標準解讀

《GB/Z 44314-2024 生物技術 生物樣本保藏 動物生物樣本保藏要求》這一標準文件，為動物生物樣本的收集、處理、存儲及管理提供了一套詳細的規范和指導原則。該標準旨在確保動物生物樣本的質量與安全性，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。以下是該標準的主要內容概覽：

  1. 范圍界定：明確了標準適用的動物生物樣本類型，包括但不限于血液、組織、細胞、DNA/RNA、微生物等，以及這些樣本在基礎研究、醫學研究、生物技術開發等領域的應用范疇。

  2. 術語定義：對生物樣本保藏相關的專業術語進行了明確界定，以確保在執行標準時各方理解一致。

  3. 樣本采集與預處理：規定了樣本采集前的準備工作、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. 質量控制：詳細說明了樣本的質量評估指標、檢測方法及合格標準，包括外觀檢查、生物活性驗證、遺傳物質完整性分析等，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），以維持樣本長期穩定。

  6. 信息管理：強調了樣本相關信息記錄的重要性，包括但不限于樣本來源、采集時間、處理步驟、保存條件及實驗數據等，要求建立完善的樣本信息管理系統，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法律法規及倫理準則，保護動物福利，確保樣本收集基于合法同意，尊重隱私權與知識產權。

  8. 設施與安全：規定了樣本庫應具備的基本設施條件、操作流程安全措施及應急處理方案，確保人員安全與環境控制，防止樣本污染與損失。

  9. 培訓與資質：提出了從事動物生物樣本保藏工作的人員應接受的專業培訓要求及資質認證標準，以提升整個行業的專業水平。

  10. 監督與評估：建議定期對生物樣本保藏工作進行內部審查與外部評估，持續改進管理體系，確保標準得到有效實施。


如需獲取更多詳盡信息，請直接參考下方經官方授權發布的權威標準文檔。

....

查看全部

  • 現行
  • 正在執行有效
  • 2024-08-23 頒布
  • 2024-08-23 實施
?正版授權
GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求_第1頁
GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求_第2頁
GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求_第3頁
GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求_第4頁
GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求_第5頁
免費預覽已結束，剩余23頁可下載查看

下載本文檔

GB/Z 44314-2024生物技術生物樣本保藏動物生物樣本保藏要求-免費下載試讀頁

文檔簡介

ICS07.080

CCSC04

中華人民共和國國家標準化指導性技術文件

GB/Z44314—2024/ISO/TS20388：2021

生物技術生物樣本保藏

動物生物樣本保藏要求

Biotechnology—Biobanking—

Requirementsforthebiobankingofanimalbiologicalmaterial

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

animalbiologicalmaterial，IDT）

2024?08?23發布2024?08?23實施

國家市場監督管理總局

國家標準化管理委員會發布

GB/Z44314—2024/ISO/TS20388:2021

目次

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

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

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

2規范性引用文件········································································································1

3術語和定義··············································································································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生物樣本及相關數據的運輸·························································································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、銷毀及棄用····················································································10

10.1分發··············································································································10

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

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

附錄A（資料性）動物生物樣本數據采集表（示例）·····························································11

附錄B（資料性）不同性質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）生物樣本轉移協議或其他等效文件信息····················································16

附錄D（規范性）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《標準化工作導則第1部分：標準化文件的結構和起草規則》的規

定起草。

本文件等同采用ISO/TS20388：2021《生物技術生物樣本保藏動物生物樣本保藏要求》，文件

類型由ISO的技術規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、廣東省中醫院（廣州中

醫藥大學第二附屬醫院）、中國科學院動物研究所、上海生物芯片有限公司、中國合格評定國家認可中

心、中國科學院水生生物研究所、中國食品發酵工業研究院有限公司、首都醫科大學附屬北京友誼醫

院、上海交通大學醫學院附屬仁濟醫院、中國科學院昆明動物研究所、復旦大學、中國計量科學研究院、

青島華大智造科技有限責任公司、上海海關動植物與食品檢驗檢疫技術中心、上海國際旅行衛生保健

中心（上海海關口岸門診部）、北京市畜牧總站、北京林業大學、復旦大學附屬中山醫院。

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、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提供適當質量的動物生物樣本和相關數據。

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量和在ISO20387應用下研究結果的可靠性。

本文件中可以使用以下能愿動詞：

——“應”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

生物技術生物樣本保藏

動物生物樣本保藏要求

1范圍

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

要求。此類資源包括固體組織樣本、液體和相關細胞、排泄物及相關數據。

本文件適用于研發用生物樣本或/和相關數據，并適用于從生物樣本中獲取的生物分子，如核酸、

蛋白質和代謝物。

本文件適用于所有進行研究和開發生物樣本庫的組織機構。

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

究或以上結合用途。

本文件不適用于建立源自動物生物樣本的細胞系。

注：國際、國內和地區的法規或要求也適用于本文件中的特定條款。

2規范性引用文件

溫馨提示

  • 1. 本站所提供的標準文本僅供個人學習、研究之用，未經授權，嚴禁復制、發行、匯編、翻譯或網絡傳播等，侵權必究。
  • 2. 本站所提供的標準均為PDF格式電子版文本（可閱讀打印），因數字商品的特殊性，一經售出，不提供退換貨服務。
  • 3. 標準文檔要求電子版與印刷版保持一致，所以下載的文檔中可能包含空白頁，非文檔質量問題。

評論

0/150

提交評論