Standard Update - Non-invasive blood pressure measurement standard update information
With the implementation of the third edition of the general standard for medical devices, the special standards for medical devices have changed frequently recently. Among them, the special standards for non-invasive blood pressure measurement have been updated as follows:-- ETL certification agency
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
Applicable to non-invasive blood pressure measurement equipment for non-automatic measurement (such as manual or used with a stethoscope), which specifies basic safety and basic performance requirements.
Scope (scope of application, quoted from the description of this standard):
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.
This standard applies to non-invasive blood pressure devices and their accessories (such as blood pressure cuffs) that are not automatically measured and measured by cuff inflation (such as manual measurement). It specifies the requirements for their safety and basic performance, such as effectiveness and labeling.
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
Applicable to electronic non-invasive blood pressure measurement equipment, it specifies the requirements and methods for clinical validation.
Scope (scope of application, quoted from the description of this standard):
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 (eg all age and weight ranges), and all conditions of use (eg 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.
This standard specifies requirements and methods for clinical validation of automatic, non-invasive blood pressure devices using a cuff.
This standard covers blood pressure measuring devices intended for use in all patient populations (e.g., patients of all age and weight ranges) and in all application conditions (ambulatory blood pressure monitoring devices, stationary blood pressure monitoring devices, including self-measurement sphygmomanometers for home use).
Example: Clinical validation of blood pressure measurement equipment to IEC 80601-2-30 follows this standard (ISO 81060-2.)
This standard does not apply to non-automatic blood pressure measurement devices as described in ISO 81060-1, nor to invasive blood pressure measurement devices as described in IEC 60601-2-34.
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
Applicable to electronic non-invasive blood pressure measurement equipment, it specifies basic safety and essential performance requirements.
Scope (scope of application, quoted from the description of this standard):
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
Automatic cycle blood pressure measurement equipment
EN 60601-2-30:2000 or
IEC 60601-2-30:1999
Mechanical blood pressure measuring devices
European standard
EN 1060-1:1995+A2:2009
EN 1060-2:1995+A1:2009
ISO 81060-1:2007
American standard
ANSI/AAMI SP10:2002//A1:2003/ A2:2006/(R)2008
Electronic non-invasive blood pressure measurement equipment
Clinical requirements
European standard
EN 1060-4:2004
ISO 81060-2:2009
