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DIN Standards Committee Optics and Precision Mechanics

Overview

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). 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. This document is not applicable to CLINICAL INVESTIGATIONS of a set of CUFFS that are not of same materials and construction. Each type of CUFF set is required to be evaluated separately according to this document. This document contains a second amendment. The amendments were introduced to resolve the problems caused by Amendment 1. The amendments were introduced to take test subjects who require particularly large cuff sizes into account. The responsible national committee is Working Committee NA 027-06-01 AA "Nichtinvasive Blutdruckmessgeräte" ("Non-invasive blood pressure measuring devices") at DIN Standards Committee Optics and Precision Mechanics (NAFuO).

Document: references 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