标准更新－无创血压计测量标准更新资讯

   

随着医疗器械通用标准第三版的实施，医疗器械专用标准最近的变更比较频繁。其中目前无创血压测量方面的专用标准，有如下的更新：--ETL认证机构

 

 

1. ISO 81060-1:2007  Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29530

适用于非自动测量（如手动 或 需与听筒配合使用）的无创血压测量设备，规定了基本安全和基本性能的要求。

Scope（适用范围，引自该标准的描述）:

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 pressure measurement by operator observation.

This part of ISO 81060 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods 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-sensing element and display used in conjunction with means of detecting blood flow.

    　该标准适用于非自动测量、通过袖带充气测量（如手动测量）的无创血压设备及其附件（如血压袖带）。规定了其安全和基本性能方面的要求，如有效性及标签。

 

 

2. ISO 81060-2:2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29531

　　适用于电子类无创血压测量设备，规定了临床验证的要求和方法。

　　Scope（适用范围，引自该标准的描述）:

This part of ISO 81060 specifies the requirements and methods for the clinical validation of me equipment used for the intermittent non-invasive automatic 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 or self-measurement).

EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 validated by this part of ISO 81060.

This part of ISO 81060 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers validated according to this part of ISO 81060.

This part of ISO 81060 is not applicable to the validation of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

　　

     这个标准规定了 自动测量的、通过袖带测量的无创血压设备 在临床验证方面的要求和方法。

　　这个标准覆盖了 预期用途用于所有分布的患者（如：所有年龄和重量范围的患者）、所有应用条件（动态血压监测设备、静止的血压监测设备，包括用于家庭的自我测量血压计）的血压测量设备。

　　举例： IEC 80601-2-30适用的血压测量设备的临床验证就是遵循此标准（ISO 81060-2.）

　　这个标准不适用于ISO 81060-1 所提的非自动测量血压设备，也不适用于IEC 60601-2-34所提的有创血压测量设备。

 

3. IEC 80601-2-30:2009  Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=29230

　　适用于 电子类的无创血压测量设备，规定了基本安全和基本性能方面的要求。

　　Scope （适用范围，引自该标准的描述）:

This 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 intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture.

This standard 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 standard covers electrically-powered intermittent, indirect measurement of the BLOOD PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.

Requirements for indirect measurement 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.

　　这个标准适用于自动测量、通过充气袖带、非入侵的间接测量血压设备。

　　这个标准规定了这些设备的基本安全和基本性能方面的要求，包括所需的精度。

　　这个标准适用于电源供电的、非入侵的、间接测量的、自动血压测量设备（即：电子类的无创血压测量设备），包括家用血压计。

　　对于非入侵的间接测量、电源供电压力传感器 和/或 需同听筒配合使用的或其他手动测量方式的 血压计，ISO 81060-1的规定了其要求。

 

 

 

无创血压测量设备 新旧版本标准对应关系

项目

旧版本

新版本

电子类的血压测量设备

EN 1060-1:1995+A2:2009

EN 1060-3:1997+A2:2009

IEC 80601-2-30: 2009

EN 80601-2-30:2010

自动循环血压测量设备

EN 60601-2-30:2000 或

IEC 60601-2-30:1999

机械式的血压测量设备
 

欧洲标准

EN 1060-1:1995+A2:2009

EN 1060-2:1995+A1:2009

ISO 81060-1:2007
 

美国标准

ANSI/AAMI SP10:2002//A1:2003/ A2:2006/(R)2008

电子类无创血压测量设备

临床要求
 

欧洲标准

EN 1060-4:2004

ISO 81060-2:2009