EN ISO 81060-1:2012

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

Publication date:   Jul 17, 2012

General information

60.60 Standard published   May 23, 2012

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.
ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.
ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 1060-2:1995+A1:2009

WITHDRAWN
EN 1060-1:1995+A2:2009

NOW

PUBLISHED
EN ISO 81060-1:2012
60.60 Standard published
May 23, 2012

Relations

Adopted from ISO 81060-1:2007 IDENTICAL