PD ISO/TS 81060-5:2020
Non-invasive sphygmomanometers Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
| Standard number: | PD ISO/TS 81060-5:2020 |
| Pages: | 20 |
| Released: | 2020-02-05 |
| ISBN: | 978 0 580 99605 4 |
| Status: | Standard |
PD ISO/TS 81060-5:2020 Non-invasive Sphygmomanometers
Discover the essential standard for ensuring the accuracy and reliability of automated non-invasive sphygmomanometers with the PD ISO/TS 81060-5:2020. This technical specification is a must-have for professionals in the medical device industry, providing comprehensive guidelines for the repeatability and reproducibility of NIBP (Non-Invasive Blood Pressure) simulators.
Overview
The PD ISO/TS 81060-5:2020 is a pivotal document that sets forth the requirements for testing automated non-invasive sphygmomanometers. Released on February 5, 2020, this standard is designed to ensure that these medical devices deliver consistent and accurate blood pressure readings, which are crucial for patient diagnosis and treatment.
Key Features
- Standard Number: PD ISO/TS 81060-5:2020
- Pages: 20
- Release Date: 2020-02-05
- ISBN: 978 0 580 99605 4
- Status: Standard
Why This Standard is Important
In the realm of healthcare, precision and reliability are paramount. Automated non-invasive sphygmomanometers are widely used in clinical settings to monitor blood pressure, a critical indicator of cardiovascular health. The PD ISO/TS 81060-5:2020 standard ensures that these devices are tested rigorously for repeatability and reproducibility, minimizing the risk of inaccurate readings that could lead to misdiagnosis or inappropriate treatment.
By adhering to this standard, manufacturers can guarantee that their devices meet the highest quality benchmarks, thereby enhancing their credibility and trustworthiness in the market. Healthcare providers, in turn, can rely on these devices to deliver consistent results, improving patient outcomes and safety.
Comprehensive Testing Guidelines
The document provides detailed guidelines on the testing procedures for NIBP simulators, which are used to evaluate the performance of automated sphygmomanometers. These guidelines cover various aspects, including:
- Calibration and validation of NIBP simulators
- Assessment of measurement accuracy and precision
- Evaluation of device performance under different conditions
- Documentation and reporting of test results
By following these guidelines, manufacturers can ensure that their devices are not only compliant with international standards but also capable of delivering reliable and repeatable measurements in real-world clinical settings.
Who Should Use This Standard?
The PD ISO/TS 81060-5:2020 is an invaluable resource for a wide range of stakeholders in the healthcare and medical device industries, including:
- Medical device manufacturers seeking to ensure the quality and reliability of their products
- Healthcare providers and institutions aiming to maintain high standards of patient care
- Regulatory bodies responsible for overseeing the safety and efficacy of medical devices
- Research and development teams focused on innovating and improving sphygmomanometer technology
Conclusion
The PD ISO/TS 81060-5:2020 standard is a critical tool for ensuring the accuracy and reliability of automated non-invasive sphygmomanometers. By providing clear and comprehensive guidelines for testing NIBP simulators, this document helps manufacturers, healthcare providers, and regulatory bodies maintain the highest standards of quality and safety in blood pressure monitoring.
Whether you are a manufacturer looking to enhance your product's credibility, a healthcare provider committed to delivering the best patient care, or a regulatory body focused on upholding industry standards, the PD ISO/TS 81060-5:2020 is an essential addition to your professional library.
PD ISO/TS 81060-5:2020
This standard PD ISO/TS 81060-5:2020 Non-invasive sphygmomanometers is classified in these ICS categories:
- 11.040.10 Anaesthetic, respiratory and reanimation equipment
This document specifies requirements for the repeatability and reproducibility of non-invasive blood pressure (NIBP) simulators intended to test automated sphygmomanometers utilizing the oscillometric non-continuous method only.
In addition, the pulse rate set on the NIBP simulator is tested.
This document is not intended to relate the signals, generated by the NIBP simulator, to the oscillometric signal recorded in a cuff attached to a human. It does not intend to test the interaction between the NIBP simulator and the tested automated sphygmomanometer (e.g. the agreement of the set values of the NIBP simulator and the displayed values of the tested automated sphygmomanometer or the properties of the cuff and tubing, such as design or elastic properties).
These parameters can be tested separately in a clinical investigation or by using different special test setups.
This document does not check whether or not the NIBP simulator is able to test the accuracy of the absolute blood pressure value of oscillometric automated sphygmomanometers.
Usually this is tested by a clinical investigation according ISO 81060-2 or other protocols.
This document is applicable to NIBP simulators testing automated sphygmomanometers for adults, children and neonates at the upper arm, thigh etc. and automated sphygmomanometers measuring at the wrist.