ISO 80601-2-79-2024 PDF

Full title and description

St ISO 80601-2-79-2024 — Medical electrical equipment — Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment. This standard specifies requirements for the safety and essential performance of ventilatory support equipment and associated accessories intended for use by lay operators in the home healthcare environment and in professional health care facilities, for patients with ventilatory impairment (not intended for patients fully dependent on immediate life support).

Abstract

This document sets out particular requirements that supplement the general requirements of the IEC/ISO 60601 series to address hazards, essential performance, testing and labeling specific to ventilatory support equipment for ventilatory impairment. It covers equipment and accessories whose characteristics can affect safety or performance (for example breathing sets, humidifiers, filters and external power sources) and clarifies intended use, user profile (including lay operators) and environment (including home healthcare).

General information

• Status: Published / Current international standard.
• Publication date: 28 August 2024.
• Publisher: ISO/IEC technical publications (TC 62/SC 62D).
• ICS / categories: 11.040.10 (Medical equipment — Respiratory therapy equipment).
• Edition / version: Edition 2.0 (2024).
• Number of pages: 107 pages.

Scope

The standard applies to ventilatory support equipment intended for ventilatory impairment — equipment intended for use in the home healthcare environment and by lay operators, and to accessories intended by the manufacturer to be connected to the breathing system when those accessories can affect basic safety or essential performance. It excludes ventilators for critical care, anaesthetic applications, ventilator-dependent patients in the home environment addressed by other parts of the series, and several specialized ventilatory devices.

Key topics and requirements

• Requirements for basic safety and essential performance specific to ventilatory support for ventilatory impairment (including alarm, control and failure modes).
• Design and testing of breathing systems and accessories that influence safety or performance (sensors, humidifiers, water traps, expiratory valves, filters, connectors).
• Risk management and labeling requirements for home use and lay operators, including guidance on unreliable mains supply in home environments.
• Verification and validation tests for primary operating functions and essential performance under foreseeable use conditions.
• Clarifications on intended patient population (ventilatory impairment, not immediate life-support ventilator-dependent patients) and excluded applications.

Typical use and users

Primary users are manufacturers and designers of ventilatory support equipment and accessories, testing and certification laboratories, regulatory bodies and conformity assessment organizations, clinical engineers, and healthcare providers (including home healthcare suppliers). The standard is used to guide product design, pre-market compliance testing, technical documentation and post-market surveillance for devices intended for lay and professional use.

Related standards

This part is one of the ISO/IEC 80601 series of particular standards that supplement IEC 60601-1 general requirements. Closely related parts include ISO 80601-2-80 (ventilatory support equipment for ventilatory insufficiency) and other ventilator- and respiratory-related parts (for critical care, anaesthesia, sleep apnoea therapy, etc.). The 2018 first edition of ISO 80601-2-79 was withdrawn and replaced by this 2024 edition.

Keywords

ventilatory support equipment; ventilatory impairment; home healthcare; lay operator; basic safety; essential performance; breathing system; accessories; alarms; IEC/ISO 80601 series.

FAQ

Q: What is this standard?

A: An international standard (ISO 80601-2-79:2024) specifying particular requirements for the basic safety and essential performance of ventilatory support equipment intended for ventilatory impairment.

Q: What does it cover?

A: It covers device requirements, testing, labeling and risk considerations for ventilatory support equipment and accessories used by lay operators and in home healthcare, including items that can affect basic safety or essential performance (breathing sets, humidifiers, filters, power sources, alarms, etc.).

Q: Who typically uses it?

A: Device manufacturers, conformity assessment bodies, test laboratories, regulators, clinical engineers and healthcare providers involved in design, certification and safe deployment of ventilatory support equipment for non–life‑dependent patients.

Q: Is it current or superseded?

A: Current — this 2024 edition (Edition 2.0) replaces the 2018 edition of ISO 80601-2-79. The 2018 edition was withdrawn on publication of the 2024 edition.

Q: Is it part of a series?

A: Yes — it is part of the ISO/IEC 80601 series (particular requirements for medical electrical equipment) which works alongside IEC 60601-1 general requirements; related parts address other ventilator types and respiratory therapy equipment.

Q: What are the key keywords?

A: Ventilatory support, ventilatory impairment, home healthcare, lay operator, essential performance, breathing system, accessories, alarms, IEC/ISO 80601.