T/CPASE G 035—2024 I 目 次 前言 ······························································ ······························································ III 引言 ······························································ ······························································ IV 1 范 围 ······························································ ···························································· 1 2 规范性引用文件 ······························································ ············································ 1 3 术语和定义 ······························································ ··················································· 1 4 总则 ······························································ ···························································· 3 5 设备管理 ······························································ ······················································ 6 6 与设备相关的外部环境 ······························································ ··································· 9 7 安全标志 ······························································ ······················································ 9 8 合格供方的评价 ······························································ ·········································· 10 9 安全与节能技术档案 ······························································ ···································· 10 10 故障及事故与应急管理 ······························································ ································ 11 11 双重预防机制 ······························································ ············································ 12 附录 A（资料性） 医疗机构合规管理涉及的特种设备清单 ···················································· 14 附录 B（资料性） 医疗机构合规管理涉及的特种设备主要法律、法规、安全技术规范和标准 ······· 15 附录 C（资料性） 医疗机构特种设备使用合规管理检查表 ···················································· 18 附录 D（资料性） 医疗机构特种设备安全管理分级评价办法 ················································· 21 附录 E（资料性） 医疗机构特种设备自行检查示例表单样例 ················································· 26 附录 F（资料性） 医用氧气供应源控制要求 ······························································ ········ 34 附录 G（资料性） 医用氧舱呼吸气系统操作控制要求 ·························································· 36 附录 H（资料性） 医疗机构特种设备合格供方评价办法 ······················································ 38 附录 J（资料性） 医用氧舱应急处置措施 ······························································ ··········· 40 编制说明 ······························································ ························································ 43 全国团体标准信息平台 全国团体标准信息平台 T/CPASE G 035—2024 III 前 言 本文件按照 GB/T 1.1 —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。 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。 本文件由中国特种设备安全与节能促进会提出并归口。 本文件起草单位：国家市场监督管理总局特种设备安全监察局、烟台宏远氧业股份有限公 司、海南省锅炉压力容器与特种设备检验所、山西省检验检测中心（山西省标准计量技术研究 院）、烟台豪特氧业设备有限公司、贵州风雷航空军械有限责任公司、潍坊华信氧业有限公司、中国人民解放军联勤保障部队第九六 〇医院、中国舰船研究设计中心、上海市特种设备监督检验 技术研究院、安泰源特种设备检测集团有限公司、北京医学会、北京朝阳医院、深圳市人民医 院、解放军总医院第六医学中心、大有科技集团有限公司。 本文件主要起草人：史进、常彦衍、张建荣、袁素霞、刘建、林彦群、常健、王有存、薛小龙、 王智胜、温建平、石锡军、王志强、龙颖、潘树义、张晓锋、来兴胜、云晗、容志斌、相福海、邴占香、 谢鹏、龙家益、李国庆、杨友波、刘颖、蒋忻芮。 本文件为首次发布。 全国团体标准信息平台 T/CPASE G 035—2024 IV 引 言 本文件依据《中华人民共和国特种设备安全法》、国务院令第 739号《 医疗器械监督管理条 例》、国家市场监督管理总局令第 74号《特种设备使用单位落实使用安全主体责任监督管理规 定》、国家市场监督管理总局令第 57号《特种设备安全监督检查办法》和 GB/T 35770 —2022 《合 规管理体系 要求及使用指南》的精神制定，旨在规范和推广医疗机构特种设备使用的合规性管 理，提高医疗机构特种设备使用的安全水平。 本文件规定了对医疗机构特种设备的相关人员、管理制度 、设备管理、外部环境、合格供方 的评价、应急管理、双重预防机制等方面的合规管理内容及要求。 本文件由中国特种设备安全与节能促进会（以下简称中特 促进会）负责解释，对于未经中特 促进会书面授权或认可的其他机构对标准的宣贯或解释所产生的理解歧义和由此产生的任何后 果，以及本文件使用方对于因本文件使用不当所产生的任何纠纷和损失，中特促进会将不承担任何责任。 全国团体标准信息平台