BS EN ISO 7197:2024 Neurosurgical Implants: Sterile, Single-Use Hydrocephalus Shunts

Introducing the BS EN ISO 7197:2024, the latest standard in neurosurgical implants, specifically designed for sterile, single-use hydrocephalus shunts. This comprehensive standard is an essential resource for professionals in the medical field, ensuring the highest quality and safety in the production and use of these critical medical devices.

Overview

The BS EN ISO 7197:2024 standard provides detailed guidelines and specifications for the design, production, and testing of sterile, single-use hydrocephalus shunts. These devices are crucial in the treatment of hydrocephalus, a condition characterized by an abnormal accumulation of cerebrospinal fluid (CSF) in the brain. By adhering to this standard, manufacturers can ensure that their products meet the rigorous safety and performance requirements necessary for effective patient care.

Key Features

• Standard Number: BS EN ISO 7197:2024
• Pages: 22
• Release Date: November 28, 2024
• ISBN: 978 0 539 19499 9
• Status: Standard

Importance of Compliance

Compliance with the BS EN ISO 7197:2024 standard is crucial for manufacturers and healthcare providers. It ensures that hydrocephalus shunts are produced to the highest standards of quality and safety, minimizing the risk of complications and improving patient outcomes. By following these guidelines, manufacturers can also enhance their credibility and reputation in the medical device industry.

Comprehensive Guidelines

This standard covers a wide range of topics, including:

• Material selection and biocompatibility
• Design and construction requirements
• Sterilization processes and validation
• Performance testing and quality assurance
• Labeling and packaging requirements

Each section is meticulously detailed to provide manufacturers with the necessary information to produce safe and effective hydrocephalus shunts.

Enhancing Patient Safety

Patient safety is at the forefront of the BS EN ISO 7197:2024 standard. By setting stringent requirements for the design and production of hydrocephalus shunts, this standard helps to reduce the risk of device failure and associated complications. This is particularly important in neurosurgical applications, where precision and reliability are paramount.

Global Relevance

The BS EN ISO 7197:2024 standard is recognized internationally, making it a valuable resource for manufacturers and healthcare providers around the world. By adhering to this standard, companies can ensure that their products are accepted in global markets, facilitating international trade and collaboration in the medical device industry.

Conclusion

The BS EN ISO 7197:2024 standard is an indispensable tool for anyone involved in the production or use of hydrocephalus shunts. Its comprehensive guidelines ensure that these critical medical devices are manufactured to the highest standards of quality and safety, ultimately enhancing patient care and outcomes. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is essential for ensuring the safe and effective treatment of hydrocephalus.

Stay ahead in the field of neurosurgical implants by integrating the BS EN ISO 7197:2024 standard into your practices. Ensure your products meet the highest standards and provide the best possible care for patients worldwide.

BS EN ISO 7197:2024

This standard BS EN ISO 7197:2024 Neurosurgical implants. Sterile, single-use hydrocephalus shunts is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document does not provide any recommendations on which type of valve is most suitable for any specific context of use. This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer. This document does not apply to active implants for the treatment of hydrocephalus.