DB43/T 959.5-2023 异种移植用无指定病原体（DesignatedPathogen Free, DPF）医用供体猪 第5部分：环境与设施

ICS70.080

CCSB44

43

湖南省地方标准

DB43/T959.5—2023

代替DB43/T95.95—2014

异种移植用无指定病原体（Designated

PathogenFree,DPF）医用供体猪

第5部分：环境与设施

MedicalgradeDPFdonorpigforxenotransplantation

Part5:Requirementsofenvironmentandhousingfacilities

2023-11-09发布2024-02-09实施

湖南省市场监督管理局发布

DB43/T959.5—2023

目次

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

引言························································································································Ⅴ

1范围·····················································································································1

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

3术语和定义············································································································1

4建筑·····················································································································2

5工艺布局···············································································································3

6环境·····················································································································4

7饲养条件···············································································································5

8废物处理···············································································································6

9运输·····················································································································6

10检测····················································································································7

I

DB43/T959.5—2023

II

DB43/T959.5—2023

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分：标准化文件的结构和起草规则》的规

定起草。

本文件是DB43/T959《异种移植用无指定病原体（DesignatedPathogenFree,DPF）医用供体猪》

的第5部分。DB43/T959已发布了以下部分：

——第1部分：遗传质量控制；

——第2部分：微生物、寄生虫学等级与监测；

——第3部分：配合饲料；

——第4部分：病理学诊断规范；

——第5部分：环境与设施。

本文件替代DB43/T959.5—2014《异种移植用无指定病原体（DesignatedPathogenFree,DPF）

医用供体猪第5部分：环境与设施》，与DB43/T959.5—2014相比，除结构调整和编辑性改动外，主

要技术变化如下：

a）增加了“引言”一章；

b）增加了垫料相关内容（见4.2.6）；

c）增加了“辅助区”（见5.1.4）；

d）删除了“感染性、放射性废物处理”（见2014版的8.3）。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由湖南省科学技术厅提出并归口。

本文件起草单位：中南大学湘雅三医院，湖南赛诺生物科技股份有限公司。

本文件主要起草人：王维、刘建高、胡鹏志、马小倩、李桑、徐畅、王佳、石兴勇。

本文件及其所替代文件的历次版本发布情况为：

——2014年首次发布为DB43/T959.5—2014；

——本次为第一次修订。

III

DB43/T959.5—2023

IV

DB43/T959.5—2023

引言

异种移植用无指定病原体（DesignatedPathogenFree,DPF）医用供体猪标准化能更好的促进异

种细胞、组织和器官移植相关产业发展，有利于湖南省政府部门行政审批和监管工作的实施。为了保证

异种移植用无指定病原体医用供体猪研发、生产和应用的稳定、高效进行，对其进行标准化管理已成为

首要任务。在这方面，湖南省已建立了异种移植用无指定病原体医用供体猪基础性地方标准体系。在该

体系中，DB43/T959《异种移植用无指定病原体（DesignatedPathogenFree,DPF）医用供体猪》是

指导湖南省异种移植用无指定病原体医用供体猪培育的基础性和通用性的标准。DB43/T959旨在确立

普遍适用于标准化异种移植用无指定病原体医用供体猪遗传质量控制、微生物检测、饲料、病理学检测、

环境设施的准则，拟由五个部分构成。

——第1部分：遗传质量控制。目的在于维持异种移植用无指定病原体医用供体猪遗传质量稳定性。

——第2部分：微生物、寄生虫学等级与监测。目的在于保证异种移植用无指定病原体医用供体猪

生物安全性。

——第3部分：配合饲料。目的在于保障异种移植用无指定病原体医用供体猪饲料的安全和营养。

——第4部分：病理学诊断规范。目的在于标准化异种移植用无指定病原体医用供体猪病理学检测

内容和方法。

——第5部分：环境与设施。目的在于标准化异种移植用无指定病原体医用供体猪环境条件控制和

设施建设。

环境与设施标准化是为异种移植用无指定病原体医用供体猪建立稳定且安全舒适的屏障环境。为了

做好这项工作，湖南省在2014年发布了有关异种移植用无指定病原体医用供体猪环境与设施的地方标

准。DB43/T959.5发布实施已九年，这期间异种移植相关技术不断更新，供体猪培育环境与设施受到

越来越广泛的重视。首先，国际异种移植用无指定病原体医用供体猪培育的环境与设施不断完善。其次，

随着WHO更新国际异种移植规范——《2018长沙宣言》以及DB43/T959.5的应用和实践，产生了新的

需求与建议。鉴于此，确有必要修订完善DB43/T959