ISO 81060-2:2018/AMD1:2020

Amendment 1 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

General Information

• Status: Published
• Publication Date: 07-Jan-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62D/JWG 7
• Current Stage: PPUB - Publication issued
• Start Date: 24-Jun-2020
• Completion Date: 20-Apr-2020

Relations

• Amends: ISO 81060-2:2018 - Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 81060-2
Third edition
2018-11-29
AMENDMENT 1
2020-01
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent
automated measurement type
AMENDMENT 1
Sphygmomanomètres non invasifs —
Partie 2: Investigation clinique pour type ponctuel à mesurage
automatique
AMENDEMENT 1
Reference number
ISO 81060-2:2018/Amd.1:2020(E)
©
ISO 2020

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ISO 81060-2:2018/Amd.1:2020(E)

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ISO 81060-2:2018/Amd.1:2020(E)

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, Electrical equipment in medical practice, Subcommittee SC D,
Electromedical equipment.
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© ISO 2020 – All rights reserved iii

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ISO 81060-2:2018/Amd.1:2020(E)
Non-invasive sphygmomanometers —
Part 2:
Clinical investigation of intermittent automated
measurement type
AMENDMENT 1

Clause 3
Add the following after 3.4:
3.5
total limb circumference range
range, from the smallest limb circumference to the largest limb circumference, intended by the
manufacturer for use with the automated sphygmomanometer

5.1.4
Replace the text with the following, and renumber the subsequent formulae:
5.1.4  * Limb size distribution
a) Limb circumferences shall be distributed as follows:
1) at least 20 % of the subjects shall have a limb circumference which lies within each quarter of
the total limb circumference range;
2) at least 10 % of the subjects shall have a limb circumference which lies within the highest octile
of the total limb circumference range; and
3) at least 10 % of the subjects shall have a limb circumference within the lowest octile of the
total limb circumference range.
b) Additionally, for a sphygmomanometer intended for use with multiple cuff sizes, each cuff shall
be tested on at lea
...