BS EN ISO 8871-1:2004 - Comprehensive Guide

The BS EN ISO 8871-1:2004 is a pivotal standard in the realm of health care technology, specifically focusing on the requirements of elastomeric materials used in medical devices. This standard outlines the specifications for the performance characteristics of elastomers, ensuring safety and efficacy in various applications.

As an identical adoption of ISO 8871-1:2003, this British Standard provides critical guidelines and detailed insights into the testing methods and quality assurance practices necessary for elastomers employed in healthcare settings. The document encompasses essential data that manufacturers, quality control personnel, and regulatory bodies need to uphold high standards in medical device production.

Key features of BS EN ISO 8871-1:2004 include:

• Material Quality: It establishes the properties required for elastomeric components to ensure compatibility with various fluids and medical applications.
• Performance Testing: It delineates the testing methodologies to assess key attributes, including tensile strength, elongation, and resistance to aging.
• Compliance Guidelines: The standard aids manufacturers in demonstrating compliance with regulatory requirements, promoting safety and reliability in patient care.
• International Relevance: As an internationally recognized standard, it facilitates global trade and interoperability, allowing for smoother regulatory pathways across different regions.

The adoption of BS EN ISO 8871-1:2004 is crucial for any organization involved in the design, development, and production of medical devices that incorporate elastomeric materials. By adhering to this standard, companies can enhance product quality, ensure regulatory compliance, and ultimately provide safer healthcare solutions.

Available in both PDF and hardcopy formats, the standard is priced at £220.00, making it a valuable investment for businesses committed to excellence in health care technology. With the latest review date of September 8, 2004, this document remains an essential reference point for the industry.

In conclusion, BS EN ISO 8871-1:2004 serves as a foundational text for organizations striving to meet the stringent demands of the healthcare market. Equip your team with the knowledge and standards necessary to excel in today's regulatory environment and elevate the quality of medical devices.