September 26, 2021

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Standard Comparison

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 maskYY/T 0969—2013Standard 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 MaskGB 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 19082-2009Standard on Protective Clothing for Emergency Medical OperationNFPA 1999(US)
医用一次性防护服 技术要求 Technical
Requirements for Disposable Medical Protective Clothing
GB 19082-2010Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilitiesANSI_AAMI PB70-2012
(US)
医用一次性防护服 技术要求 Technical
Requirements for Disposable Medical Protective Clothing
GB 19082-2011Protective clothing -Performance requirements and tests methods for protective clothing against infective agentsEN 14126-2003(EU)

Thermometer

Microsoft Word – 修改格式).doc

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//
标准制定中 Standards being formulated//

Ventilators

PPE Standard Comparison

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 9706.28-2006Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilatorsISO 80601-2-12:2020
(International)
EN 60601-2-12:2006
(EU)
高频喷射呼吸机 high-frequency ventilatorsYY 0042-2018Medical 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 0600.1-2007Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairmentISO 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 0600.1-2007Medical electrical equipment — Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiencyISO 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 0600.1-2008Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 6: Home-care ventilatory support devicesISO 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 0600.2-2007Medical electrical equipment — Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patientsISO 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 0600.3-2007Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilatorsISO 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 0600.4-2013Lung ventilators — Part 4: Particular requirements for operator-powered resuscitatorsISO 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 0600.5-2011Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitatorsISO 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 0671.1-2009Medical electrical equipment — Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipmentISO 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 0671.1-2010Sleep apnoea breathing therapy — Part 1: Sleep apnoea breathing therapy equipmentISO 17510-1:2009
(International)

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