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Standard
ISO 81060-2
Third edition
Non-invasive
2018-11
sphygmomanometers —
AMENDMENT 2
Part 2:
2024-03
Clinical investigation of intermittent
automated measurement type
AMENDMENT 2
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
AMENDEMENT 2
Reference number
ISO 81060-2:2018/Amd.2:2024(en) © ISO 2024
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ISO 81060-2:2018/Amd.2:2024(en)
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© ISO 2024 – All rights reserved
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ISO 81060-2:2018/Amd.2:2024(en)
Foreword
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This document was prepared jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and Technical
Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62D, Particular medical
equipment, software, and systems, in collaboration with the European Committee for Standardization
(CEN) Technical Committee CEN/TC 205, Non-active medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
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© ISO 2024 – All rights reserved
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ISO 81060-2:2018/Amd.2:2024(en)
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
AMENDMENT 2
Scope
Add the following as the last paragraph in the scope:
This document is not applicable to clinical investigations of a set of cuffs that are not of same
materials and construction. Each type of cuff set is required to be evaluated separately according to
this document.
4.2
Add two additional list items after list item c) and before the compliance check:
d) All subjects sh
...