BS ISO 10555-8:2024 Intravascular Catheters

Standard Number: BS ISO 10555-8:2024

Pages: 20

Released: 2024-08-19

ISBN: 978 0 539 25496 9

Name: Intravascular catheters. Sterile and single-use catheters Catheters for extracorporeal blood treatment

Status: Standard

Overview

The BS ISO 10555-8:2024 standard is a comprehensive guideline for the design, production, and usage of intravascular catheters, specifically those intended for extracorporeal blood treatment. This standard ensures that the catheters are sterile, single-use, and meet the highest quality and safety requirements.

Key Features

• Comprehensive Guidelines: This standard provides detailed instructions on the design and manufacturing processes to ensure the highest quality of intravascular catheters.
• Sterile and Single-Use: Ensures that the catheters are sterile and intended for single-use, minimizing the risk of infection and cross-contamination.
• Extracorporeal Blood Treatment: Specifically designed for use in procedures involving extracorporeal blood treatment, ensuring optimal performance and safety.
• International Standard: As an ISO standard, it is recognized and respected globally, ensuring compliance with international best practices.

Benefits

Adhering to the BS ISO 10555-8:2024 standard offers numerous benefits for healthcare providers and patients alike:

• Enhanced Safety: By following this standard, manufacturers can ensure that their catheters are safe for use, reducing the risk of complications during medical procedures.
• Quality Assurance: The standard provides a benchmark for quality, ensuring that all catheters meet stringent criteria before reaching the market.
• Global Recognition: Compliance with an ISO standard means that the product is recognized and trusted worldwide, facilitating international trade and usage.
• Patient Confidence: Patients can have greater confidence in the safety and efficacy of their medical treatments when products adhere to recognized standards.

Detailed Specifications

The BS ISO 10555-8:2024 standard covers various aspects of intravascular catheters, including:

• Design Requirements: Specifications for the physical design of the catheters to ensure they are fit for purpose.
• Material Specifications: Guidelines on the types of materials that can be used in the production of the catheters to ensure biocompatibility and safety.
• Sterilization Processes: Detailed instructions on the sterilization methods to be used to ensure the catheters are free from contaminants.
• Packaging and Labeling: Requirements for the packaging and labeling of the catheters to ensure they are properly identified and protected until use.
• Performance Testing: Criteria for testing the performance of the catheters to ensure they meet the necessary standards for use in medical procedures.

Who Should Use This Standard?

The BS ISO 10555-8:2024 standard is essential for a wide range of stakeholders in the healthcare industry, including:

• Medical Device Manufacturers: Companies involved in the design and production of intravascular catheters will find this standard invaluable for ensuring their products meet the highest quality and safety standards.
• Healthcare Providers: Hospitals, clinics, and other healthcare facilities can use this standard to ensure they are using safe and effective catheters for extracorporeal blood treatment.
• Regulatory Bodies: Organizations responsible for the regulation and approval of medical devices can use this standard as a benchmark for evaluating the safety and efficacy of intravascular catheters.
• Quality Assurance Professionals: Individuals responsible for quality control and assurance in the production of medical devices will find this standard essential for maintaining high standards.

Conclusion

The BS ISO 10555-8:2024 standard is a critical resource for ensuring the safety, quality, and efficacy of intravascular catheters used in extracorporeal blood treatment. By adhering to this standard, manufacturers can produce reliable and safe catheters, healthcare providers can offer better patient care, and regulatory bodies can ensure compliance with international best practices. This standard is a testament to the ongoing commitment to improving medical device quality and patient safety worldwide.

BS ISO 10555-8:2024

This standard BS ISO 10555-8:2024 Intravascular catheters. Sterile and single-use catheters is classified in these ICS categories:

• 11.040.25 Syringes, needles and catheters
• 11.040.25 Syringes, needles and catheters