BS EN ISO 11608-4:2022
Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics
| Standard number: | BS EN ISO 11608-4:2022 |
| Pages: | 72 |
| Released: | 2022-07-21 |
| ISBN: | 978 0 539 03130 0 |
| Status: | Standard |
BS EN ISO 11608-4:2022 Needle-based Injection Systems for Medical Use
Standard Number: BS EN ISO 11608-4:2022
Pages: 72
Released: 2022-07-21
ISBN: 978 0 539 03130 0
Name: Needle-based injection systems for medical use. Requirements and test methods Needle-based injection systems containing electronics
Status: Standard
Overview
The BS EN ISO 11608-4:2022 standard is a comprehensive guide that sets forth the requirements and test methods for needle-based injection systems (NIS) containing electronics. This standard is essential for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of electronic needle-based injection systems.
Key Features
- Comprehensive Coverage: Spanning 72 pages, this standard provides an in-depth look at the requirements and test methods for electronic needle-based injection systems.
- Up-to-Date Information: Released on July 21, 2022, this standard reflects the latest advancements and best practices in the field.
- Global Recognition: As an ISO standard, it is recognized and respected worldwide, ensuring that products meeting these requirements are of the highest quality and safety.
- Detailed Requirements: The standard outlines specific requirements for the design, performance, and safety of electronic needle-based injection systems, ensuring they meet the highest standards of reliability and efficacy.
- Rigorous Test Methods: It includes detailed test methods to verify that products meet the specified requirements, providing a robust framework for quality assurance.
Why Choose BS EN ISO 11608-4:2022?
Choosing the BS EN ISO 11608-4:2022 standard ensures that your needle-based injection systems are designed and tested to the highest standards. This not only enhances the safety and efficacy of your products but also boosts their marketability and acceptance in the global market.
Enhanced Safety and Efficacy
By adhering to the stringent requirements and test methods outlined in this standard, manufacturers can ensure that their products are safe and effective for medical use. This is particularly important for electronic needle-based injection systems, where precision and reliability are critical.
Global Market Acceptance
As an internationally recognized standard, BS EN ISO 11608-4:2022 facilitates the acceptance of your products in markets around the world. Compliance with this standard demonstrates your commitment to quality and safety, making your products more attractive to healthcare providers and regulatory bodies.
Comprehensive Guidance
This standard provides detailed guidance on all aspects of electronic needle-based injection systems, from design and performance to safety and testing. This comprehensive approach ensures that all critical factors are considered, helping you to develop products that meet the highest standards of quality and reliability.
Who Should Use This Standard?
The BS EN ISO 11608-4:2022 standard is essential for a wide range of stakeholders in the medical device industry, including:
- Manufacturers: Ensure your products meet the highest standards of safety and efficacy.
- Healthcare Providers: Select products that are designed and tested to rigorous standards.
- Regulatory Bodies: Verify that products comply with international standards.
- Quality Assurance Professionals: Implement robust testing and quality control processes.
Conclusion
The BS EN ISO 11608-4:2022 standard is an invaluable resource for anyone involved in the design, production, and use of electronic needle-based injection systems. By providing comprehensive requirements and test methods, this standard ensures that products are safe, effective, and of the highest quality. Whether you are a manufacturer, healthcare provider, or regulatory body, adhering to this standard will help you achieve excellence in the field of medical injection systems.
BS EN ISO 11608-4:2022
This standard BS EN ISO 11608-4:2022 Needle-based injection systems for medical use. Requirements and test methods is classified in these ICS categories:
- 11.040.25 Syringes, needles and catheters