標(biāo)準(zhǔn)解讀

《GB/Z 44314-2024 生物技術(shù) 生物樣本保藏 動(dòng)物生物樣本保藏要求》這一標(biāo)準(zhǔn)文件，為動(dòng)物生物樣本的收集、處理、存儲(chǔ)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(dòng)物生物樣本的質(zhì)量與安全性，促進(jìn)科研活動(dòng)中的資源共享與利用效率，同時(shí)保護(hù)生物多樣性與維護(hù)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(dòng)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(duì)生物樣本保藏相關(guān)的專業(yè)術(shù)語進(jìn)行了明確界定，以確保在執(zhí)行標(biāo)準(zhǔn)時(shí)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(shí)間點(diǎn)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(shí)性與代表性。

  4. 質(zhì)量控制：詳細(xì)說明了樣本的質(zhì)量評(píng)估指標(biāo)、檢測(cè)方法及合格標(biāo)準(zhǔn)，包括外觀檢查、生物活性驗(yàn)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(duì)不同類型的動(dòng)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(zhǎng)期穩(wěn)定。

  6. 信息管理：強(qiáng)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(shí)間、處理步驟、保存條件及實(shí)驗(yàn)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(hù)動(dòng)物福利，確保樣本收集基于合法同意，尊重隱私權(quán)與知識(shí)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(dòng)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(gè)行業(yè)的專業(yè)水平。

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


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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文檔簡(jiǎn)介

ICS07.080

CCSC04

中華人民共和國(guó)國(guó)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(dòng)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(shí)施

國(guó)家市場(chǎng)監(jiān)督管理總局

國(guó)家標(biāo)準(zhǔn)化管理委員會(huì)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(yùn)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(chǔ)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(dòng)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(dòng)物的采集方法·····························································13

B.1不同動(dòng)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(dòng)物和小型哺乳動(dòng)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(xiàn)····················································································································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(dòng)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(guó)的國(guó)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(guó)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(guó)科學(xué)院動(dòng)物研究所、上海生物芯片有限公司、中國(guó)合格評(píng)定國(guó)家認(rèn)可中

心、中國(guó)科學(xué)院水生生物研究所、中國(guó)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(jì)醫(yī)院、中國(guó)科學(xué)院昆明動(dòng)物研究所、復(fù)旦大學(xué)、中國(guó)計(jì)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(dòng)植物與食品檢驗(yàn)檢疫技術(shù)中心、上海國(guó)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?jiān)?、康曉楠、尹婷婷、楊亞軍、劉姍姍、王晶、王萌萌、傅博?qiáng)、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(dòng)物生物樣本的生物樣本庫能夠證明其有能力進(jìn)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(dòng)物生物樣本和相關(guān)數(shù)據(jù)。

本文件支持維護(hù)動(dòng)物福祉的過程，因?yàn)樗哺谌齻€(gè)R原則：“替代、減少和改進(jìn)對(duì)動(dòng)物的

使用”[18]。

本文件的使用有助于確保動(dòng)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(dòng)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(dòng)物生物樣本保藏要求

1范圍

本文件規(guī)定了動(dòng)物生物樣本（不包括人類）采集、接收、制備、保存、運(yùn)輸、儲(chǔ)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(jìn)行研究和開發(fā)生物樣本庫的組織機(jī)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(jìn)行的實(shí)驗(yàn)室研

究或以上結(jié)合用途。

本文件不適用于建立源自動(dòng)物生物樣本的細(xì)胞系。

注：國(guó)際、國(guó)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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