標準解讀

GB/Z 44313-2024是一個中國國家標準指導性技術文件，專注于生物技術領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。該標準詳細規(guī)定了在收集、處理、存儲以及管理植物生物樣本過程中應遵循的一系列技術和質量管理規(guī)范，以確保樣本的質量、穩(wěn)定性和可追溯性，促進生物多樣性的保護和可持續(xù)利用，同時支持科學研究與技術進步。以下是該標準的主要內容概覽：

  1. 范圍與適用對象：明確了標準適用的植物生物樣本類型，包括但不限于種子、孢子、組織、細胞系及DNA等，涵蓋了從野生到栽培的各種植物資源，強調了其對科研與開發(fā)工作的支持作用。

  2. 術語和定義：為確保標準理解的一致性，提供了關鍵術語的明確定義，如生物樣本、保藏、遺傳穩(wěn)定性等。

  3. 樣本采集與預處理：闡述了樣本采集的基本原則，包括采集時間、部位選擇、避免污染的方法等，以及采集后迅速進行的預處理步驟，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. 質量控制：強調了在樣本入庫前需進行嚴格的質量檢查，包括形態(tài)學、生理生化特性及遺傳穩(wěn)定性的評估，并要求建立詳細的樣本信息記錄體系，確保樣本的準確性和可靠性。

  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、種子干燥儲藏等，并詳細說明了相應的環(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：要求建立標準化的樣本管理系統(tǒng)，涵蓋樣本的接收、登記、編碼、存儲位置標記及數(shù)據(jù)庫建設，確保樣本的可追溯性和數(shù)據(jù)共享的便利性。

  7. 設施與設備：描述了保藏設施應滿足的基本條件，包括無菌操作室、低溫儲存設備、監(jiān)控系統(tǒng)等，以及對設施維護和環(huán)境監(jiān)測的要求。

  8. 安全與倫理：強調了在樣本采集、處理、存儲過程中應遵守的相關法律法規(guī)，重視生物安全和遺傳資源的合法利用，保護知識產權和原產地權益。

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


如需獲取更多詳盡信息，請直接參考下方經官方授權發(fā)布的權威標準文檔。

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ICS07.080

CCSC04

中華人民共和國國家標準化指導性技術文件

GB/Z44313—2024/ISO/TS23105：2021

生物技術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實施

國家市場監(jiān)督管理總局

國家標準化管理委員會發(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、試劑和耗材的準備···································································4

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

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

6樣本及相關數(shù)據(jù)的運輸·······························································································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保護液保存樣本··································································································8

8樣本的儲存··············································································································8

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

8.2儲存溫度···········································································································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）常見植物樣本儲存溫度及保存時限··························································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····················································································································16

Ⅰ

GB/Z44313—2024/ISO/TS23105：2021

前言

本文件按照GB/T1.1—2020《標準化工作導則第1部分：標準化文件的結構和起草規(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的技術規(guī)范調整為我國的國家標準化指導性技術文件。

請注意本文件的某些內容可能涉及專利。本文件的發(fā)布機構不承擔識別專利的責任。

本文件由全國生物樣本標準化技術委員會（SAC/TC559）提出并歸口。

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

醫(yī)藥大學第二附屬醫(yī)院）、中國合格評定國家認可中心、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、中國計量科學研究院、首都醫(yī)科大學附屬北京友誼醫(yī)院、青島華大智造科技有限責任公

司、中國林業(yè)科學研究院林業(yè)研究所、中國農業(yè)科學院植物保護研究所、上海海關動植物與食品檢驗檢

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

業(yè)大學。

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、張允、王曉龍、

危金譜、王博、劉姍姍、王晶、傅博強、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及農業(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

保護種質資源的基礎。生物樣本庫的采集和準入管理對于優(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?shù)纳飿颖咎幚砗蛢Υ鏃l件，以保持高質量的采集，并最大限度地發(fā)揮優(yōu)秀成果的潛力。本文件

提供了有關采集、處理、存儲、跟蹤和分發(fā)植物生物樣本的指導。

學術機構、非營利性組織和農商企業(yè)需要采集、制備、保存、運輸和儲存植物生物樣本的標準。本

文件根據(jù)當前可用的技術和科學知識，為植物生物樣本庫提供了具體要求、指南和有效實踐。

Ⅳ

GB/Z44313—2024/ISO/TS23105：2021

生物技術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數(shù)據(jù)的采集、制備、保存、運輸、儲存、分發(fā)和棄用的要求。

本文件僅適用于能用于進一步處理為生物分子（如核酸、蛋白質和自身代謝產物）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)的組織機構。

2規(guī)范性引用文件

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

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