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ISO 81060-2:2013

Non-invasive sphygmomanometers -- Part 2: Clinical investigation of automated measurement type

General information

Withdrawn from 21.11.2018
ICS Groups
11.040.10 Anaesthetic, respiratory and reanimation equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
21.11.2018
Main
ISO 81060-2:2018
11.02.2011
Corrigendum
ISO 81060-2:2009/Cor 1:2011
Main
ISO 81060-2:2013
Main
ISO 81060-2:2009
ISO 81060-2:2013 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.
ISO 81060-2:2013 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.
ISO 81060-2:2013 covers sphygmomanometers intended for use in all patient populations and all conditions of use.
ISO 81060-2:2013 specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have undergone clinical investigation according to ISO 81060-2:2013.

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Standard monitoring
English (PDF 239 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English