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Standard Comparison of Medical equipment between China and Other Countries
Standard Comparison. CCCMHPIE (China Chamber of Commerce for Import and Export of Medicines and Health Products) released Standard Comparison of medical equipment against COVID-19 between China and Other Countries on Mar. 30, 2020.
Please click here to download thsi file.
Medical Masks
| 标准名称 Name of Standards | 标准编号 Code of Standards | 标准名称 Name of Standards | 标准编号 Code of Standards |
| 一次性使用医用口罩 Disposable medical mask | YY/T 0969—2013 | Standard Specification for Performance of Materials Used in Medical Face Masks Respiratory protective devices Medical face masks – Requirements and test methods | ASTM F2100 (US) NIOSH42CFR84(US) EN 14683 :2019(EU) |
| 医用外科口罩 Surgical mask | YY 0469-2011 | ASTM F2100 (US) NIOSH42CFR84(US) EN 14683 :2019(EU) | |
| 医用防护口罩 技术要求 Technical Requirements for Medical Protective Mask | GB 19083-2010 | ASTM F2100 (US) NIOSH42CFR84(US) EN 14683 :2019(EU) |
Protection Gowns
| 标准名称 Name of Standards | 标准编号 Code of Standards | 标准名称 Name of Standards | 标准编号 Code of Standards |
| 医用一次性防护服 技术要求 Technical Requirements for Disposable Medical Protective Clothing | GB 19082-2009 | Standard on Protective Clothing for Emergency Medical Operation | NFPA 1999（US） |
| 医用一次性防护服 技术要求 Technical Requirements for Disposable Medical Protective Clothing | GB 19082-2010 | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities | ANSI_AAMI PB70-2012 （US） |
| 医用一次性防护服 技术要求 Technical Requirements for Disposable Medical Protective Clothing | GB 19082-2011 | Protective clothing -Performance requirements and tests methods for protective clothing against infective agents | EN 14126-2003（EU） |
Thermometer
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| 标准名称 Name of Standards | 标准编号 Code of Standards | 标准名称 Name of Standards | 标准编号 Code of Standards |
| 标准制定中 Standards being formulated | / | Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement | ISO 80601-2-56:2017 (International) |
Test Kits Reagent
| 标准名称 Name of Standards | 标准编号 Code of Standards | 标准名称 Name of Standards | 标准编号 Code of Standards |
| 标准制定中 Standards being formulated | / | 无 | / |
| 标准制定中 Standards being formulated | / | 无 | / |
Ventilators
| 标准名称 Name of Standards | 标准编号 Code of Standards | 标准名称 Name of Standards | 标准编号 Code of Standards |
| 医用电气设备 第 2 部分：呼吸机安全 专用要求 治疗呼吸机 Medical electrical equipment– Part 2: Particular requirements for basic safety of ventilators—- critical care ventilators | GB 9706.28-2006 | Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators | ISO 80601-2-12:2020 （International） EN 60601-2-12:2006 （EU） |
| 高频喷射呼吸机 high-frequency ventilators | YY 0042-2018 | Medical electrical equipment — Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators | ISO/DIS 80601-2-87 （International standards being formulated now） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 1 部分：家用呼吸支 持设备 Ventilators for medical use — Particular requirements for basic safety and essential performance Part 1:Household ventilatory support equipment | YY 0600.1-2007 | Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | ISO 80601-2-79:2018 （International） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 1 部分：家用呼吸支 持设备 Ventilators for medical use— Particular requirements for basic safety and essential performance Part 1: Household ventilatory support equipment | YY 0600.1-2007 | Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency | ISO 80601-2-80:2018 （International） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 1 部分：家用呼吸支 持设备 Ventilators for medical use— Particular requirements for basic safety and essential performance Part 1: Household ventilatory support equipment | YY 0600.1-2008 | Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devices | ISO 10651-6:2009 （International） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 2 部分：依赖呼吸机 患者使用的家用呼吸 机 Ventilators for medical use — Particular requirements for basic safety and essential performance Part 2: Use of household ventilators by ventilator-dependent patients | YY 0600.2-2007 | Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients | ISO 80601-2-72:2015 （International） ISO 10651-2:2009 （International） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 3 部分：急救和转运 用呼吸机 Ventilators for medical use— Particular requirements for basic safety and essential performance Part 3: Emergency and transport ventilators | YY 0600.3-2007 | Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilators | ISO 10651-3:1997 （International） EN 794-3:1998+A2:2009 （EU） |
| 医用呼吸机 基本安全 和主要性能专用 要求 第 4 部分：人工 复苏器 Ventilators for medical use— Particular requirements for basic safety and essential performance Part 4: operator-powered resuscitators | YY 0600.4-2013 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators | ISO 10651-4:2002 （International ） ISO 10651-4:2009 （International） |
| 医用呼吸机 基本安全 和主要性能专用要求 第 5 部分：气动急救复 苏器 Ventilators for medical use — Particular requirements for basic safety and essential performance Part 5: Gas-powered emergency resuscitators | YY 0600.5-2011 | Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitators | ISO 10651-5:2006 （International） |
| 睡眠呼吸暂停治疗 第 1 部分：睡眠呼吸暂停 治疗设备 Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment | YY 0671.1-2009 | Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment | ISO 80601-2-70:2015 （International） |
| 睡眠呼吸暂停治疗 第 1 部分：睡眠呼吸暂停 治疗设备 Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment | YY 0671.1-2010 | Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipment | ISO 17510-1:2009 （International） |
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