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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.10 Anaesthetic, respiratory and reanimation equipment>BS EN ISO 16628:2022 Anaesthetic and respiratory equipment. Tracheobronchial tubes
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immediate downloadReleased: 2022-07-21
BS EN ISO 16628:2022 Anaesthetic and respiratory equipment. Tracheobronchial tubes

BS EN ISO 16628:2022

Anaesthetic and respiratory equipment. Tracheobronchial tubes

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Standard number:BS EN ISO 16628:2022
Pages:26
Released:2022-07-21
ISBN:978 0 539 12256 5
Status:Standard
BS EN ISO 16628:2022 Anaesthetic and respiratory equipment. Tracheobronchial tubes

BS EN ISO 16628:2022 Anaesthetic and Respiratory Equipment. Tracheobronchial Tubes

Standard Number: BS EN ISO 16628:2022

Pages: 26

Released: 2022-07-21

ISBN: 978 0 539 12256 5

Name: Anaesthetic and Respiratory Equipment. Tracheobronchial Tubes

Status: Standard

Overview

Introducing the BS EN ISO 16628:2022, the definitive standard for anaesthetic and respiratory equipment, specifically focusing on tracheobronchial tubes. This comprehensive document is essential for professionals in the medical field, ensuring the highest quality and safety standards for tracheobronchial tubes used in anaesthesia and respiratory care.

Key Features

  • Comprehensive Coverage: Spanning 26 pages, this standard provides detailed guidelines and specifications for tracheobronchial tubes, ensuring thorough understanding and implementation.
  • Latest Release: Published on 21st July 2022, this standard reflects the most current practices and technological advancements in the field.
  • International Recognition: As an ISO standard, it is recognized and respected globally, making it a crucial document for international compliance and best practices.
  • ISBN: 978 0 539 12256 5, ensuring easy reference and cataloging in professional libraries and databases.

Why Choose BS EN ISO 16628:2022?

The BS EN ISO 16628:2022 standard is indispensable for healthcare providers, manufacturers, and regulatory bodies involved in the production and use of tracheobronchial tubes. Here’s why:

  • Enhanced Patient Safety: Adhering to this standard ensures that tracheobronchial tubes meet stringent safety and performance criteria, minimizing risks and enhancing patient outcomes.
  • Quality Assurance: This standard provides a benchmark for quality, helping manufacturers produce reliable and effective tracheobronchial tubes.
  • Regulatory Compliance: Compliance with this standard is often a requirement for regulatory approval, facilitating smoother market entry and acceptance.
  • Professional Credibility: Utilizing and referencing this standard demonstrates a commitment to excellence and adherence to internationally recognized best practices.

Detailed Content

The BS EN ISO 16628:2022 standard covers a wide range of topics essential for the proper design, manufacture, and use of tracheobronchial tubes. Key areas include:

  • Material Specifications: Detailed requirements for the materials used in tracheobronchial tubes to ensure biocompatibility and durability.
  • Design and Dimensions: Guidelines on the design and dimensional specifications to ensure proper fit and function.
  • Performance Requirements: Criteria for the performance of tracheobronchial tubes, including airflow resistance, strength, and flexibility.
  • Testing Methods: Standardized testing procedures to verify compliance with the specified requirements.
  • Marking and Labeling: Requirements for the proper marking and labeling of tracheobronchial tubes to ensure traceability and correct usage.

Who Should Use This Standard?

The BS EN ISO 16628:2022 standard is designed for a wide range of professionals and organizations, including:

  • Medical Device Manufacturers: Ensuring that tracheobronchial tubes meet the highest standards of quality and safety.
  • Healthcare Providers: Implementing best practices in the use of tracheobronchial tubes to enhance patient care.
  • Regulatory Bodies: Setting and enforcing standards for the approval and monitoring of tracheobronchial tubes.
  • Research and Development Teams: Innovating and improving tracheobronchial tube designs based on the latest standards.

Conclusion

The BS EN ISO 16628:2022 standard is a vital resource for anyone involved in the field of anaesthetic and respiratory equipment. By adhering to this standard, professionals can ensure the highest levels of safety, quality, and performance for tracheobronchial tubes, ultimately leading to better patient outcomes and enhanced professional credibility.

Stay ahead in your field by integrating the BS EN ISO 16628:2022 standard into your practices and ensuring that your tracheobronchial tubes meet the most rigorous international standards.

DESCRIPTION

BS EN ISO 16628:2022


This standard BS EN ISO 16628:2022 Anaesthetic and respiratory equipment. Tracheobronchial tubes is classified in these ICS categories:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment
This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document