BS EN 13824:2004 - A Comprehensive Guide

The BS EN 13824:2004 standard provides essential guidelines and specifications for the sterilization of health care products, specifically focusing on the requirement for the sterile barrier systems. Published on December 6, 2004, this standard serves as a critical reference for ensuring the safety and efficacy of medical devices, particularly in maintaining sterile conditions during storage and transportation.

This British Standard is classified under the umbrella of Health Care Technology, making it an indispensable tool for manufacturers, quality assurance personnel, and regulatory bodies involved in the design and packaging of sterile medical products. With an ISBN of 0 580 44955 6 and priced at £306.00, the document is available in both PDF and hardcopy formats to cater to varying organizational needs.

Key Specifications

• Standard Number: BS EN 13824:2004
• Adoption: Identical to European Norm EN 13824:2004
• Publication Date: December 6, 2004
• Pages: 64

It is noteworthy that BS EN 13824:2004 has been replaced by the BS EN ISO 13408 series, which includes Parts 1 to 6. Transitioning to these newer standards, organizations must adhere to the latest guidelines to ensure compliance and maintain high-quality standards in their manufacturing processes.

Importance of Compliance

Compliance with BS EN 13824:2004 is vital for any organization involved in the healthcare sector. Adhering to these specifications allows organizations to:

• Minimize risks associated with contaminations in sterile medical devices.
• Enhance the confidence of health care professionals and patients in the sterility of medical products.
• Streamline regulatory approval processes by demonstrating adherence to established international standards.

Moreover, understanding and implementing the standards outlined in BS EN 13824:2004 can significantly contribute to improving overall operational efficiency while safeguarding public health. Organizations seeking to excel in the highly regulated healthcare environment will find this standard not only beneficial but crucial.

Purchase Information

To obtain your copy of BS EN 13824:2004, please visit our purchasing options for both PDF and hardcopy formats. Make informed decisions for your health care technology requirements today.