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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 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications
immediate downloadReleased: 2024-08-28
BS EN ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications

BS EN ISO 80369-2:2024

Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications

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Standard number:BS EN ISO 80369-2:2024
Pages:68
Released:2024-08-28
ISBN:978 0 539 13732 3
Status:Standard
BS EN ISO 80369-2:2024 - Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications

BS EN ISO 80369-2:2024 - Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications

Standard Number: BS EN ISO 80369-2:2024

Pages: 68

Released: 2024-08-28

ISBN: 978 0 539 13732 3

Name: Small-bore connectors for liquids and gases in healthcare applications Connectors for respiratory applications

Status: Standard

Overview

The BS EN ISO 80369-2:2024 standard is an essential document for healthcare professionals and manufacturers involved in the design, production, and use of small-bore connectors for respiratory applications. This comprehensive standard ensures the safety and compatibility of connectors used for liquids and gases in healthcare settings, thereby minimizing the risk of misconnections and enhancing patient safety.

Key Features

  • Comprehensive Coverage: Spanning 68 pages, this standard provides detailed guidelines and specifications for small-bore connectors used in respiratory applications.
  • Latest Release: Released on August 28, 2024, this standard reflects the most current practices and technological advancements in the field.
  • Global Recognition: As an ISO standard, it is recognized and adopted worldwide, ensuring uniformity and consistency in healthcare practices across different regions.
  • Enhanced Safety: By adhering to this standard, healthcare providers can significantly reduce the risk of misconnections, which can lead to serious patient harm.
  • ISBN: The unique ISBN 978 0 539 13732 3 ensures easy reference and cataloging for libraries and institutions.

Why This Standard is Important

In the complex environment of healthcare, the use of small-bore connectors is widespread, particularly in respiratory applications. These connectors are critical components in various medical devices and systems, including ventilators, oxygen delivery systems, and nebulizers. The BS EN ISO 80369-2:2024 standard provides a unified framework that ensures these connectors are designed and manufactured to the highest safety and performance standards.

Misconnections, where a connector is unintentionally connected to an incompatible device, can have catastrophic consequences. This standard addresses this issue by specifying dimensions and performance requirements that prevent such errors. By following the guidelines set forth in this standard, manufacturers can produce connectors that are not only safe but also compatible with a wide range of medical devices.

Who Should Use This Standard

This standard is indispensable for a variety of stakeholders in the healthcare industry, including:

  • Manufacturers: Companies involved in the production of medical devices and connectors will find this standard crucial for ensuring their products meet international safety and performance criteria.Healthcare Providers: Hospitals, clinics, and other healthcare facilities can use this standard to guide their procurement and usage of small-bore connectors, ensuring patient safety and compliance with best practices.
  • Regulatory Bodies: Organizations responsible for the oversight and regulation of medical devices can use this standard as a benchmark for evaluating the safety and efficacy of small-bore connectors.
  • Researchers and Academics: Individuals involved in the study and development of medical device technology will find this standard a valuable resource for understanding current industry standards and practices.

Detailed Content

The BS EN ISO 80369-2:2024 standard is meticulously structured to cover all aspects of small-bore connectors for respiratory applications. Key sections include:

  • Scope and Field of Application: Defines the range of connectors covered by the standard and their intended use in healthcare settings.
  • Normative References: Lists other relevant standards and documents that are referenced within the text.
  • Terms and Definitions: Provides clear definitions of key terms used throughout the standard, ensuring a common understanding among users.
  • General Requirements: Outlines the fundamental requirements for the design, materials, and performance of small-bore connectors.
  • Dimensional Requirements: Specifies the exact dimensions and tolerances for connectors to ensure compatibility and prevent misconnections.
  • Performance Requirements: Details the performance criteria that connectors must meet, including tests for leakage, mechanical strength, and durability.
  • Test Methods: Describes the procedures for testing connectors to verify their compliance with the standard's requirements.
  • Marking and Labeling: Provides guidelines for the proper marking and labeling of connectors to ensure clear identification and traceability.

Conclusion

The BS EN ISO 80369-2:2024 standard is a vital resource for ensuring the safety and reliability of small-bore connectors used in respiratory applications. By adhering to this standard, manufacturers and healthcare providers can significantly reduce the risk of misconnections, thereby enhancing patient safety and improving overall healthcare outcomes. With its comprehensive coverage and detailed guidelines, this standard is an indispensable tool for anyone involved in the design, production, and use of small-bore connectors in the healthcare industry.

DESCRIPTION

BS EN ISO 80369-2:2024


This standard BS EN ISO 80369-2:2024 Small-bore connectors for liquids and gases in healthcare applications is classified in these ICS categories:
  • 11.040.10 Anaesthetic, respiratory and reanimation equipment
  • 11.040.20 Transfusion, infusion and injection equipment
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing). NOTE 1        The pressure is related to pressure available at the source to which the medical device is connected. NOTE 2        The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTE 3        Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards. NOTE 4        If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.