BS 5194-2:1989

Overview

BS 5194-2:1989 provides essential specifications for surgical instruments featuring pivot joints, excluding cutting instruments. This standard is crucial for manufacturers, healthcare providers, and compliance professionals involved in the design, production, and utilisation of surgical instruments. It ensures that these instruments meet rigorous safety and performance criteria, thereby enhancing patient care and operational efficiency.

Key Requirements

The standard outlines specific requirements for the design and construction of pivot joint instruments. Key aspects include:

• Materials: The standard specifies acceptable materials that ensure durability and biocompatibility.
• Design Specifications: Detailed guidelines on the dimensions and tolerances of pivot joints to ensure optimal functionality.
• Performance Testing: Requirements for testing the mechanical properties and performance of instruments under simulated surgical conditions.
• Marking and Labelling: Standards for clear identification and traceability of instruments, which is vital for compliance and safety.

Implementation Benefits

Adhering to BS 5194-2:1989 offers numerous benefits for healthcare technology stakeholders:

• Enhanced Safety: Compliance with the standard minimises risks associated with instrument failure during surgical procedures.
• Improved Quality Control: Establishing a robust quality assurance framework based on the standard's requirements leads to higher quality instruments.
• Streamlined Production: Clear specifications facilitate efficient manufacturing processes, reducing waste and production costs.
• Market Acceptance: Instruments compliant with BS 5194-2:1989 are more likely to gain acceptance in healthcare facilities, enhancing marketability.

Compliance Value

Compliance with BS 5194-2:1989 is not merely a regulatory requirement; it is a commitment to excellence in healthcare technology. The standard aligns with international best practices, ensuring that instruments are safe and effective for surgical use. By adhering to these specifications, manufacturers can:

• Meet Regulatory Requirements: Fulfil local and international regulations governing medical devices.
• Enhance Patient Outcomes: Provide healthcare professionals with reliable instruments that contribute to successful surgical outcomes.
• Build Trust: Establish credibility with healthcare providers and patients through demonstrated commitment to quality and safety.

In conclusion, BS 5194-2:1989 serves as a foundational standard for the development and use of surgical instruments with pivot joints. Its comprehensive specifications ensure that instruments are not only functional but also safe for patient use. Compliance with this standard is essential for manufacturers aiming to deliver high-quality healthcare technology.