BS EN ISO 7198:2017

Overview

BS EN ISO 7198:2017 specifies requirements for vascular prostheses, including tubular vascular grafts and vascular patches used in cardiovascular implants and extracorporeal systems. This standard aims to ensure the safety and effectiveness of these medical devices, which are critical in various surgical procedures involving the vascular system.

Key Requirements

The standard outlines essential criteria that manufacturers must adhere to when designing and producing vascular prostheses. Key requirements include:

• Material Specifications: The standard defines acceptable materials for grafts and patches, ensuring biocompatibility and durability.
• Performance Testing: Rigorous testing protocols are established to evaluate the mechanical properties and performance of vascular grafts under physiological conditions.
• Design Considerations: Guidelines for the design of vascular prostheses are provided, focusing on dimensions, wall thickness, and structural integrity.
• Labeling and Documentation: Clear labeling requirements are specified to ensure proper identification and traceability of the products.

Implementation Benefits

Adhering to BS EN ISO 7198:2017 offers numerous benefits for manufacturers and healthcare providers:

• Enhanced Safety: Compliance with the standard helps mitigate risks associated with vascular implants, ensuring patient safety during surgical procedures.
• Improved Quality: Following the outlined specifications promotes the production of high-quality vascular prostheses, leading to better patient outcomes.
• Market Access: Compliance with this standard is often a prerequisite for market entry in various regions, facilitating international trade.
• Regulatory Compliance: Meeting the requirements of BS EN ISO 7198:2017 aids in fulfilling regulatory obligations, streamlining the approval process for medical devices.

Compliance Value

For compliance professionals, understanding and implementing BS EN ISO 7198:2017 is crucial. The standard provides a framework that aligns with regulatory expectations, ensuring that products meet both safety and efficacy criteria. By integrating these standards into quality management systems, organisations can demonstrate their commitment to excellence and regulatory compliance.

Moreover, regular audits and assessments against the standard can identify areas for improvement, fostering a culture of continuous enhancement in product quality and safety. This proactive approach not only benefits manufacturers but also instills confidence in healthcare providers and patients alike.

In conclusion, BS EN ISO 7198:2017 serves as a vital resource for the development and implementation of vascular prostheses. Its comprehensive guidelines ensure that products are safe, effective, and compliant with international standards, ultimately contributing to improved patient care in cardiovascular procedures.