YY/T 1789.2-2021
体外诊断检验系统 性能评价方法 第2部分：正确度
In vitro diagnostic test systems—Performance evaluation method—Part 2:Trueness
2021-12-06
YY/T 1789.5-2023
体外诊断检验系统 性能评价方法 第5部分：分析特异性
In vitro diagnostic test systems—Performance evaluation method—Part 5:Analytical specificity
2023-03-14
YY/T 1789.6-2023
体外诊断检验系统 性能评价方法 第6部分：定性试剂的精密度、诊断灵敏度和特异性
In vitro diagnostic test systems—Performance evaluation method—Part 6:Precision, diagnostic sensitivity and specificity of qualitative reagents
2023-01-13
YY/T 1789.3-2022
体外诊断检验系统 性能评价方法 第3部分：检出限与定量限
In vitro diagnostic test systems—Performance evaluation method—Part 3:Limit of detection and limit of quantitation
2022-07-01
YY/T 1789.4-2022
体外诊断检验系统 性能评价方法 第4部分：线性区间与可报告区间
In vitro diagnostic test systems—Performance evaluation method—Part 4:Linear interval and reportable interval
2022-07-01
YY/T 0688.2-2010
临床实验室检测和体外诊断系统 感染病原体敏感性试验与抗菌剂敏感性试验设备的性能评价 第2部分:抗菌剂敏感性试验设备的性能评价
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices. Part 2:Evaluation of performance of antimicrobial susceptibility devices
2010-12-27
UNE-EN ISO 20776-1-2007
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerob
临床实验室试验和体外诊断试验系统.感染性病原体的敏感性试验和抗菌敏感性试验装置性能的评估.第1部分:抗菌剂对快速生长的aerob的体外活性试验的参考方法
2007-06-27
AS ISO 20776.1-2017
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices, Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aer.
临床实验室试验和体外诊断试验系统.感染性病原体的敏感性试验和抗微生物敏感性试验装置性能的评估 第1部分:抗快速增长的aer的抗微生物制剂体外活性试验的参考方法
2017-02-02
AS ISO 20776.2-2017
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices, Part 2: Evaluation of performance of antimicrobial susceptibility test devices
临床实验室试验和体外诊断试验系统.传染源的敏感性试验和抗生素敏感性试验装置性能的评估 第2部分:抗生素敏感性试验装置性能的评估
2017-02-02
KS P ISO 20776-2
임상검사실 시험 및 체외진단 시험 시스템 — 감염원 감수성 시험 및 항균제 감수성 시험기기 성능 평가 — 제2부: 항균제 감수성 시험기기 성능 평가
临床实验室检测和体外诊断测试系统 - 感染剂的敏感性测试和抗微生物敏感性测试仪器的性能评估 - 第2部分:抗微生物敏感性测试仪器的性能评估
2020-12-30
GOST R ISO 20776-2-2010
Клинические лабораторные исследования и диагностические тест-системы in vitro. Исследование чувствительности инфекционных агентов и оценка функциональных характеристик изделий для исследования чувствительности к антимикробным средствам. Часть 2. Оценка функциональных характеристик изделий для испытания антимикробной чувствительности
临床实验室检测和体外诊断测试系统 感染性试剂的敏感性检测和抗菌药敏试验装置的性能评价 第2部分抗菌药敏试验装置的性能评价
YY/T 1806.1-2021
生物医用材料体外降解性能评价方法 第1部分：可降解聚酯类
Evaluation method for in vitro degradation performance of biomedical materials—Part 1:Degradable polyester
2021-09-06
UNE-EN ISO 20776-2-2008
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices (ISO 20776-2:2007)
临床实验室试验和体外诊断试验系统传染源的敏感性试验和抗生素敏感性试验装置性能的评估第2部分:抗生素敏感性试验装置性能的评估（ISO 20776-2-2007）
2008-01-16
KS P 2224
체외 진단 의료기기 — 자동혈액형판정장치 및 수혈용 혈구응집검사 시약의 분석적 성능평가를 위한 지침
体外诊断医疗器械 专用抗人球蛋白自动血型和抗体测试系统分析性能评价指南
2024-12-23
ISO 20776-2-2021
Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
临床实验室试验和体外诊断试验系统.传染源的敏感性试验和抗生素敏感性试验装置性能的评估.第2部分:抗生素敏感性试验装置对参考肉汤微量稀释的性能评估
2021-12-23
BS EN ISO 20776-2-2021
Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices-Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
临床实验室测试和体外诊断测试系统 传染源的药敏试验和抗菌药敏试验装置的性能评估
2022-01-21
YY/T 1477.1-2016
接触性创面敷料性能评价用标准试验模型 第1部分：评价抗菌活性的体外创面模型
Standard test models for primary wound dressing performance evaluation—Part 1:In vitro wound model for antimicrobial activity evaluation
2016-01-26
YY/T 1465.1-2016
医疗器械免疫原性评价方法 第1部分：体外T淋巴细胞转化试验
Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro
2016-01-26
GB/T 44586.1-2024
体外诊断医疗器械 多重核酸分子检测 第1部分：核酸质量评价术语和通用要求
In vitro diagnostic medical devices—Multiplex molecular testing for nucleic acids—Part 1:Terminology and general requirements for nucleic acid quality evaluation
2024-09-29
KS P ISO 21474-1
체외 진단 의료기기 — 핵산에 대한 다중 분자 시험 — 제1부: 핵산 품질 평가에 대한 용어 및 일반 요구사항
体外诊断医疗器械核酸多重分子检测第1部分:核酸质量评价术语和一般要求
2023-12-28