DB43/T 958.5-2023 实验用小型猪 第5部分：环境与设施

ICS70.080

CCSB44

43

湖南省地方标准

DB43/T958.5—2023

代替DB43/T958.5—2014

实验用小型猪

第5部分：环境与设施

Experimentalminipig

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/T958.5—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···············································································································2

6环境·····················································································································3

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

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

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

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

I

DB43/T958.5—2023

II

DB43/T958.5—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/T958《实验用小型猪》的第5部分。DB43/T958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/T958.5—2014《实验用小型猪第5部分：环境与设施》，与DB43/T958.5—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）增加了治疗室（见5.1.2）；

c）增加了“辅助区”（见5.1.4）；

d）删除了“表1实验用小型猪的环境分类”中清洁级（见6.1，2014版的6.1）；

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/T958.5—2014；

——本次为第一次修订。

III

DB43/T958.5—2023

IV

DB43/T958.5—2023

引言

实验用小型猪标准化能更好的促进器官移植、人工智能医疗器械等生物医药研发领域和相关产业发

展，为湖南省生物医药领域科学研究、产品效验、鉴定测试等活动开展提供质量保证，有利于湖南省政

府部门行政审批和监管工作的实施。为了保证实验用小型猪研发、生产和应用的稳定、高效进行，对实

验用小型猪进行标准化管理已成为首要任务。在这方面，湖南省已建立了实验用小型猪基础性地方标准

体系。在该体系中，DB43/T958《实验用小型猪》是指导湖南省实验用小型猪培育的基础性和通用性的

标准。DB43/T958旨在确立普遍适用于标准化实验用小型猪遗传质量控制、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。目的在于维持实验用小型猪的遗传质量稳定性。

——第2部分：微生物、寄生虫学等级与监测。目的在于保证实验用小型猪的生物安全性。

——第3部分：配合饲料。目的在于保障实验用小型猪饲料的安全和营养。

——第4部分：病理学诊断规范。目的在于标准化实验用小型猪病理学检测内容和方法。

——第5部分：环境与设施。目的在于标准化不同等级实验用小型猪环境条件控制和设施建设。

环境与设施标准化是为实验用小型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年发布了有关实验用小型猪环境与设施的地方标准。DB43/T958.5发布实施已九年，这期间实

验用小型猪培育技术不断更新，实验用小型猪培育环境与设施受到越来越广泛的重视。国家标准已删除

了实验用小型猪清洁级等级，其培养环境与设施也因此随之变化。鉴于此，确有必要修订完善D