Account:  - Login  |  Webstore  |  Shopping basket cart
English  |  Français  |  Nederlands

Publication details

Publication CODE Title
ISO 81060-2:2018 (2018-11) NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE
 
Price Excl. VAT Total number of pages, tables and drawings
183.00 € 36.
Description
ISO 81060-2:2018 This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.
This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN version

FR version

Status
Status IEC PUBLICATION
Situation Currently active
Partly replaces  ISO 81060-2:2013
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2018-11-21
ICS-Code (International Standards Classification) 11.040.10
NBN Status New
IEC publication date 2018-11-21
IEC stability date 2022-12-31
IEC file modification date 2018-11-22
IEC last modification date 2019-07-10