BS EN ISO 11608-2:2022
Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles Part 2: Needles
| Standard number: | BS EN ISO 11608-2:2022 |
| Pages: | 42 |
| Released: | 2022-07-15 |
| ISBN: | 978 0 539 01995 7 |
| Status: | Standard |
BS EN ISO 11608-2:2022 Needle-based Injection Systems for Medical Use
Requirements and Test Methods for Double-ended Pen Needles
Standard Number: BS EN ISO 11608-2:2022
Pages: 42
Released: 2022-07-15
ISBN: 978 0 539 01995 7
Name: Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles Part 2: Needles
Status: Standard
Overview
The BS EN ISO 11608-2:2022 standard is an essential document for professionals in the medical field, particularly those involved in the design, manufacturing, and quality assurance of needle-based injection systems. This standard provides comprehensive requirements and test methods specifically for double-ended pen needles, ensuring that these medical devices meet the highest safety and performance standards.
Key Features
- Comprehensive Coverage: Spanning 42 pages, this standard offers detailed guidelines and specifications for double-ended pen needles, covering all critical aspects from design to performance testing.
- Up-to-date Information: Released on July 15, 2022, this standard reflects the latest advancements and best practices in the field of needle-based injection systems.
- International Recognition: As part of the ISO 11608 series, this standard is recognized globally, ensuring that products adhering to it are accepted and trusted worldwide.
- ISBN: 978 0 539 01995 7, making it easy to reference and locate in libraries and databases.
Why This Standard is Important
Needle-based injection systems are critical in the administration of medications, particularly for patients requiring regular injections, such as those with diabetes. The double-ended pen needles covered in this standard are designed to ensure precise and safe delivery of medication, minimizing discomfort and risk of infection. Adhering to the BS EN ISO 11608-2:2022 standard ensures that these devices are reliable, effective, and safe for patient use.
Detailed Requirements and Test Methods
The standard outlines specific requirements for the design, materials, and performance of double-ended pen needles. It includes rigorous test methods to verify that these requirements are met, ensuring that each needle performs consistently and safely. Key areas covered include:
- Design Specifications: Detailed guidelines on the dimensions, materials, and construction of double-ended pen needles to ensure compatibility with various injection systems and patient needs.
- Performance Testing: Comprehensive test methods to evaluate the performance of the needles, including penetration force, flow rate, and durability.
- Safety Standards: Requirements to ensure that the needles are safe for use, including sterility, biocompatibility, and resistance to breakage.
- Quality Assurance: Guidelines for manufacturing processes and quality control to ensure that each needle meets the required standards consistently.
Who Should Use This Standard?
The BS EN ISO 11608-2:2022 standard is indispensable for a wide range of professionals in the medical device industry, including:
- Design Engineers: To ensure that new needle designs meet international safety and performance standards.
- Quality Assurance Teams: To implement rigorous testing and quality control processes that comply with the standard.
- Regulatory Affairs Specialists: To ensure that products meet regulatory requirements and are approved for use in various markets.
- Manufacturers: To produce high-quality, reliable double-ended pen needles that meet the needs of healthcare providers and patients.
Benefits of Compliance
Adhering to the BS EN ISO 11608-2:2022 standard offers numerous benefits, including:
- Enhanced Safety: Ensuring that needles are safe for patient use, reducing the risk of injury and infection.
- Improved Performance: Guaranteeing that needles perform consistently and effectively, providing reliable medication delivery.
- Regulatory Approval: Facilitating the approval process for new products in various markets, as compliance with international standards is often a prerequisite.
- Market Acceptance: Building trust with healthcare providers and patients by demonstrating a commitment to quality and safety.
Conclusion
The BS EN ISO 11608-2:2022 standard is a vital resource for anyone involved in the development, manufacturing, and regulation of needle-based injection systems. By providing detailed requirements and test methods for double-ended pen needles, this standard ensures that these critical medical devices meet the highest standards of safety and performance. Whether you are a design engineer, quality assurance professional, regulatory affairs specialist, or manufacturer, adhering to this standard is essential for delivering high-quality, reliable products that meet the needs of healthcare providers and patients worldwide.
BS EN ISO 11608-2:2022
This standard BS EN ISO 11608-2:2022 Needle-based injection systems for medical use. Requirements and test methods. Double-ended pen needles is classified in these ICS categories:
- 11.040.25 Syringes, needles and catheters