BS EN ISO 14708-3:2022
Implants for surgery. Active implantable medical devices Implantable neurostimulators
| Standard number: | BS EN ISO 14708-3:2022 |
| Pages: | 66 |
| Released: | 2022-08-15 |
| ISBN: | 978 0 580 88666 9 |
| Status: | Standard |
BS EN ISO 14708-3:2022 - Implants for Surgery. Active Implantable Medical Devices Implantable Neurostimulators
Standard Number: BS EN ISO 14708-3:2022
Pages: 66
Released: 2022-08-15
ISBN: 978 0 580 88666 9
Name: Implants for Surgery. Active Implantable Medical Devices Implantable Neurostimulators
Status: Standard
Overview
The BS EN ISO 14708-3:2022 standard is an essential document for professionals in the medical field, particularly those involved in the design, manufacture, and application of active implantable medical devices, specifically implantable neurostimulators. This comprehensive standard provides detailed guidelines and requirements to ensure the safety, reliability, and performance of these critical medical devices.
Key Features
- Comprehensive Coverage: Spanning 66 pages, this standard offers an in-depth look at the various aspects of implantable neurostimulators, from design and manufacturing to testing and clinical evaluation.
- Up-to-Date Information: Released on August 15, 2022, the BS EN ISO 14708-3:2022 standard incorporates the latest advancements and best practices in the field of active implantable medical devices.
- International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that devices meeting these guidelines are accepted in international markets.
- ISBN: 978 0 580 88666 9, ensuring easy reference and cataloging in libraries and databases.
Why Choose BS EN ISO 14708-3:2022?
Implantable neurostimulators are sophisticated devices that require stringent standards to ensure their efficacy and safety. The BS EN ISO 14708-3:2022 standard is designed to address these needs comprehensively. Here are some reasons why this standard is indispensable:
- Enhanced Patient Safety: By adhering to the guidelines set forth in this standard, manufacturers can significantly reduce the risk of device failure, ensuring better patient outcomes.
- Regulatory Compliance: Compliance with this standard helps manufacturers meet regulatory requirements in various regions, facilitating smoother market entry and approval processes.
- Quality Assurance: The standard provides a framework for quality assurance, helping manufacturers maintain high standards throughout the product lifecycle.
- Innovation and Development: By following the latest guidelines, manufacturers can stay at the forefront of technological advancements, driving innovation in the field of implantable neurostimulators.
Detailed Content
The BS EN ISO 14708-3:2022 standard covers a wide range of topics essential for the development and application of implantable neurostimulators. Some of the key areas include:
- Design and Manufacturing: Detailed requirements for the design and manufacturing processes to ensure the highest quality and reliability of the devices.
- Testing and Validation: Comprehensive guidelines for testing and validation to ensure the devices meet all necessary performance and safety criteria.
- Clinical Evaluation: Requirements for clinical evaluation to ensure the devices are safe and effective for patient use.
- Risk Management: Guidelines for risk management to identify and mitigate potential risks associated with the use of implantable neurostimulators.
- Documentation and Reporting: Requirements for documentation and reporting to ensure transparency and traceability throughout the product lifecycle.
Target Audience
This standard is invaluable for a wide range of professionals in the medical device industry, including:
- Medical Device Manufacturers: Companies involved in the design and production of implantable neurostimulators will find this standard essential for ensuring their products meet the highest standards of quality and safety.
- Regulatory Affairs Specialists: Professionals responsible for ensuring compliance with regulatory requirements will benefit from the detailed guidelines provided in this standard.
- Quality Assurance Managers: Those responsible for maintaining quality standards throughout the product lifecycle will find this standard an indispensable resource.
- Clinical Researchers: Researchers involved in the clinical evaluation of implantable neurostimulators will benefit from the comprehensive guidelines for clinical testing and validation.
- Healthcare Providers: Medical professionals who use implantable neurostimulators in their practice will gain a better understanding of the standards and requirements that ensure the safety and efficacy of these devices.
Conclusion
The BS EN ISO 14708-3:2022 standard is a critical resource for anyone involved in the development, manufacture, and application of implantable neurostimulators. By providing comprehensive guidelines and requirements, this standard ensures that these devices meet the highest standards of quality, safety, and performance. Whether you are a manufacturer, regulatory specialist, quality assurance manager, clinical researcher, or healthcare provider, this standard will help you achieve excellence in your field.
BS EN ISO 14708-3:2022
This standard BS EN ISO 14708-3:2022 Implants for surgery. Active implantable medical devices is classified in these ICS categories:
- 11.040.40 Implants for surgery, prosthetics and orthotics