和耗材的準(zhǔn)備···································································4

5.4樣本可追溯性·····································································································5

5.5樣本采集···········································································································5

6樣本及相關(guān)數(shù)據(jù)的運(yùn)輸·······························································································6

7生物樣本的制備和保存·······························································································7

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

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

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

7.4快速冷凍及低溫保存····························································································7

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

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

7.7保護(hù)液保存樣本··································································································8

8樣本的儲(chǔ)存··············································································································8

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

8.2儲(chǔ)存溫度···········································································································9

8.3植物樣本的增殖··································································································9

8.4樣本的監(jiān)測·······································································································10

9樣本的分發(fā)及棄用···································································································10

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

附錄A（資料性）常見植物樣本儲(chǔ)存溫度及保存時(shí)限··························································11

附錄B（資料性）植物生物樣本采集信息表示例································································12

參考文獻(xiàn)····················································································································16

Ⅰ

GB/Z44313—2024/ISO/TS23105：2021

前言

本文件按照GB/T1.1—2020《標(biāo)準(zhǔn)化工作導(dǎo)則第1部分：標(biāo)準(zhǔn)化文件的結(jié)構(gòu)和起草規(guī)則》的規(guī)

定起草。

本文件等同采用ISO/TS23105：2021《生物技術(shù)生物樣本保藏用于研究和開發(fā)用途的植物生

物樣本保藏要求》，文件類型由ISO的技術(shù)規(guī)范調(diào)整為我國的國家標(biāo)準(zhǔn)化指導(dǎo)性技術(shù)文件。

請(qǐng)注意本文件的某些內(nèi)容可能涉及專利。本文件的發(fā)布機(jī)構(gòu)不承擔(dān)識(shí)別專利的責(zé)任。

本文件由全國生物樣本標(biāo)準(zhǔn)化技術(shù)委員會(huì)（SAC/TC559）提出并歸口。

本文件起草單位：深圳華大生命科學(xué)研究院、上海芯超生物科技有限公司、廣東省中醫(yī)院（廣州中

醫(yī)藥大學(xué)第二附屬醫(yī)院）、中國合格評(píng)定國家認(rèn)可中心、中國食品發(fā)酵工業(yè)研究院有限公司、上海生物

芯片有限公司、中國計(jì)量科學(xué)研究院、首都醫(yī)科大學(xué)附屬北京友誼醫(yī)院、青島華大智造科技有限責(zé)任公

司、中國林業(yè)科學(xué)研究院林業(yè)研究所、中國農(nóng)業(yè)科學(xué)院植物保護(hù)研究所、上海海關(guān)動(dòng)植物與食品檢驗(yàn)檢

疫技術(shù)中心、上海國際旅行衛(wèi)生保健中心（上海海關(guān)口岸門診部）、中國科學(xué)院昆明植物研究所、北京林

業(yè)大學(xué)。

本文件主要起草人：徐訊、郜恒駿、李啟沅、吳靜靜、張小燕、劉亞瓊、陳曲波、李軍燕、張?jiān)?、王曉龍?/p>

危金譜、王博、劉姍姍、王晶、傅博強(qiáng)、張禮生、王萌萌、鄭勇奇、田楨干、張立、張志翔、趙良成、李健、

彭立人、徐燕萍、王然、楊靜、李景文、杜思琦。

Ⅲ

GB/Z44313—2024/ISO/TS23105：2021

引言

植物生物樣本保藏是植物學(xué)及農(nóng)業(yè)生態(tài)系統(tǒng)研究、育新品種和良種研發(fā)培育、確保遺傳多樣性和

保護(hù)種質(zhì)資源的基礎(chǔ)。生物樣本庫的采集和準(zhǔn)入管理對(duì)于優(yōu)化植物遺傳資源具有戰(zhàn)略意義。植物生

物樣本庫以不同的方式獲得樣本，如從田間采集生物樣本、與其他植物生物樣本庫交換、從供體（主要

是研究人員或育種人員）獲得樣本。生物樣本的采集涵蓋多種類型生物樣本，包括冷凍植物組織、液體

保存的植物組織、相關(guān)提取液或其中的一部分。這些采集通常需要專業(yè)的專家來組織和收集，還需要

適當(dāng)?shù)纳飿颖咎幚砗蛢?chǔ)存條件，以保持高質(zhì)量的采集，并最大限度地發(fā)揮優(yōu)秀成果的潛力。本文件

提供了有關(guān)采集、處理、存儲(chǔ)、跟蹤和分發(fā)植物生物樣本的指導(dǎo)。

學(xué)術(shù)機(jī)構(gòu)、非營利性組織和農(nóng)商企業(yè)需要采集、制備、保存、運(yùn)輸和儲(chǔ)存植物生物樣本的標(biāo)準(zhǔn)。本

文件根據(jù)當(dāng)前可用的技術(shù)和科學(xué)知識(shí)，為植物生物樣本庫提供了具體要求、指南和有效實(shí)踐。

Ⅳ

GB/Z44313—2024/ISO/TS23105：2021

生物技術(shù)生物樣本保藏用于研究和

開發(fā)用途的植物生物樣本保藏要求

1范圍

本文件規(guī)定了植物生物樣本及相關(guān)數(shù)據(jù)的采集、制備、保存、運(yùn)輸、儲(chǔ)存、分發(fā)和棄用的要求。

本文件僅適用于能用于進(jìn)一步處理為生物分子（如核酸、蛋白質(zhì)和自身代謝產(chǎn)物）的植物樣本。

本文件適用于所有從事植物生物樣本研究和開發(fā)的組織機(jī)構(gòu)。

2規(guī)范性引用文件

下列文件中的內(nèi)容通過文中的規(guī)范性引用而構(gòu)成本文件必不可少的條款。其中，注

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