Title Of Document
Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type
Abstract
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.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 81060-1:2007
ICS
HS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
Member States
ID
Date of harmonisation in ASEAN
Date of Latest Review
Links :
ISO 81060-1:2007 Non-invasive sphygmomanometers -- Part 1: Requirements and test methods for non-automated measurement type