ICS 11.040.01 CCS ZMDS C43 中关村医疗器械产业技术创新联盟 团体标准 T/ZMDS 10015—2022 关节手术导航定位系统 第2部分:可用性 Joint surgical navigation and positioning system Part 2: Usability 2022 - 12 - 30发布 2022 - 12 - 30实施 中关村医疗器械产业技术创新联盟 发布 全国团体标准信息平台 T/ZMDS 10015 -2022 目 次 前 言 ................................ ................................ ................................ ................................ ............... 引 言 ................................ ................................ ................................ ................................ ............... 1 适用范围 ................................ ................................ ................................ ................................ .......... 1 2 规范性引用文件 ................................ ................................ ................................ ............................... 1 3 术语和定义 ................................ ................................ ................................ ................................ ....... 1 4 概述 ................................ ................................ ................................ ................................ .................. 4 4.1 参与式设计原则 ................................ ................................ ................................ ....................... 4 4.2 优先考虑的设计原则 ................................ ................................ ................................ ............... 4 4.2.1 确保用户界面 简约 ................................ ................................ ................................ ............ 5 4.2.2 确保设备及时反馈状态 ................................ ................................ ................................ .... 5 4.2.3 确保用户快速排查并及时解决问题 ................................ ................................ ................. 5 4.2.4 确保便捷的操作流程 ................................ ................................ ................................ ........ 5 5 使用错误的风险管理 ................................ ................................ ................................ ....................... 5 5.1 使用错误的类型 ................................ ................................ ................................ ....................... 6 5.2 使用错误的风险管理方法 ................................ ................................ ................................ ........ 6 5.2.1 概述 ................................ ................................ ................................ ................................ .. 6 5.2.2 风险管理 ................................ ................................ ................................ ........................... 6 5.2.3 使用错误的风险管理过程 ................................ ................................ ................................ 6 5.2.4 使用相关风险管理过程的文件 ................................ ................................ ......................... 7 6 用户界面 的可用性规范 ................................ ................................ ................................ .................... 7 6.1 标识、文件和培训材料 ................................ ................................ ................................ ............. 7 6.1.1 概述 ................................ ................................ ................................ ................................ .. 7 6.1.2 基本设计原则 ................................ ................................ ................................ ................... 7 6.1.3 控制使用风险 ................................ ................................ ................................ ................... 8 6.1.4 文档的验证 ................................ ................................ ................................ ....................... 9 6.2 主要操作功能 ................................ ................................ ................................ ........................... 9 6.3 连接 ................................ .......