Norm

IEC 80601-2-30:2018-RL en

Medische elektrische toestellen - Deel 2-30: Speciale eisen voor basisveiligheid en essentiƫle prestaties van niet-invasieve bloeddrukmeters (Redline versie met track changes)

291,65 352,90 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 179
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-03-2018
Taal Engels
IEC 80601-2-30:2018 RLV contains the International Standard and its Redline version. The Redline version is available in English only. The Redline version provides you with a quick and easy way to compare all the changes between this standard and its previous edition. The Redline version is not an official IEC Standard, only the current version of the standard is to be considered the official document. IEC 80601-2-30:2018 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 non continuous indirect estimation of the blood pressure without arterial puncture. This document 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 document covers automatic electrically-powered ME equipment used for the intermittent, indirect estimation of the blood pressure without arterial puncture, including blood pressure monitors for the home healthcare environment. Requirements for indirect estimation 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. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005. This second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015; b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12; c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series; d) added additional requirements for public self-use sphygmomanometers; e) added a list of primary operating functions.

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische toestellen - Deel 2-30: Speciale eisen voor basisveiligheid en essentiƫle prestaties van niet-invasieve bloeddrukmeters (Redline versie met track changes)
Engelse titel Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers (Redline version with track changes)

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