ISO 80601-2-74-2021 PDF

Full title and description

St ISO 80601-2-74:2021 — Medical electrical equipment — Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment. This international standard specifies safety and performance requirements for electrical humidification devices (humidifiers) and their accessories when used in clinical respiratory therapies, and for ME systems incorporating humidification functions.

Abstract

ISO 80601-2-74:2021 defines requirements to ensure the basic safety and essential performance of respiratory humidifying equipment (humidifiers) and associated accessories that may affect humidifier performance. It covers active humidifiers (including heated humidifiers and active heat-and-moisture-exchangers), heated breathing tubes and controllers, and a range of clinical uses such as invasive and non-invasive ventilation, nasal high-flow therapy, obstructive sleep apnoea therapy and humidification for tracheostomy patients. The document also clarifies exclusions (for example, passive HMEs covered by ISO 9360 series and cold pass-over/bubble-through devices covered by ISO 20789) and sets the humidifier requirements in the context of the general medical electrical equipment standard IEC 60601-1.

General information

• Status: Published
• Publication date: 13 July 2021 (2021-07)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment)
• Edition / version: Edition 2 (2021)
• Number of pages: 99 (international edition)

Scope

The standard applies to the basic safety and essential performance of humidifiers (ME equipment) and ME systems that include humidification, together with accessories intended by the manufacturer to be connected to a humidifier when those accessories can influence safety or performance. It includes requirements for active HMEs and heated breathing tubes and addresses humidification use-cases across invasive ventilation, non‑invasive ventilation, nasal high-flow therapy, obstructive sleep apnoea therapy and tracheostomy care. Excluded are passive HMEs (covered by ISO 9360 series), cold pass-over or cold bubble-through humidifiers (covered by ISO 20789), room/HVAC humidifiers, humidifiers incorporated into infant incubators, and nebulizers used for drug delivery.

Key topics and requirements

• Requirements for basic safety and essential performance of ME humidifiers and ME humidification systems.
• Applicability to accessories that affect humidifier performance (for example heated-wire breathing tubes and controllers).
• Performance expectations for different clinical uses: invasive ventilation, non-invasive ventilation, nasal high-flow therapy, obstructive sleep apnoea therapy, tracheostomy humidification.
• Requirements and tests for humidity and temperature control, stability and accuracy of delivered gas conditions.
• Electrical, mechanical and thermal safety in accordance with the general medical electrical equipment standard (IEC 60601-1) and relevant collateral standards.
• Alarms, indicators and safety interlocks related to temperature, flow, humidification faults and disconnection.
• Risk management, labeling, instructions for use, maintenance and cleaning/disinfection guidance.
• Requirements covering active HMEs and differentiation from passive HMEs and other humidification technologies.
• Test methods, verification procedures and performance documentation required for conformity assessment.

Typical use and users

This standard is used by manufacturers and designers of respiratory humidifiers and ventilator OEMs that integrate humidification functions, medical device test laboratories, clinical engineers, quality and regulatory affairs professionals, notified bodies and conformity-assessment organizations, and healthcare procurement teams seeking to verify device compliance with international safety and performance expectations.

Related standards

Commonly referenced and related standards include IEC 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment), ISO 9360 series (passive heat and moisture exchangers), ISO 20789 (passive/cold humidifiers), ISO 5367 (breathing sets and breathing tubes), and other parts of the ISO 80601-2 series addressing specific respiratory and ventilatory equipment (for example ISO 80601-2-12, ISO 80601-2-70, ISO 80601-2-72, ISO 80601-2-79, ISO 80601-2-80 and ISO 80601-2-90). National adoptions and harmonized versions (EN/ISO, CSA, etc.) may also exist.

Keywords

respiratory humidifier, humidifying equipment, heated breathing tube, active HME, medical electrical equipment, humidification, ventilator accessory, IEC 60601-1, respiratory therapy, essential performance

FAQ

Q: What is this standard?

A: ISO 80601-2-74:2021 is an international standard that specifies particular requirements for the basic safety and essential performance of respiratory humidifying equipment and related accessories used in clinical respiratory therapies.

Q: What does it cover?

A: It covers active humidifiers (including heated humidifiers and active HMEs), heated breathing tubes and controllers, performance and safety requirements for delivering controlled humidity and temperature to patients, alarm and indicator requirements, risk management, labeling, and test methods for verification. It also states what devices and humidification technologies are excluded.

Q: Who typically uses it?

A: Device manufacturers, design engineers, test laboratories, conformity assessment bodies, regulatory and quality professionals, clinical engineers and healthcare procurement specialists use the standard to design, test, certify and procure compliant humidification equipment.

Q: Is it current or superseded?

A: This is the second edition published in July 2021; it replaced the earlier 2017 edition. As published in July 2021, it is the current ISO edition; interested parties should check national or ISO catalogues for any subsequent revisions or confirmations.

Q: Is it part of a series?

A: Yes. ISO 80601 is a multipart series of standards that specifies particular requirements for different types of medical electrical equipment (each “Part 2‑xx” addresses a specific device type). ISO 80601-2-74 is the part addressing respiratory humidifying equipment and references other parts where humidifiers are integrated into other devices.

Q: What are the key keywords?

A: Respiratory humidifier, humidifying equipment, heated breathing tube, active HME, medical electrical equipment, ventilator accessory, humidity control, IEC 60601-1.