BS ISO 18193:2021 Cardiovascular Implants and Artificial Organs. Cannulae for Extracorporeal Circulation

Standard Number: BS ISO 18193:2021

Pages: 42

Released: 2021-08-16

ISBN: 978 0 539 12473 6

Status: Standard

Overview

The BS ISO 18193:2021 standard is a comprehensive guideline for the design, production, and application of cannulae used in extracorporeal circulation. This standard is essential for professionals in the field of cardiovascular implants and artificial organs, providing a robust framework to ensure the highest quality and safety standards are met.

Key Features

• Comprehensive Coverage: Spanning 42 pages, this standard offers detailed information on the specifications and requirements for cannulae used in extracorporeal circulation.
• Up-to-Date Information: Released on August 16, 2021, the BS ISO 18193:2021 standard incorporates the latest advancements and best practices in the field.
• Global Recognition: As an ISO standard, it is recognized and respected worldwide, ensuring that your products meet international quality and safety benchmarks.
• ISBN: 978 0 539 12473 6, making it easy to reference and locate in professional and academic settings.

Why Choose BS ISO 18193:2021?

The BS ISO 18193:2021 standard is indispensable for manufacturers, healthcare providers, and regulatory bodies involved in the development and use of cardiovascular implants and artificial organs. Here are some compelling reasons to adopt this standard:

• Enhanced Safety: By adhering to this standard, you ensure that the cannulae used in extracorporeal circulation meet stringent safety requirements, minimizing the risk of complications during medical procedures.
• Quality Assurance: The standard provides a clear set of guidelines for quality control, helping manufacturers produce reliable and effective medical devices.
• Regulatory Compliance: Compliance with BS ISO 18193:2021 can facilitate regulatory approval processes, as it demonstrates a commitment to high standards of safety and quality.
• Professional Credibility: Utilizing a globally recognized standard enhances your credibility and reputation in the medical field, fostering trust among healthcare providers and patients.

Detailed Content

The BS ISO 18193:2021 standard covers a wide range of topics essential for the development and application of cannulae in extracorporeal circulation. Some of the key areas include:

• Design Specifications: Detailed guidelines on the design and construction of cannulae to ensure optimal performance and safety.
• Material Requirements: Specifications for the materials used in the production of cannulae, focusing on biocompatibility and durability.
• Testing and Validation: Procedures for testing and validating the performance of cannulae, including mechanical and biological assessments.
• Sterilization and Packaging: Standards for the sterilization and packaging of cannulae to maintain sterility and prevent contamination.
• Labeling and Documentation: Requirements for labeling and documentation to ensure clear communication of product information and usage instructions.

Who Should Use This Standard?

The BS ISO 18193:2021 standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: Companies involved in the design and production of cardiovascular implants and artificial organs will find this standard invaluable for ensuring their products meet the highest quality and safety standards.
• Healthcare Providers: Medical professionals who use cannulae in extracorporeal circulation can rely on this standard to ensure they are using safe and effective devices.
• Regulatory Bodies: Organizations responsible for the approval and regulation of medical devices can use this standard as a benchmark for evaluating the safety and efficacy of cannulae.
• Researchers and Academics: Individuals involved in the study and development of cardiovascular implants and artificial organs can use this standard as a reference for best practices and current industry standards.

Conclusion

The BS ISO 18193:2021 standard is a vital resource for anyone involved in the field of cardiovascular implants and artificial organs. By providing comprehensive guidelines for the design, production, and application of cannulae used in extracorporeal circulation, this standard helps ensure the highest levels of safety, quality, and efficacy. Whether you are a manufacturer, healthcare provider, regulatory body, or researcher, adopting this standard will enhance your professional credibility and contribute to the advancement of medical technology.

BS ISO 18193:2021

This standard BS ISO 18193:2021 Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO₂R), and other extracorporeal circulation techniques. This standard does not apply to:

• introducers (e.g., guidewires) as addressed in ISO 11070 ,

• isolated organ perfusion cannulae, and

• intravascular catheters as addressed in ISO 10555-3 .