检测项目（部分）
环境要求
电外科干扰的恢复
袖带压力显示误差范围
气囊和袖带的要求
全部参数
带包装血压计振动与跌落
试验条件
电磁干扰-要求和测试方法
安全
电气安全
设备标识
元器件和组件
充气源
对袖带的要求
静压系统
寿命
电磁兼容性
振动试验
量程
系统漏气
袖带
带气囊的袖带
控制器和仪表的准确性和危险输出的防护
超温
ME设备的识别、标记和文件
最大充气时间
报警
标识要求
工作条件
单位
分辨率
袖套压力稳定性
全部项目
供电电源的中断
环境试验
ME设备的结构
不带包装血压计跌落
自动气阀
最大袖带压
危害处境及故障状态
检测样品（部分）
无创自动测量血压计
非侵入式血压计
无创血压计 - 电-机血压测量系统
无创电子血压计
无创自动血压计
血压计和血压表
无创血压计
检测标准（部分）
国家标准 GB 3053-1993 血压计和血压表
【适用范围】本标准规定了血压计、血压表的产品分类、技术要求、试验方法、验收规则及标志、包装、运输、贮存等要求。 本标准适用于汞柱式血压计和机械弹性元件式血压表；不适用于电子血压计。该产品供测量人体血压用。
【中国标准分类】 C38 医药器械
【国际标准分类】 71.060.20-氧化物
国家标准 GB 8049-1987 台式血压计检验规则
【适用范围】
【中国标准分类】 A53 医药器械
【国际标准分类】 17.100-力、重力和压力的测量
国家级标准 JJG 270-2008 血压计和血压表检定规程
【适用范围】本规程适用于各种校表仪的首次检定、后续检定及使用中检验。
【中国标准分类】 A53 计量
【国际标准分类】 17.100-力、重力和压力的测量
国家级标准 JJG 270-1995 血压计和血压表检定规程
【适用范围】
【中国标准分类】 A53 计量
【国际标准分类】 17.100-力、重力和压力的测量
国家级标准 JJG 692-1999 数字式电子血压计（静态）检定规程
【适用范围】
【中国标准分类】 G44 计量
【国际标准分类】 83.140.99-其他橡胶和塑料制品
行业标准 YY 0670-2008 无创自动测量血压计
【适用范围】本标准规定了所有使用阻塞袖带对人体进行间接动脉血压测量的自动的、电子的动脉血压计的安全性和有效性的要求。本标准适用于利用示波法或类似的其他方法来完成无创血压测量的电子血压计或具有这个功能的其他设备。包括所有通过袖带充气、放气，并借助于所产生的震动、流动、声音来测量、显示、记录血压的仪器。本标准涵盖了所有从新生儿到成人的各年龄段的血压测量设备。本标准也适用于动态血压监测仪。此类设备患者可随身佩戴或携带，可以在日常活动或起居过程中反复测量血压和心率，并保存获得的结果。注意：附录A中包含了关于91
HG/T 2458
中华人民共和国食品卫生法（1995年）
【中国标准分类】 C30 医药器械
【国际标准分类】 11.040.30-外科器械和材料
行业标准 YY 9706.230-2023 血压计
【适用范围】本标准适用于血压计。
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.50-射线照相设备
地方标准 CNS 13075-2007 非侵入式电子血压计
【适用范围】本标准规范使用充气式压脉带作非侵入式动脉血压量测的电子或自动血压计(以下简称血压计)和其配件的一般、性能、效益、机械和电性安全规定，包括型式认证之测试方法压脉带。本标准仅适用于量测上臂、手腕或大腿之器材。
【中国标准分类】 C30 医药器械
【国际标准分类】 11.040.01-医疗设备综合
地方标准 CNS 15041-1-2007 医用电气设备--第2-30部分：自动无创伤性血压计的基本安全和基本性能的专用要求
【适用范围】本标准适用于品项管理之RFID系统信息交换的数据协议是规定在CNS 15322及本标准里。完全地了解整个数据协议需要此两部标准；但是每一个标准都有其专注的特定接口：? CNS 15322提出应用系统的接口 ? 本标准处理送往无线射频卷标的数据与其表现层的过程，以及所撷取来自无线射频卷标的数据的起始过程。本标准专注于转送语法的编码，就如同定义于CNS 15322标准的应用命令。在逻辑内存内的编码软件，类似于被询答器寻址的无线射频标签物理内存。 本标准? 定义对象识别码的编码结构；? 规定适用于编码数据的
【中国标准分类】 C39 医药器械
【国际标准分类】 11.040-医疗设备
国际标准 IEC 80601-2-30-2009 医用电气设备--第2-30部分：自动无创伤性血压计的基本安全和基本性能的专用要求
【适用范围】This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofAUTOMATED SPHYGMOMANOMETERS
hereafter referred to as ME EQUIPMENT
which by means ofan inflatable CUFF
are used for intermittent non-continuous indirect measurement of theBLOOD PRESSURE without arterial puncture.NOTE 1 Equipment that performs indirect measurement of the BLOOD PRESSURE without arterial puncture does notdirectly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE forthis ME EQUIPMENT and its ACCESSORIES
including the requirements for the accuracy of aDETERMINATION.This standard covers electrically-powered intermittent
indirect measurement of the BLOODPRESSURE without arterial puncture
ME EQUIPMENT with automatic methods for estimatingBLOOD PRESSURE
including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.Requirements for indirect measurement of the BLOOD PRESSURE without arterial punctureME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used inconjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE(NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only
or toME SYSTEMS only
the title and content of that clause or subclause will say so. If that is not thecase
the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS
as relevant.HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMSwithin the scope of this standard are not covered by specific requirements in this standardexcept in 201.11 and 201.105.3.3
as well as 7.2.13 and 8.4.1 of IEC 60601-1.NOTE 2 See also 4.2 of the general standard.
【中国标准分类】 C39 医药器械
【国际标准分类】 11.040-医疗设备
国际标准 IEC 80601-2-30-2018 医用电气设备--第2-30部分：自动无创伤性血压计的基本安全和基本性能的专用要求
【适用范围】This part of the 80601 International Standard applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS hereafter referred to as ME EQUIPMENT
which by means of an inflatable CUFF are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for
this ME EQUIPMENT and its ACCESSORIES including the requirements for the accuracy of a
DETERMINATION.
This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent
indirect estimation of the BLOOD PRESSURE without arterial puncture including BLOOD
PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture
ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in
conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE
(NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only the title and content of that clause or subclause will say so. If that is not the case the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 201.11 and 201.105.3.3 as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS hereafter referred to as ME EQUIPMENT
which by means of an inflatable CUFF are used for non-continuous indirect estimation of the BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This document specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for
this ME EQUIPMENT and its ACCESSORIES including the requirements for the accuracy of a
DETERMINATION.
This document covers automatic electrically-powered ME EQUIPMENT used for the intermittent
indirect estimation of the BLOOD PRESSURE without arterial puncture including BLOOD
PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect estimation of the BLOOD PRESSURE without arterial puncture
ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in
conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE
(NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only the title and content of that clause or subclause will say so. If that is not the case the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document
except in 201.11 and 201.105.3.3 as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.
NOTE 2 See also 4.2 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.
【中国标准分类】 C39 医药器械
【国际标准分类】 11.040.01-医疗设备综合
国际标准 ISO 81060-1-2007 无创伤性血压计--第1部分：非自动化测量型的要求和试验方法
【适用范围】This part of ISO 81060 specifies requirements for non-automated sphygmomanometers
as defined in 3.11
and their accessories
which
by means of inflatable cuffs
are used for the non-invasive blood pressuremeasurement by operator observation.This part of ISO 81060 specifies requirements for the safety and essential performance
includingeffectiveness and labelling
for non-automated sphygmomanometers and their accessories
including testmethods to determine the accuracy of non-invasive blood pressure measurement.The part of ISO 81060 covers non-invasive blood pressure measurement devices with a pressure-sensingelement and display used in conjunction with means of detecting blood flow.EXAMPLE 1 A stethoscope for detecting Korotkoff sounds
Doppler ultrasound or other manual methods.Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressuresensing elements and/or displays used in conjunction with other automatic methods determining bloodpressure are specified in IEC 60601-2-30 [7].Requirements for invasive blood pressure measurement equipment that directly measure blood pressure arespecified in document IEC 60601-2-34 [8].EXAMPLE 2 Measuring equipment
including associated transducers
that is used for the invasive measurement ofcirculatory system pressures.
【中国标准分类】 C46 医药器械
【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备
国际标准 ISO 81060-2-2013 无创血压计--第2部分：自动测量型的临床研究
【适用范围】This part of ISO 81060 specifies the requirements and methods for the CLINICAL INVESTIGATION of 61 ME EQUIPMENT used for the intermittent non-invasive automated estimation of the arterial BLOOD PRESSURE by utilizing a CUFF. This part of ISO 81060 is applicable to all SPHYGMOMANOMETERS that sense or display pulsations
flow or sounds for the estimation
display or recording of BLOOD PRESSURE. These SPHYGMOMANOMETERS need not have automatic CUFF inflation.This part of ISO 81060 covers SPHYGMOMANOMETERS intended for use in all PATIENT populations (e.g. all age and weight ranges)
and all conditions of use (e.g. ambulatory BLOOD PRESSURE monitoring
stress testing BLOOD PRESSURE monitoring and BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT for self-measurement as well as use in a professional healthcare facility).EXAMPLE AUTOMATED SPHYGMOMANOMETER as given in IEC 80601-2-30 undergoing CLINICAL INVESTIGATION according to this part of ISO 81060.This part of ISO 81060 specifies additional disclosure requirements for the ACCOMPANYING DOCUMENTS of SPHYGMOMANOMETERS that have undergone CLINICAL INVESTIGATION according to this part of ISO 81060.This part of ISO 81060 is not applicable to CLINICAL INVESTIGATIONS of NON-AUTOMATED SPHYGMOMANOMETERS as given in ISO 81060-1 or INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as given in IEC 60601-2-34.
【中国标准分类】 C46 医药器械
【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备
国际标准 ISO 81060-2-2009/COR.1-2011 无创血压计--第2部分：间歇性自动测量型的临床研究
【适用范围】This document specifies the requirements and methods for the clinical investigation of
me equipment used for the intermittent non-invasive automated estimation of the arterial blood
pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations flow or
sounds for the estimation display or recording of blood pressure. These sphygmomanometers need
not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and
weight ranges) and all conditions of use (e.g. ambulatory blood pressure monitoring stress testing
blood pressure monitoring and blood pressure monitors for the home healthcare environment
for self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation
according to this document.
This document specifies additional disclosure requirements for the accompanying documents of
sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers
as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
me equipment used for the intermittent non-invasive automated estimation of the arterial blood
pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations flow or
sounds for the estimation display or recording of blood pressure. These sphygmomanometers need
not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and
weight ranges) and all conditions of use (e.g. ambulatory blood pressure monitoring stress testing
blood pressure monitoring and blood pressure monitors for the home healthcare environment
for self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation
according to this document.
This document specifies additional disclosure requirements for the accompanying documents of
sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers
as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
【中国标准分类】 C46 医药器械
【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备
国际标准 ISO/IEC 80601-2-30-2009 无创血压计--第5部分:自动无创血压计测试用NIBP模拟器的重复性和再现性要求
【适用范围】This document specifies requirements for the repeatability and reproducibility of non-invasive blood
pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.
In addition the pulse rate set on the NIBP simulator is tested.
This document is not intended to relate the signals generated by the NIBP simulator to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing such as design or elastic properties).
NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.
This document does not check whether or not the NIBP simulator is able to test the accuracy of the
absolute blood pressure value of oscillometric automated sphygmomanometers.
NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.
This document is applicable to NIBP simulators testing automated sphygmomanometers for adults
children and neonates at the upper arm thigh etc. and automated sphygmomanometers measuring at the wrist.
pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.
In addition the pulse rate set on the NIBP simulator is tested.
This document is not intended to relate the signals generated by the NIBP simulator to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing such as design or elastic properties).
NOTE 1 These parameters can be tested separately in a clinical investigation or by using different special test setups.
This document does not check whether or not the NIBP simulator is able to test the accuracy of the
absolute blood pressure value of oscillometric automated sphygmomanometers.
NOTE 2 Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.
This document is applicable to NIBP simulators testing automated sphygmomanometers for adults
children and neonates at the upper arm thigh etc. and automated sphygmomanometers measuring at the wrist.
【中国标准分类】 C30 医药器械
【国际标准分类】 11.040.10-麻醉、呼吸和复苏设备
国外标准 BS EN 1060-1-1995+A2-2009 非侵入式血压计规范.一般要求
【适用范围】This Part of this European Standard specifies general requirements for non-invasive sphygmomanometersand their accessories which
by means of an inflatable cuff
are used for the non-invasive measurement ofarterial blood pressure.It specifies performance
efficiency
mechanical and electrical safety requirements for these devices and givestest methods.
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 1060-1-1996(R2003) 非侵入式血压计.第1部分:一般要求
【适用范围】
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 1060-1-1996(R2007) 非侵入式血压计规范.机械血压计的补充要求
【适用范围】
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 1060-3-1997(R2003) 非侵入式血压计.电动机械血压测量系统的补充要求
【适用范围】
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 1060-3-1997 非侵入式血压计.自动非侵入式血压计的整个系统准确度测定的试验规程
【适用范围】
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 1060-3-1997+A2-2009 非侵入式血压计.机电式血压计量设备的补充要求
【适用范围】This Part of EN 1060 specifies performance
efficiency and safety requirements for electro-mechanical blood pressure measuring systems that
by means of an inflatable cuff are used for non-invasive measurements of arterial blood pressure at the upper arm
the wrist and the thigh. It also specifies requirements for their accessories and gives test methods.This Part of EN 1060 applies to electro-mechanical blood pressure measuring systems in which the cuffpressure is measured electronically
but in which the blood pressure can be determined either manually with the aid of a stethoscope or automatically.Additional safety requirements for automatic cycling indirect blood pressure monitoring equipment arespecified in EN 60601-2-30:1995.This Part of EN 1060 is to be used in conjunction with EN 1060-1.
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS EN 80601-2-30-2010+A1-2015 非侵入式血压计.非自动测量式血压计的要求和试验方法
【适用范围】
【中国标准分类】 C47 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 BS ISO 81060-2-2009 非侵入式血压计.自动测量式血压计的临床有效性
【适用范围】
【中国标准分类】 C39 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 JIS T1115-2018 非侵入式机电血压计
【适用范围】この規格は，膨張可能なカフを用いて非侵襲的に不連統な血圧を間接的に測定する電子皿圧針の基礎安
全及び基本性能について規定する。
全及び基本性能について規定する。
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 JIS T1115-2005 非直观式电子血压计
【适用范围】この規格は，膨張可能なカフを用いて非侵襲的に動脈血圧を測定する非観血式電子血圧計又は非観血式自動血圧計(以下，血圧計という。)，及び附属品の一般原則，性能，有効性並びに機械的?電気的な安全性の要求事項について規定する。また，この規格は，型式承認のための試験方法も規定する。
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 JIS T1115-1987 非侵入式血压计.第1部分:一般要求
【适用范围】The document specifies general requirements for non-invasive sphygmomanometers and their accessories which
by means of an inflatable cuff
are used for the non-invasive measurement of arterial blood pressure. It specifies performance
efficiency
mechanical and electrical safety requirements for these devices and gives test methods.
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
国外标准 DIN EN 1060-1-1995 非闯入式血压计.第1部分:一般要求
【适用范围】
【中国标准分类】 C38 医药器械
【国际标准分类】 11.040.55-诊断设备
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