BS EN 868-7:2017

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-7:2017 is the essential standard for healthcare providers, medical device manufacturers, and packaging suppliers. This comprehensive specification outlines the requirements for packaging materials and systems used in the terminal sterilization of medical devices. By adhering to this standard, organizations can ensure the sterility, integrity, and safety of critical healthcare products throughout the supply chain and during use.

Key Features and Benefits:

• Sterility Assurance: Provides stringent guidelines for packaging materials and designs to maintain sterility during terminal sterilization processes, such as autoclaving, ethylene oxide, or radiation.
• Integrity Protection: Specifies performance requirements for packaging systems to withstand physical stresses, environmental conditions, and handling during storage, transportation, and use.
• Regulatory Compliance: Aligns with the essential requirements of the EU Medical Devices Regulation (MDR) 2017/745, ensuring medical devices meet the highest standards for safety and performance.
• Harmonized Standards: Identical to the international standard EN 868-7, facilitating global trade and acceptance of medical device packaging.
• Comprehensive Guidance: Covers a wide range of packaging materials, including paper, nonwoven fabrics, plastic films, and rigid containers, ensuring suitability for diverse medical device applications.

Ensuring Sterile, Safe, and Compliant Medical Devices

BS EN 868-7:2017 is an essential reference for healthcare professionals, medical device manufacturers, and packaging suppliers. By adhering to this standard, organizations can:

• Maintain the sterility of medical devices throughout the supply chain and during use, protecting patients from the risk of infection.
• Ensure the physical integrity of packaging systems, preventing damage and preserving the functionality of the enclosed medical devices.
• Demonstrate compliance with the EU Medical Devices Regulation (MDR) 2017/745, meeting the essential requirements for safety and performance.
• Facilitate global trade and acceptance of medical devices by aligning with the harmonized international standard EN 868-7.
• Optimize packaging design and selection, leveraging the comprehensive guidance on a wide range of materials and systems.

Comprehensive Specifications for Packaging Integrity and Sterility

BS EN 868-7:2017 covers a broad range of requirements for packaging materials and systems used in the terminal sterilization of medical devices. The standard addresses the following key aspects:

• Material Properties: Specifies the physical, chemical, and biological characteristics of packaging materials, including paper, nonwoven fabrics, plastic films, and rigid containers.
• Packaging Design: Outlines the design requirements for packaging systems, such as sealing, closure mechanisms, and labeling, to ensure sterility and integrity.
• Performance Testing: Defines the test methods and acceptance criteria for evaluating the ability of packaging systems to withstand physical stresses, environmental conditions, and handling during storage, transportation, and use.
• Sterilization Compatibility: Ensures the suitability of packaging materials and systems for use with various terminal sterilization processes, including autoclaving, ethylene oxide, and radiation.
• Quality Management: Provides guidance on the implementation of quality management systems to ensure consistent and reliable packaging performance.

By adhering to the comprehensive specifications outlined in BS EN 868-7:2017, healthcare providers, medical device manufacturers, and packaging suppliers can ensure the sterility, integrity, and safety of critical medical devices, ultimately contributing to improved patient outcomes and healthcare quality.