Overview
ISO 81060-2:2018/Amd 1:2020 is an important amendment to the international standard governing non-invasive sphygmomanometers-specifically addressing the clinical investigation of intermittent automated measurement types. This amendment refines critical parameters such as limb circumference distribution, cuff sizing, and reporting requirements to ensure accurate and reliable blood pressure measurement using automated devices. Developed by ISO in collaboration with IEC, this standard supports manufacturers, healthcare providers, and regulators in maintaining high-quality clinical evaluation practices for sphygmomanometers.
Key Topics
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Limb Circumference Distribution Requirements
The amendment specifies detailed criteria for the distribution of limb circumferences among test subjects during clinical investigations:
- At least 20% of subjects' limb sizes must fall within each quarter of the total intended limb circumference range.
- At least 10% must be within both the lowest and highest octiles of this range.
- For devices with multiple cuff sizes, each cuff must be tested with a calculated minimum number of subjects proportional to its coverage within the limb circumference range.
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Cuff Specifications for Reference Devices
The standard defines criteria for cuffs used on reference sphygmomanometers, including:
- Bladder length between 75% to 100% of the upper arm circumference.
- Bladder width between 37% to 50% of the upper arm circumference.
- A two-piece construction consisting of a distensible inner bladder and a non-distensible outer sleeve.
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Clinical Investigation Reporting
The clinical investigation report must provide:
- Specified arm circumference ranges for each cuff size in both centimeters and inches.
- Graphical plots showing differences between test device and reference blood pressure values against arm circumference.
- Plots for both systolic and diastolic blood pressures, with clear demarcation of cuff size boundaries indicated by vertical lines.
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Definition Additions
New terms such as total limb circumference range are introduced to clarify the full span of limb sizes intended for device use, aiding in consistent interpretation and application of the standard.
Applications
ISO 81060-2:2018/Amd 1:2020 is essential for:
- Medical Device Manufacturers
Ensuring automated sphygmomanometers meet rigorous clinical performance benchmarks before market entry, improving device accuracy and reliability.
- Clinical Researchers
Providing established methodologies for validating automated blood pressure measurement devices across varying patient demographics and limb sizes.
- Regulatory Authorities
Guiding evaluation protocols for approval and post-market surveillance of non-invasive automated blood pressure monitors to ensure patient safety.
- Healthcare Providers
Facilitating confidence in automated sphygmomanometer readings, supporting better patient diagnosis and management.
Related Standards
- ISO 81060-1:2007 - Specifies requirements for non-invasive sphygmomanometers regarding the physical and electrical characteristics of the device cuff and measurement accuracy during clinical investigation.
- IEC 81060 Series - Provides related standards developed jointly with IEC, focusing on electrical equipment used in medical practice, particularly electromedical devices.
Keywords
ISO 81060-2:2018/Amd 1:2020, non-invasive sphygmomanometer, automated blood pressure monitor, clinical investigation, limb circumference distribution, cuff sizing, blood pressure measurement standard, sphygmomanometer amendment, medical device standards, healthcare measurement accuracy.
Open preview (PDF)Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type — Amendment 1
