BS EN 868-10:2018

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-10:2018 is the essential standard for packaging of terminally sterilized medical devices. This British Standard provides detailed requirements and test methods to ensure the sterility and integrity of packaged medical products throughout their lifecycle, from manufacturing to end-use.

Ensuring Sterility and Compliance

Compliance with BS EN 868-10:2018 is crucial for medical device manufacturers and healthcare providers. This standard specifies the necessary properties and performance criteria for packaging materials, designs, and systems to:

• Maintain sterility of the packaged medical device during storage, transportation, and handling
• Provide adequate protection against physical damage, microbial contamination, and environmental factors
• Enable effective sterilization processes and maintain sterility assurance levels (SAL)
• Facilitate aseptic presentation and easy access to the sterile contents

Comprehensive Requirements and Test Methods

BS EN 868-10:2018 covers a wide range of technical specifications and test procedures for medical device packaging, including:

• Materials: Requirements for physical, chemical, and biological properties of packaging materials, such as paper, plastic films, and nonwoven fabrics
• Design: Criteria for package design, including dimensions, sealing, and closure mechanisms
• Integrity: Test methods to evaluate package integrity, including seal strength, microbial barrier properties, and resistance to physical stress
• Sterilization: Compatibility with various sterilization methods, such as ethylene oxide, gamma radiation, and steam
• Labeling: Specifications for package labeling, including mandatory information and symbols

Benefits of Compliance

Compliance with BS EN 868-10:2018 offers several key benefits for medical device manufacturers and healthcare providers:

• Sterility Assurance: Ensures the sterility of packaged medical devices throughout their entire lifecycle, reducing the risk of healthcare-associated infections (HAIs)
• Regulatory Compliance: Meets the essential requirements of the EU Medical Device Regulation (MDR) and other relevant directives, enabling market access and patient safety
• Quality Assurance: Provides a comprehensive framework for quality control and validation of medical device packaging systems
• Operational Efficiency: Facilitates efficient handling, storage, and distribution of sterile medical devices, minimizing waste and downtime

By adhering to the rigorous standards set forth in BS EN 868-10:2018, medical device manufacturers and healthcare providers can ensure the safety, quality, and compliance of their sterile medical products, ultimately contributing to better patient outcomes and healthcare delivery.