BS EN ISO 11608-1:2015

Comprehensive Standard for Pen-Injectors in Medical Applications

BS EN ISO 11608-1:2015 is the essential standard for pen-injectors used in the healthcare industry. This comprehensive document outlines the requirements and test methods for the design, construction, and performance of these critical medical devices. Compliance with this standard ensures the safety, quality, and reliability of pen-injectors, enabling healthcare professionals to deliver essential treatments with confidence.

Ensuring Safety and Efficacy

Pen-injectors play a vital role in the administration of various medications, from insulin for diabetes management to hormone therapies and beyond. BS EN ISO 11608-1:2015 sets forth stringent requirements to safeguard patients and healthcare workers, including:

• Design Specifications: The standard specifies design criteria for pen-injectors, covering aspects such as dose accuracy, dose delivery, and user interface to optimize safety and ease of use.
• Material Requirements: Guidelines on the selection and testing of materials used in pen-injector construction, ensuring biocompatibility and compatibility with the intended medication.
• Performance Testing: Comprehensive test methods to evaluate the mechanical, electrical, and functional performance of pen-injectors, verifying their reliability and consistency under real-world conditions.

Compliance with International Regulations

This British Standard is fully aligned with the latest ISO 11608-1:2014 standard, ensuring global harmonization and facilitating international trade and market access for medical device manufacturers. By adhering to BS EN ISO 11608-1:2015, organizations can demonstrate compliance with the essential requirements of the following regulations:

• Medical Device Directive (MDD) 93/42/EEC: Fulfilling the essential safety and performance requirements for medical devices within the European Union.
• FDA Quality System Regulation (21 CFR Part 820): Aligning with the quality management system requirements for medical devices in the United States.
• ISO 13485:2016: Satisfying the quality management system standard for medical devices, recognized worldwide.

Comprehensive Guidance for Pen-Injector Design and Manufacture

BS EN ISO 11608-1:2015 provides a robust framework for the design, development, and production of pen-injectors, covering a wide range of technical specifications and test methods, including:

• Dimensional Requirements: Guidelines on the size, shape, and ergonomics of pen-injectors to ensure user comfort and ease of handling.
• Dose Accuracy and Delivery: Precise requirements for the accuracy and consistency of dose delivery, ensuring patients receive the intended medication amount.
• Mechanical and Electrical Safety: Test methods to evaluate the structural integrity, durability, and electrical safety of pen-injectors, protecting users from potential hazards.
• Labeling and Packaging: Specifications for the clear and comprehensive labeling of pen-injectors, as well as packaging requirements to maintain product integrity during storage and transportation.

By adhering to the comprehensive requirements outlined in BS EN ISO 11608-1:2015, medical device manufacturers can develop high-quality, safe, and compliant pen-injectors that meet the evolving needs of healthcare professionals and patients worldwide.