標(biāo)準(zhǔn)解讀

《GB/Z 44314-2024 生物技術(shù) 生物樣本保藏 動物生物樣本保藏要求》這一標(biāo)準(zhǔn)文件，為動物生物樣本的收集、處理、存儲及管理提供了一套詳細(xì)的規(guī)范和指導(dǎo)原則。該標(biāo)準(zhǔn)旨在確保動物生物樣本的質(zhì)量與安全性，促進科研活動中的資源共享與利用效率，同時保護生物多樣性與維護倫理道德。以下是該標(biāo)準(zhǔn)的主要內(nèi)容概覽：

  1. 范圍界定：明確了標(biāo)準(zhǔn)適用的動物生物樣本類型，包括但不限于血液、組織、細(xì)胞、DNA/RNA、微生物等，以及這些樣本在基礎(chǔ)研究、醫(yī)學(xué)研究、生物技術(shù)開發(fā)等領(lǐng)域的應(yīng)用范疇。

  2. 術(shù)語定義：對生物樣本保藏相關(guān)的專業(yè)術(shù)語進行了明確界定，以確保在執(zhí)行標(biāo)準(zhǔn)時各方理解一致。

  3. 樣本采集與預(yù)處理：規(guī)定了樣本采集前的準(zhǔn)備工作、采集方法、時間點選擇、以及采集后的立即處理步驟（如抗凝、固定、冷凍等），以減少樣本降解，保證樣本的真實性與代表性。

  4. 質(zhì)量控制：詳細(xì)說明了樣本的質(zhì)量評估指標(biāo)、檢測方法及合格標(biāo)準(zhǔn)，包括外觀檢查、生物活性驗證、遺傳物質(zhì)完整性分析等，確保入庫樣本滿足研究需求。

  5. 保存條件與方法：針對不同類型的動物生物樣本，規(guī)定了適宜的保存條件（如溫度、濕度、光照等）和保存方法（如冷凍、液氮保存、干燥等），以維持樣本長期穩(wěn)定。

  6. 信息管理：強調(diào)了樣本相關(guān)信息記錄的重要性，包括但不限于樣本來源、采集時間、處理步驟、保存條件及實驗數(shù)據(jù)等，要求建立完善的樣本信息管理系統(tǒng)，便于追蹤與共享。

  7. 倫理與法律遵循：重申在樣本采集、使用、分享過程中必須遵守的相關(guān)法律法規(guī)及倫理準(zhǔn)則，保護動物福利，確保樣本收集基于合法同意，尊重隱私權(quán)與知識產(chǎn)權(quán)。

  8. 設(shè)施與安全：規(guī)定了樣本庫應(yīng)具備的基本設(shè)施條件、操作流程安全措施及應(yīng)急處理方案，確保人員安全與環(huán)境控制，防止樣本污染與損失。

  9. 培訓(xùn)與資質(zhì)：提出了從事動物生物樣本保藏工作的人員應(yīng)接受的專業(yè)培訓(xùn)要求及資質(zhì)認(rèn)證標(biāo)準(zhǔn)，以提升整個行業(yè)的專業(yè)水平。

  10. 監(jiān)督與評估：建議定期對生物樣本保藏工作進行內(nèi)部審查與外部評估，持續(xù)改進管理體系，確保標(biāo)準(zhǔn)得到有效實施。


如需獲取更多詳盡信息，請直接參考下方經(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/Z44314—2024/ISO/TS20388：2021

生物技術(shù)生物樣本保藏

動物生物樣本保藏要求

Biotechnology—Biobanking—

Requirementsforthebiobankingofanimalbiologicalmaterial

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

animalbiologicalmaterial，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(biāo)準(zhǔn)化管理委員會發(fā)布

GB/Z44314—2024/ISO/TS20388:2021

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

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

4.2倫理要求···········································································································3

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

5生物樣本的采集········································································································4

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

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

6生物樣本及相關(guān)數(shù)據(jù)的運輸·························································································8

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

8生物樣本的制備和保存·······························································································9

9生物樣本的儲存······································································································10

10生物樣本的分發(fā)、銷毀及棄用····················································································10

10.1分發(fā)··············································································································10

10.2銷毀和棄用·····································································································10

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

附錄A（資料性）動物生物樣本數(shù)據(jù)采集表（示例）·····························································11

附錄B（資料性）不同性質(zhì)和體型動物的采集方法·····························································13

B.1不同動物保定方法·····························································································13

B.2固體組織樣本采集示例·······················································································13

B.3血液樣本采集方法示例·······················································································13

B.4尿液樣本采集方法示例·······················································································14

B.5反芻動物和小型哺乳動物乳樣采集方法示例····························································14

B.6其他樣本采集方法示例·······················································································15

附錄C（資料性）生物樣本轉(zhuǎn)移協(xié)議或其他等效文件信息····················································16

附錄D（規(guī)范性）生物樣本采集、制備和保存方法·······························································17

參考文獻····················································································································19

Ⅰ

GB/Z44314—2024/ISO/TS20388:2021

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/TS20388：2021《生物技術(shù)生物樣本保藏動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)布機構(gòu)不承擔(dān)識別專利的責(zé)任。

本文件由全國生物樣本標(biāo)準(zhǔn)化技術(shù)委員會（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）、中國科學(xué)院動物研究所、上海生物芯片有限公司、中國合格評定國家認(rèn)可中

心、中國科學(xué)院水生生物研究所、中國食品發(fā)酵工業(yè)研究院有限公司、首都醫(yī)科大學(xué)附屬北京友誼醫(yī)

院、上海交通大學(xué)醫(yī)學(xué)院附屬仁濟醫(yī)院、中國科學(xué)院昆明動物研究所、復(fù)旦大學(xué)、中國計量科學(xué)研究院、

青島華大智造科技有限責(zé)任公司、上海海關(guān)動植物與食品檢驗檢疫技術(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）、北京市畜牧總站、北京林業(yè)大學(xué)、復(fù)旦大學(xué)附屬中山醫(yī)院。

本文件主要起草人：徐訊、李啟沅、郜恒駿、吳靜靜、張小燕、王桃、陳曲波、郝捷、趙同標(biāo)、李軍燕、

王曉龍、危金譜、潘魯湲、王博、張允、康曉楠、尹婷婷、楊亞軍、劉姍姍、王晶、王萌萌、傅博強、田楨干、

陸曄、楊宇澤、張立、喬格俠、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議，以使處理動物生物樣本的生物樣本庫能夠證明其有能力進行樣本庫的

操作，并有能力為研究和開發(fā)提供適當(dāng)質(zhì)量的動物生物樣本和相關(guān)數(shù)據(jù)。

本文件支持維護動物福祉的過程，因為它植根于三個R原則：“替代、減少和改進對動物的

使用”[18]。

本文件的使用有助于確保動物生物樣本的質(zhì)量和在ISO20387應(yīng)用下研究結(jié)果的可靠性。

本文件中可以使用以下能愿動詞：

——“應(yīng)”表示要求；

——“宜”表示建議；

——“可”表示允許；

——“能”表示一種可能性或能力。

Ⅳ

GB/Z44314—2024/ISO/TS20388:2021

生物技術(shù)生物樣本保藏

動物生物樣本保藏要求

1范圍

本文件規(guī)定了動物生物樣本（不包括人類）采集、接收、制備、保存、運輸、儲存、分發(fā)、銷毀和棄用的

要求。此類資源包括固體組織樣本、液體和相關(guān)細(xì)胞、排泄物及相關(guān)數(shù)據(jù)。

本文件適用于研發(fā)用生物樣本或/和相關(guān)數(shù)據(jù)，并適用于從生物樣本中獲取的生物分子，如核酸、

蛋白質(zhì)和代謝物。

本文件適用于所有進行研究和開發(fā)生物樣本庫的組織機構(gòu)。

本文件不適用于用于食品或飼料生產(chǎn)的生物樣本、為食品或飼料生產(chǎn)或治療用途進行的實驗室研

究或以上結(jié)合用途。

本文件不適用于建立源自動物生物樣本的細(xì)胞系。

注：國際、國內(nèi)和地區(qū)的法規(guī)或要求也適用于本文件中的特定條款。

2規(guī)范性引用文件

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