BS EN ISO 81060-3:2022

Non-invasive sphygmomanometers Clinical investigation of continuous automated measurement type

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Standard number:	BS EN ISO 81060-3:2022
Pages:	48
Released:	2023-01-20
ISBN:	978 0 539 01031 2
Status:	Standard

BS EN ISO 81060-3:2022 Non-invasive Sphygmomanometers Clinical Investigation of Continuous Automated Measurement Type

Introducing the BS EN ISO 81060-3:2022, a comprehensive standard for non-invasive sphygmomanometers that are designed for continuous automated measurement. This standard is a must-have for healthcare professionals, medical device manufacturers, and quality assurance teams who are committed to ensuring the highest level of accuracy and reliability in blood pressure monitoring.

Released on January 20, 2023, this standard is the latest in the series, reflecting the most recent advancements in non-invasive blood pressure monitoring technology. With a total of 48 pages, it provides an in-depth guide to the clinical investigation of these devices, ensuring they meet the stringent requirements for medical use.

Key Features

The BS EN ISO 81060-3:2022 standard is packed with essential information and guidelines, including:

Comprehensive protocols for the clinical investigation of non-invasive sphygmomanometers.
Clear definitions of key terms and concepts related to blood pressure monitoring.
Detailed descriptions of the design and operational principles of continuous automated measurement devices.
Guidelines for the evaluation and interpretation of measurement results.

Why Choose BS EN ISO 81060-3:2022?

As a globally recognized standard, the BS EN ISO 81060-3:2022 is a testament to your commitment to quality and safety. By adhering to this standard, you can ensure that your non-invasive sphygmomanometers are clinically reliable and suitable for continuous automated measurement.

Moreover, this standard is an invaluable resource for understanding the complexities of blood pressure monitoring technology. Whether you're a healthcare professional seeking to enhance patient care, a manufacturer aiming to produce top-quality devices, or a quality assurance team striving to uphold the highest standards, the BS EN ISO 81060-3:2022 is an indispensable tool.

Order Your Copy Today

Don't miss out on this essential standard. Order your copy of the BS EN ISO 81060-3:2022 today and take the first step towards superior blood pressure monitoring. The standard comes with an ISBN number 978 0 539 01031 2, ensuring its authenticity and credibility.

Stay ahead of the curve with the BS EN ISO 81060-3:2022 standard. Invest in quality, safety, and accuracy in non-invasive blood pressure monitoring. Order your copy today!

Note: This product is a standard and therefore not subject to return or refund once purchased.

DESCRIPTION

BS EN ISO 81060-3:2022

This standard BS EN ISO 81060-3:2022 Non-invasive sphygmomanometers is classified in these ICS categories:

11.040.10 Anaesthetic, respiratory and reanimation equipment
11.040.55 Diagnostic equipment

This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient. This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer. This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document. NOTE 1 IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values. The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers. NOTE 2 Subject populations can, for example, be represented by age or weight ranges. NOTE 3 This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject). This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document. This document is not applicable to: — the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1, — the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2, — an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or — invasive blood pressure monitoring equipment as given in IEC 60601?2?34.

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