BS EN 868-2:2017

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-2:2017 is the essential standard for packaging of terminally sterilized medical devices. This British Standard provides detailed requirements and test methods for the materials, design, and performance of packaging systems to ensure the sterility of medical products throughout their shelf life.

Developed by the European Committee for Standardization (CEN), this standard is a crucial reference for medical device manufacturers, healthcare providers, and regulatory bodies. Compliance with BS EN 868-2:2017 is essential for ensuring patient safety and meeting stringent industry regulations.

Key Features and Benefits

Comprehensive Packaging Requirements

• Specifies materials, construction, and design criteria for medical device packaging
• Includes test methods to verify the performance and integrity of packaging systems
• Ensures the sterility of medical devices is maintained from manufacturing to point-of-use

Compliance and Regulatory Alignment

• Harmonized with the essential requirements of the EU Medical Devices Regulation (MDR 2017/745)
• Supports compliance with quality management systems such as ISO 13485
• Accepted by regulatory authorities worldwide for market access and product approvals

Improved Patient Safety

• Ensures the sterility of medical devices is maintained throughout their lifecycle
• Minimizes the risk of healthcare-associated infections (HAIs) and other complications
• Enhances the confidence of healthcare professionals and patients in the safety of medical products

Comprehensive Guidance for Medical Device Manufacturers

BS EN 868-2:2017 provides detailed technical specifications and test methods covering all aspects of medical device packaging, including:

• Material Requirements: Specifications for the physical, chemical, and microbiological properties of packaging materials, such as paper, nonwoven fabrics, plastic films, and rigid containers.
• Design Criteria: Guidelines for the design, construction, and sealing of packaging systems to ensure the maintenance of sterility.
• Performance Testing: Standardized test methods to evaluate the integrity, strength, and barrier properties of packaging, including seal strength, microbial barrier, and package integrity tests.
• Shelf-life Validation: Procedures for validating the shelf life of packaged medical devices, including accelerated aging tests and real-time studies.

By adhering to the comprehensive requirements of BS EN 868-2:2017, medical device manufacturers can ensure their packaging systems effectively protect the sterility of their products, ultimately safeguarding patient health and safety.