Overview
EN ISO 81060-2:2019/A1:2020 is an important amendment to the international standard governing non-invasive sphygmomanometers, specifically focusing on the clinical investigation of intermittent automated blood pressure measurement devices. Developed jointly by ISO Technical Committee ISO/TC 121 and CEN Technical Committee CEN/TC 205, this amendment updates Part 2 of the ISO 81060 standard series, ensuring improved accuracy and consistency in clinical evaluations. The document applies to automated intermittent sphygmomanometers used for blood pressure monitoring without invasive methods.
The amendment updates key elements regarding subject limb size distribution, cuff specifications, and clinical investigation reporting. It enforces rigorous testing protocols to better represent diverse patient populations and enhance device reliability.
Key Topics
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Limb Circumference Range Requirements
- Defines total limb circumference range as the spectrum from smallest to largest limb circumference intended by the manufacturer.
- Mandates at least 20% of test subjects to fall into each quarter of the total limb circumference range.
- Requires minimum 10% of subjects to fall within both the highest and lowest octiles of the limb circumference range.
- Specifies formulas to distribute testing subjects across multiple cuff sizes when applicable.
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Cuff Design and Reference Specifications
- Reference cuffs must include a bladder length measuring 75% to 100% of the upper arm circumference.
- Bladder width must be 37% to 50% of the upper arm circumference.
- Cuffs shall have a two-piece construction: distensible inner bladder and non-distensible outer sleeve.
- Ensures cuff design compatibility with varying limb sizes for accurate readings.
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Clinical Investigation Reporting
- Reports must detail each cuff's specified arm circumference range in centimeters and inches.
- Inclusion of plots correlating arm circumference to the difference between device and reference blood pressure readings.
- Separate plots required for both systolic and diastolic blood pressure values.
- Visual demarcation of cuff size borders on plots to facilitate scientific review.
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Compliance Verification
- National bodies are tasked with adopting this amendment as a national standard.
- Conflicting national standards must be withdrawn to harmonize sphygmomanometer clinical testing.
- Focus on patent rights notification related to the document's technical content.
Applications
This standard amendment is critical for manufacturers, clinical researchers, and regulatory bodies involved in the development, testing, and certification of non-invasive automated sphygmomanometers. Practical applications include:
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Medical Device Development
Ensures product design incorporates appropriate cuff sizes and limb distribution considerations to suit diverse patient populations.
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Clinical Trials and Validation
Standardizes protocols for blood pressure monitoring device validation through rigorous clinical investigations ensuring measurement accuracy.
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Regulatory Compliance
Assists regulatory authorities in Europe and internationally in assessing device conformity with up-to-date accuracy and safety requirements.
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Quality Assurance in Healthcare Settings
Supports healthcare providers in selecting sphygmomanometers that meet validated clinical performance standards for intermittent automated blood pressure measurement.
Related Standards
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EN ISO 81060-1:2007
Covers the non-invasive sphygmomanometers - Part 1: Requirements and test methods for automated measurement types. Provides foundational definitions such as bladder specifications referenced in this amendment.
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ISO 81060 series
A series of standards addressing different aspects of sphygmomanometer design, testing, and clinical performance evaluation.
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IEC 80601-2-30
Medical electrical equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers. Complements ISO 81060-2 by addressing electrical safety and performance.
Keywords: non-invasive sphygmomanometer, automated blood pressure measurement, clinical investigation, limb circumference range, cuff size distribution, ISO 81060-2 amendment, blood pressure accuracy, medical device standards, sphygmomanometer validation, European standard CEN, patient safety, clinical testing protocols.