IEC 80601-2-30:2009

Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers

Publication date:   Feb 2, 2009

95.99 Withdrawal of Standard   Mar 23, 2018

General information

95.99 Withdrawal of Standard   Mar 23, 2018

IEC

ISO/TC 121/SC 3 Respiratory devices and related equipment used for patient care

International Standard

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope


IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It 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. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.      

Life cycle

NOW

WITHDRAWN
IEC 80601-2-30:2009
95.99 Withdrawal of Standard
Mar 23, 2018

CORRIGENDA / AMENDMENTS

Amended by
IEC 80601-2-30:2009/Amd 1:2013

REVISED BY

PUBLISHED
IEC 80601-2-30:2018