Standards Development

Scope

Terminology, definitions, semantics and their rationale for high-frequency ventilators as defined in ISO 80601-2-87:2021, Medical electrical equipment—Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators.

These devices include those

• capable of providing more than 150 inflations/min..

There are three principal designations of HFV:

• — high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];

• — high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and

• — high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase.

Purpose

In the Form 04 for ISO 80601-2-87, ISO/TC121/SC3/N2251, dated 13 September 2017, it was stated that “high frequency ventilation is already a highly-used mode of critical care ventilation in intensive care units throughout the world, and this is especially true in neonatal applications. In Japan, for example, depending on the birth weight of the neonate, high-frequency ventilation can be used in a majority of cases that involve mechanical ventilation and is often used as the initial ventilation mode applied to the patient.”

The New Work Item Proposal referenced above justifies the project as follows: “High-frequency ventilation has been in the marketplace since the mid 1980’s, and there are several manufacturers of these ventilators already in the marketplace. Although the basic settings, monitored parameters, and alarms of high-frequency ventilation are similar across various devices, as there is no current international standard for high frequency ventilation, there are various differences in the interpretation and implementation of these parameters. Because manufacturers use similar naming conventions for these parameters, there is a belief in the clinical theater that all of these devices are measuring the same thing in the same way, which is not true. Further, in order to prevent unnecessary confusion and to ensure basic safety and essential performance, the basic settings, monitored parameters, and basic alarm requirements for high frequency ventilators should be standardized.

The purpose of this standard will be to define the minimum basic requirements for the settings, performance and alarm systems for high frequency ventilators, as well as to standardize the algorithms for monitored values, or at least require manufacturers to document these algorithms.” In parallel, ISO 19223:2019, Lung ventilators and related equipment, vocabulary and semantics does not adequately address the particular terminology, semantics, setting parameters and other aspects for high-frequency ventilators.

ISO/TC121/SC4 seeks to establish a new Working Group, ISO/TC121/SC4/WG2 to develop a new International Standard as ISO 19223, Lung ventilators and related equipment, Part 2, High-frequency ventilators, Vocabulary and semantics