Health Care Technology Official British Standard

BS EN ISO 9360-2:2009

Ensure compliance with BS EN ISO 9360-2:2009 for HMEs, enhancing patient safety and effective humidification in respiratory care.

Overview

BS EN ISO 9360-2:2009 specifies the requirements for heat and moisture exchangers (HMEs) used in anaesthetic and respiratory equipment, specifically for humidifying respired gases in humans. This standard is particularly relevant for HMEs designed for tracheostomized patients with minimum tidal volumes of 250 ml. The standard aims to ensure that these devices provide effective humidification while maintaining patient safety and comfort.

Key Requirements

  • Performance Standards: HMEs must demonstrate adequate heat and moisture exchange efficiency under specified conditions.
  • Biocompatibility: Materials used in HMEs must be biocompatible to prevent adverse reactions in patients.
  • Design Specifications: The design must facilitate easy integration with existing respiratory equipment.
  • Testing Protocols: Comprehensive testing must be conducted to validate the performance claims of HMEs.

Implementation Benefits

Implementing BS EN ISO 9360-2:2009 provides several practical benefits for healthcare facilities:

  • Enhanced Patient Care: By ensuring effective humidification, HMEs contribute to better respiratory function and patient comfort.
  • Standardised Practices: Compliance with this standard promotes uniformity in the selection and use of HMEs across healthcare settings.
  • Risk Mitigation: Adhering to established standards reduces the risk of complications associated with inadequate humidification.

Compliance Value

Compliance with BS EN ISO 9360-2:2009 is essential for healthcare providers aiming to meet regulatory requirements and ensure patient safety. This standard aligns with international best practices, facilitating the safe use of HMEs in clinical settings. Additionally, demonstrating compliance can enhance the reputation of healthcare facilities, as it reflects a commitment to quality and patient care.

In summary, BS EN ISO 9360-2:2009 serves as a critical guideline for the design, testing, and implementation of HMEs for tracheostomized patients. By adhering to this standard, healthcare professionals can ensure that they are providing effective and safe respiratory support.

Technical Information

Health Care Technology
BSI Group
978 0 580 65026 0
Specification Details
  • Anaesthetic and respiratory equipment
  • Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
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