BS EN 61847:1998, IEC 61847:1998

Overview

BS EN 61847:1998, also known as IEC 61847:1998, is a critical standard within the health care technology sector, specifically focusing on ultrasonics used in surgical systems. This standard provides a framework for the measurement and declaration of basic output characteristics of ultrasonic surgical systems. It is essential for ensuring that these systems operate effectively and safely, meeting the necessary performance criteria for patient care.

Key Requirements

The standard outlines several key requirements that manufacturers and healthcare providers must adhere to when dealing with ultrasonic surgical systems. These include:

• Measurement Protocols: Detailed methodologies for measuring the output characteristics of ultrasonic devices.
• Output Characteristics: Specifications for the declaration of parameters such as frequency, power output, and intensity.
• Safety Considerations: Guidelines to ensure that ultrasonic systems do not pose risks to patients or operators.
• Performance Verification: Procedures for verifying that systems meet the declared output characteristics.

Implementation Benefits

Adopting BS EN 61847:1998 offers numerous benefits for healthcare technology manufacturers and providers:

• Enhanced Safety: By following the measurement and declaration protocols, manufacturers can ensure that their devices operate within safe parameters, reducing the risk of adverse effects during surgical procedures.
• Improved Device Performance: The standard encourages rigorous testing and validation, leading to higher quality and more reliable ultrasonic systems.
• Market Confidence: Compliance with this standard can enhance the credibility of manufacturers, fostering trust among healthcare providers and patients.
• Regulatory Compliance: Adhering to BS EN 61847:1998 can facilitate compliance with broader regulatory requirements, easing the path to market entry for new devices.

Compliance Value

Compliance with BS EN 61847:1998 is not merely a regulatory obligation; it is a commitment to quality and safety in healthcare technology. By ensuring that ultrasonic surgical systems meet the standards set forth in this document, manufacturers can:

• Minimise Liability: Reducing the risk of litigation related to device failures or patient harm.
• Enhance Reputation: Building a reputation for quality and safety that can lead to increased market share.
• Facilitate International Trade: As an internationally recognised standard, compliance can ease the export of devices to other markets.

In conclusion, BS EN 61847:1998 is a vital standard for the health care technology sector, particularly for ultrasonic surgical systems. Its comprehensive guidelines for measurement and declaration of output characteristics ensure that devices are safe, effective, and compliant with regulatory expectations. Manufacturers and healthcare providers who adhere to this standard will not only enhance patient safety but also improve the overall quality of care.