EN 80601-2-30:2010

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

Publication date:   Nov 16, 2010

General information

99.60 Withdrawal effective   May 24, 2022

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040   Medical 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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-30:2000

NOW

WITHDRAWN
EN 80601-2-30:2010
99.60 Withdrawal effective
May 24, 2022

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 80601-2-30:2010/A1:2015

REVISED BY

PUBLISHED
EN IEC 80601-2-30:2019