BS EN ISO 14708-4:2022
Implants for surgery. Active implantable medical devices. Implantable infusion pump systems
| Standard number: | BS EN ISO 14708-4:2022 |
| Pages: | 70 |
| Released: | 2022-08-03 |
| ISBN: | 978 0 539 04468 3 |
| Status: | Standard |
BS EN ISO 14708-4:2022 - Implants for Surgery. Active Implantable Medical Devices. Implantable Infusion Pump Systems
Standard Number: BS EN ISO 14708-4:2022
Pages: 70
Released: 2022-08-03
ISBN: 978 0 539 04468 3
Name: Implants for Surgery. Active Implantable Medical Devices. Implantable Infusion Pump Systems
Status: Standard
Overview
The BS EN ISO 14708-4:2022 standard is a comprehensive guide for the design, testing, and performance of implantable infusion pump systems. These systems are critical in the medical field for delivering precise amounts of medication directly into a patient's body, ensuring optimal therapeutic outcomes. This standard is essential for manufacturers, healthcare providers, and regulatory bodies to ensure the safety, reliability, and effectiveness of these advanced medical devices.
Key Features
- Comprehensive Coverage: The standard spans 70 pages, providing detailed guidelines and requirements for the development and implementation of implantable infusion pump systems.
- Up-to-Date Information: Released on August 3, 2022, this standard reflects the latest advancements and best practices in the field of active implantable medical devices.
- Global Relevance: As an ISO standard, it is recognized and applicable worldwide, ensuring consistency and quality across different regions and healthcare systems.
- ISBN: 978 0 539 04468 3, ensuring easy reference and cataloging for libraries and institutions.
Importance of Implantable Infusion Pump Systems
Implantable infusion pump systems play a crucial role in modern medicine. They are used to deliver a variety of medications, including pain management drugs, chemotherapy agents, and insulin, directly into the patient's body. This targeted delivery system offers numerous benefits:
- Precision: These systems allow for precise control over the dosage and timing of medication delivery, which is critical for managing chronic conditions and ensuring patient safety.
- Convenience: Patients with implantable infusion pumps can maintain a higher quality of life, as they do not need to visit healthcare facilities as frequently for medication administration.
- Reduced Side Effects: By delivering medication directly to the target area, these systems can minimize systemic side effects and improve overall treatment efficacy.
Who Should Use This Standard?
The BS EN ISO 14708-4:2022 standard is designed for a wide range of stakeholders in the medical device industry, including:
- Manufacturers: To ensure their products meet the highest standards of safety and performance.
- Healthcare Providers: To understand the capabilities and limitations of these devices, ensuring they are used effectively in patient care.
- Regulatory Bodies: To establish guidelines and regulations that protect patient safety and promote innovation in medical technology.
- Researchers: To stay informed about the latest standards and advancements in the field of implantable medical devices.
Detailed Content
The standard covers a wide range of topics essential for the development and use of implantable infusion pump systems, including:
- Design Requirements: Specifications for the physical and functional design of the devices, ensuring they are safe and effective for long-term implantation.
- Testing Protocols: Detailed procedures for testing the performance, reliability, and safety of the devices under various conditions.
- Biocompatibility: Guidelines for ensuring that the materials used in the devices are compatible with human tissue and do not cause adverse reactions.
- Electrical Safety: Standards for the electrical components of the devices, ensuring they operate safely within the human body.
- Software Requirements: Specifications for the software used to control the devices, ensuring it is reliable and secure.
- Clinical Evaluation: Guidelines for conducting clinical trials and evaluations to demonstrate the safety and efficacy of the devices.
Benefits of Compliance
Adhering to the BS EN ISO 14708-4:2022 standard offers numerous benefits for manufacturers and healthcare providers:
- Enhanced Safety: By following the guidelines, manufacturers can ensure their devices are safe for long-term use in patients.
- Regulatory Approval: Compliance with the standard can facilitate the regulatory approval process, allowing devices to reach the market more quickly.
- Market Acceptance: Devices that meet the standard are more likely to be accepted by healthcare providers and patients, leading to increased adoption and use.
- Innovation: The standard encourages innovation by providing a clear framework for the development of new and improved devices.
Conclusion
The BS EN ISO 14708-4:2022 standard is an essential resource for anyone involved in the development, regulation, or use of implantable infusion pump systems. By providing comprehensive guidelines and requirements, it ensures that these critical medical devices are safe, effective, and reliable. Whether you are a manufacturer, healthcare provider, regulatory body, or researcher, this standard will help you stay at the forefront of medical technology and improve patient outcomes.
BS EN ISO 14708-4:2022
This standard BS EN ISO 14708-4:2022 Implants for surgery. Active implantable medical devices. is classified in these ICS categories:
- 11.040.40 Implants for surgery, prosthetics and orthotics