BS EN ISO 20789:2019 Anaesthetic and Respiratory Equipment - Passive Humidifiers

Introducing the BS EN ISO 20789:2019, a comprehensive standard that sets the benchmark for anaesthetic and respiratory equipment, specifically focusing on passive humidifiers. This standard is an essential resource for professionals in the medical field, ensuring the highest quality and safety in the use of passive humidifiers.

Overview

Released on October 23, 2019, this standard is a crucial document for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and application of anaesthetic and respiratory equipment. With a total of 56 pages, it provides detailed guidelines and specifications that are vital for maintaining the efficacy and safety of passive humidifiers used in medical settings.

Key Features

• Standard Number: BS EN ISO 20789:2019
• ISBN: 978 0 539 03462 2
• Status: Standard

Why Choose BS EN ISO 20789:2019?

The BS EN ISO 20789:2019 standard is meticulously crafted to address the specific needs and challenges associated with passive humidifiers in anaesthetic and respiratory care. Here are some compelling reasons why this standard is indispensable:

• Comprehensive Guidelines: It provides a thorough framework for the design, testing, and performance of passive humidifiers, ensuring they meet the highest standards of safety and functionality.
• International Recognition: As an ISO standard, it is recognized globally, facilitating international trade and compliance across different regions.
• Enhanced Patient Safety: By adhering to this standard, healthcare providers can significantly reduce the risk of complications associated with inadequate humidification during respiratory therapy.
• Quality Assurance: Manufacturers can leverage this standard to enhance the quality and reliability of their products, thereby gaining a competitive edge in the market.

Applications

The BS EN ISO 20789:2019 standard is applicable to a wide range of settings and scenarios, including:

• Hospitals and Clinics: Ensuring that passive humidifiers used in these environments meet stringent safety and performance criteria.
• Medical Device Manufacturing: Guiding manufacturers in the development of high-quality passive humidifiers that comply with international standards.
• Regulatory Compliance: Assisting regulatory bodies in evaluating and approving passive humidifiers for use in healthcare settings.

Benefits of Compliance

Compliance with the BS EN ISO 20789:2019 standard offers numerous benefits, including:

• Improved Patient Outcomes: By ensuring optimal humidification, healthcare providers can enhance patient comfort and reduce the risk of respiratory complications.
• Operational Efficiency: Standardized equipment leads to more efficient operations, reducing downtime and maintenance costs.
• Market Access: Compliance with international standards opens up new markets and opportunities for manufacturers.

Conclusion

The BS EN ISO 20789:2019 standard is an invaluable resource for anyone involved in the field of anaesthetic and respiratory care. By providing clear and comprehensive guidelines, it ensures that passive humidifiers are safe, effective, and reliable. Whether you are a healthcare provider, manufacturer, or regulatory body, this standard is essential for maintaining the highest levels of quality and safety in respiratory therapy.

Invest in the BS EN ISO 20789:2019 standard today and ensure that your equipment meets the rigorous demands of modern healthcare environments.

BS EN ISO 20789:2019

This standard BS EN ISO 20789:2019 Anaesthetic and respiratory equipment. Passive humidifiers is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment

This document specifies requirements for so-called “cold bubble-through” or “cold pass-over” humidifying equipment, hereafter referred to as a passive humidifier. Figure 1 and Figure 2 illustrate these passive humidifiers .

NOTE 1 Passive humidifier humidification chambers are at room temperature so they have a lower humidification output than active humidifiers.

Figure 1 Cold pass-over passive humidifier

Figure 2 Cold bubble-through passive humidifier

This document is also applicable to those accessories intended by their manufacturer to be connected to a passive humidifier .

A passive humidifier integrated into another medical device is subject to the requirements of the standard of the other medical device.

EXAMPLE 1 The requirements in ISO 80601‑2‑69 ^{[ 4 ]} also apply to a passive humidifier integrated into an oxygen concentrator.

EXAMPLE 2

The requirements in ISO 80601‑2‑70 ^{[ 5 ]} also apply a passive humidifier integrated into sleep apnoea therapy equipment.

This document does not specify the requirements for active heated humidifiers, heated breathing tubes, or active heat and moisture exchangers (HMEs), the requirements for which are given in ISO 80601‑2‑74.

NOTE 2 ISO 5367 specifies other safety and performance requirements for breathing tubes.

This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture, the requirements for which are given in ISO 9360‑1 ^{[ 6 ]} and ISO 9360‑2 ^{[ 7 ]}.

This document is not applicable to nebulizers used for the delivery of liquids to patients, the requirements for which are given in ISO 27427 ^{[ 8 ]}.

This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.

This document has been prepared to support the essential principles of safety and performance of a passive humidifier and related accessories as medical devices in accordance with ISO 16142‑1:2016. Annex D maps the clauses and subclauses of this document with the essential principles of ISO 16142‑1:2016.