Overview

This part of ISO 81060 specifies requirements for non-automated, non-invasive sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation. It 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. It covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow, for example, a stethoscope for detecting Korotkoff sounds, Doppler ultrasound or other manual methods. The clinical investigation of non-invasive sphygmomanometers of automated measurement type is dealt with in ISO 81060-2. Requirements for non-invasive blood pressure measurement equipment with electrically-powered pressure sensing elements and/or displays used in conjunction with other automatic methods determining blood pressure are specified in DIN EN 80601-2-30 (VDE 0750-2-30). Requirements for invasive blood pressure measurement equipment that directly measure blood pressure are specified in document DIN EN 60601-2-34 (VDE 0750-2-34). This part of ISO 81060 is a product standard which is directed at manufacturers and test institutes. The committee responsible for this standard is NA 027-02-14 AA "Nichtinvasive Blutdruckmessgeräte" ("Non-invasive sphygmomanometers") at DIN.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 027-06-01 AA - Non-invasive sphygmomanometer  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 121/SC 3/JWG 7 - Joint ISO/TC 121/SC 3-IEC/SC 62D WG : Non-invasive blood pressure monitoring equipment