BS EN ISO 81060-2:2019+A2:2024 Non-invasive Sphygmomanometers: Clinical Investigation of Intermittent Automated Measurement Type

Standard Number: BS EN ISO 81060-2:2019+A2:2024

Pages: 52

Released: 2024-05-16

ISBN: 978 0 539 23575 3

Status: Standard

Overview

The BS EN ISO 81060-2:2019+A2:2024 standard is an essential document for anyone involved in the clinical investigation of non-invasive sphygmomanometers, specifically those designed for intermittent automated measurement. This comprehensive standard provides detailed guidelines and requirements to ensure the accuracy, reliability, and safety of these medical devices.

Why Choose This Standard?

In the rapidly evolving field of medical technology, maintaining high standards is crucial. The BS EN ISO 81060-2:2019+A2:2024 standard is meticulously crafted to help healthcare professionals, researchers, and manufacturers adhere to the highest levels of quality and performance. Here are some compelling reasons to choose this standard:

• Comprehensive Guidelines: This standard covers all aspects of clinical investigation for non-invasive sphygmomanometers, ensuring that every detail is addressed.
• Up-to-Date Information: Released on 2024-05-16, this standard includes the latest amendments and updates, reflecting the most current industry practices and technological advancements.
• Global Recognition: As an ISO standard, it is recognized and respected worldwide, facilitating international collaboration and compliance.
• Enhanced Patient Safety: By following this standard, healthcare providers can ensure that their devices meet stringent safety and performance criteria, ultimately benefiting patient care.

Key Features

The BS EN ISO 81060-2:2019+A2:2024 standard is packed with features designed to support the clinical investigation of non-invasive sphygmomanometers:

• Detailed Protocols: Step-by-step protocols for conducting clinical investigations, ensuring consistency and reliability in results.
• Performance Criteria: Clear criteria for evaluating the performance of sphygmomanometers, including accuracy, repeatability, and reliability.
• Safety Requirements: Comprehensive safety requirements to protect both patients and healthcare providers during the use of these devices.
• Data Analysis: Guidelines for the analysis and interpretation of clinical data, helping researchers draw meaningful conclusions.
• Documentation: Requirements for thorough documentation, ensuring transparency and traceability throughout the investigation process.

Who Should Use This Standard?

This standard is invaluable for a wide range of professionals and organizations, including:

• Healthcare Providers: Ensure that the sphygmomanometers used in your facility meet the highest standards of accuracy and safety.
• Medical Device Manufacturers: Develop and produce sphygmomanometers that comply with international standards, enhancing your product's credibility and marketability.
• Researchers: Conduct rigorous clinical investigations that adhere to established protocols, ensuring the validity and reliability of your findings.
• Regulatory Bodies: Use this standard as a benchmark for evaluating the compliance of sphygmomanometers with regulatory requirements.

Benefits of Compliance

Adhering to the BS EN ISO 81060-2:2019+A2:2024 standard offers numerous benefits, including:

• Improved Device Performance: Ensure that your sphygmomanometers deliver accurate and reliable measurements, enhancing patient care.
• Increased Trust: Gain the trust of healthcare providers and patients by demonstrating your commitment to quality and safety.
• Regulatory Approval: Facilitate the approval process for your devices by meeting recognized international standards.
• Market Advantage: Stand out in a competitive market by offering products that comply with the latest standards and best practices.

Conclusion

The BS EN ISO 81060-2:2019+A2:2024 standard is an indispensable resource for anyone involved in the clinical investigation of non-invasive sphygmomanometers. By providing comprehensive guidelines and requirements, this standard ensures that these medical devices meet the highest levels of accuracy, reliability, and safety. Whether you are a healthcare provider, manufacturer, researcher, or regulatory body, this standard will help you achieve excellence in your field.

Invest in the BS EN ISO 81060-2:2019+A2:2024 standard today and take a significant step towards enhancing the quality and performance of non-invasive sphygmomanometers in clinical settings.

BS EN ISO 81060-2:2019+A2:2024

This standard BS EN ISO 81060-2:2019+A2:2024 Non-invasive sphygmomanometers is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment
• 11.040.55 Diagnostic equipment
• 11.040.10 Anaesthetic, respiratory and reanimation equipment