BS EN ISO 9713:2022 Neurosurgical Implants - Self-Closing Intracranial Aneurysm Clips

Standard Number: BS EN ISO 9713:2022

Pages: 18

Released: 2022-02-07

ISBN: 978 0 580 99610 8

Name: Neurosurgical Implants. Self-Closing Intracranial Aneurysm Clips

Status: Standard

Overview

The BS EN ISO 9713:2022 standard is a comprehensive guideline for the design, production, and testing of self-closing intracranial aneurysm clips. This standard is essential for manufacturers and healthcare professionals involved in neurosurgery, ensuring the highest level of safety and efficacy for these critical medical devices.

Key Features

• Comprehensive Guidelines: This standard provides detailed instructions on the design, materials, and testing procedures for self-closing intracranial aneurysm clips, ensuring they meet the highest safety and performance standards.
• International Standard: As an ISO standard, it is recognized and adopted globally, facilitating international trade and ensuring consistency in the quality of neurosurgical implants.
• Up-to-Date Information: Released on 2022-02-07, this standard incorporates the latest advancements and research in the field of neurosurgery, providing the most current guidelines for manufacturers and healthcare professionals.
• Detailed Specifications: With 18 pages of in-depth information, this standard covers all aspects of self-closing intracranial aneurysm clips, from design and materials to testing and performance requirements.

Benefits

Adhering to the BS EN ISO 9713:2022 standard offers numerous benefits for both manufacturers and healthcare providers:

• Enhanced Patient Safety: By following the stringent guidelines outlined in this standard, manufacturers can ensure that their products are safe and effective, reducing the risk of complications during and after surgery.
• Regulatory Compliance: Compliance with this international standard helps manufacturers meet regulatory requirements in various countries, facilitating market access and reducing the risk of legal issues.
• Improved Product Quality: The detailed specifications and testing procedures outlined in this standard help manufacturers produce high-quality neurosurgical implants that meet the needs of healthcare professionals and patients.
• Increased Trust: Healthcare providers can trust that products adhering to this standard are reliable and effective, enhancing their confidence in the devices they use during critical neurosurgical procedures.

Who Should Use This Standard?

The BS EN ISO 9713:2022 standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: Companies involved in the design and production of neurosurgical implants will find this standard invaluable for ensuring their products meet the highest safety and performance standards.
• Healthcare Providers: Neurosurgeons and other healthcare professionals can use this standard to evaluate the quality and safety of the intracranial aneurysm clips they use in their practice.
• Regulatory Authorities: Government agencies and regulatory bodies can use this standard as a benchmark for assessing the compliance of neurosurgical implants with international safety and performance requirements.
• Researchers and Academics: Individuals involved in medical research and education can use this standard as a reference for the latest guidelines and best practices in the field of neurosurgical implants.

Conclusion

The BS EN ISO 9713:2022 standard is an essential resource for anyone involved in the design, production, and use of self-closing intracranial aneurysm clips. By providing comprehensive guidelines and detailed specifications, this standard ensures that these critical medical devices meet the highest safety and performance standards, ultimately enhancing patient outcomes and advancing the field of neurosurgery.

BS EN ISO 9713:2022

This standard BS EN ISO 9713:2022 Neurosurgical implants. Self-closing intracranial aneurysm clips is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics