ICS 03.120.20 A 00 T/CAQI 107 -2020 分析仪器验证与评价通则 General Rule for Verificaiton and Evaluation of Analytical Instrument 2020 - 04 -08发布 2020 - 05 -01实施 中 国 质 量 检 验 协 会 中 国 检 验 检 疫 科 学 研 究 院 联合发布 T/CAQI 中国质量检验协会团体标准 全国团体标准信息平台 T/CAQI 107 —2020 I 目 次 1 范围 ................................ ................................ ................................ ................................ ................................ 2 2 规范性引用文件 ................................ ................................ ................................ ................................ ............ 2 3 术语和定义 ................................ ................................ ................................ ................................ .................... 2 3.1 样机 prototype ................................ ................................ ................................ ................................ ........ 2 3.2 可靠性 reliability ................................ ................................ ................................ ................................ ... 2 3.3 安全性 safety ................................ ................................ ................................ ................................ ......... 3 3.4 环境适应性 environment worthiness ................................ ................................ ................................ ..... 3 3.5 可靠性要求 reliability requirement ................................ ................................ ................................ ....... 3 3.6 验证 verification ................................ ................................ ................................ ................................ .... 3 3.7 评价 evaluation ................................ ................................ ................................ ................................ ....... 3 4 总则 ................................ ................................ ................................ ................................ ................................ 3 4.1 验证与评价准备 ................................ ................................ ................................ ................................ ..... 3 4.2 验证与验评方案 ................................ ................................ ................................ ................................ ..... 4 4.3 验证与评价流程 ................................ ................................ ................................ ................................ ..... 4 5 通用要求 ................................ ................................ ................................ ................................ ........................ 5 5.1 概述 ................................ ................................ ................................ ................................ ......................... 5 5.2 验证要求 ................................ ................................ ................................ ................................ ................. 5 5.2.1 技术指标 验证 ................................ ................................ ................................ ................................ .. 6 5.2.2 安全性验证 ................................ ................................ ................................ ................................ ...... 6 5.2.3 电磁兼容性 验证 ................................ ................................ ................................ .............................. 6 5.2.4 环境适应性 验证 ................................ ................................ ................................ .............................. 6 5.2.5 可靠性验证 ................................ ................................ ................................ ................................ ...... 6 5.3 评价要求 ................................ ................................ ................................ ................................ ................. 6 5.3.1 工作效率评价 ........................