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Norm

ÖNORM EN ISO 81060-2

Issue date: 2014 09 15

Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 81060-2:2013)

his part of ISO 81060 specifies the requirements and methods for the CLINICAL INVESTIGATION of ME EQUIPMENT used for the intermittent non-invasive automated estimation of...
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Withdrawn : 2020 03 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 49 Pages
Language:
German | English | Download GER/ENG
Currently valid:
ÖNORM EN ISO 81060-2:2020 12 01
Optionally co-design standards:
Committee 179: Medical technology
ICS
11.040.55 11.040.10
Topics
Healthcare, Medical equipment, Diagnostic equipment Healthcare, Medical equipment, Anaesthetic, respiratory and reanimation equipment
his part of ISO 81060 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 part of ISO 81060 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 part of ISO 81060 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).
ÖNORM EN ISO 81060-2
2020 12 01
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measuremen...
Norm
ÖNORM EN ISO 81060-2
2020 03 01
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measuremen...
Norm
ÖNORM EN ISO 81060-2
2014 09 15
Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (ISO 8...
Norm
↖
ÖNORM EN 1060-4
2005 01 01
Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of...
Norm
Historie aufklappen
Norm
ISO 81060-1:2007
Issue date : 2007 11 19
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
Norm
ISO 14155:2011
Issue date : 2011 01 21
Clinical investigation of medical devices for human subjects — Good clinical practice
Norm
ISO 81060-1:2007
Issue date : 2007 11 19
Non-invasive sphygmomanometers — Part 1: Requirements and test methods for non-automated measurement type
Norm
ÖNORM EN ISO 81060-2
Issue date : 2020 03 01
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)
Norm
ISO 81060-2:2013
Issue date : 2013 04 18
Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type