Standard Update-Non-invasive Sphygmomanometer Standard Update Information

   

With the implementation of the third edition of the General Standards for Medical Devices, recent changes in the specific standards for medical devices have been frequent. The current standard for noninvasive blood pressure measurement is updated as follows：--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

 

Scope

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.

    　

 

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

　　

　　Scope

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.

　　

    

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

　　

　　Scope 

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.

　

 

Standard Correspondence of New and Old Versions of Noninvasive Blood Pressure Measurement Equipment

project

Old version

new version

Electronic blood pressure measuring equipment

EN 1060-1:1995+A2:2009

EN 1060-3:1997+A2:2009

IEC 80601-2-30: 2009

EN 80601-2-30:2010

Automatic circulating blood pressure measuring equipment

EN 60601-2-30:2000 or

IEC 60601-2-30:1999

Mechanical blood pressure measuring equipment

European standards

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 noninvasive blood pressure measurement equipment

Clinical requirements

European standards

EN 1060-4:2004

ISO 81060-2:2009