BS EN 61391-2:2010

Overview

BS EN 61391-2:2010 is a crucial standard within the Health Care Technology sector, specifically addressing ultrasonics and pulse-echo scanners. This standard provides guidelines for the measurement of maximum depth of penetration and local dynamic range, ensuring that ultrasonic equipment meets the necessary performance criteria for medical applications.

Key Requirements

The standard outlines specific requirements for the evaluation of pulse-echo scanners used in medical diagnostics. Key aspects include:

• Measurement Techniques: Detailed methodologies for assessing the maximum depth of penetration and local dynamic range of ultrasonic systems.
• Calibration Procedures: Guidelines for the calibration of equipment to ensure accurate measurements and reliable performance.
• Performance Criteria: Establishes minimum performance thresholds that must be met for compliance, ensuring the safety and efficacy of ultrasonic devices.

Implementation Benefits

Adopting BS EN 61391-2:2010 brings several practical benefits to healthcare providers and manufacturers:

• Enhanced Diagnostic Accuracy: By adhering to the measurement standards, healthcare professionals can achieve more reliable diagnostic results, improving patient outcomes.
• Quality Assurance: Regular compliance with the standard fosters a culture of quality assurance, ensuring that equipment is consistently performing at optimal levels.
• Market Competitiveness: Manufacturers that comply with this standard can enhance their market position by demonstrating a commitment to quality and safety.

Compliance Value

Compliance with BS EN 61391-2:2010 is essential for manufacturers and healthcare facilities. It not only ensures adherence to regulatory requirements but also mitigates risks associated with the use of ultrasonic technology. The standard aligns with other international standards, such as EN 61747-2-2:2004 and IEC 61391-2:2010, promoting a unified approach to quality in healthcare technology.

Furthermore, compliance can facilitate smoother regulatory approvals and enhance the credibility of products in the eyes of stakeholders, including healthcare providers, regulatory bodies, and patients. In an industry where precision and reliability are paramount, BS EN 61391-2:2010 serves as a foundational document that supports the safe and effective use of ultrasonic diagnostic equipment.