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

Medical Device Product Working Group (MDPWG)

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