Standards Development

Scope

This document is applicable to the basic safety and essential performance of a nebulizing system, hereafter referred to as ME equipment or ME system, intended to alleviate the symptoms of patients by delivering an inhalational therapy to the respiratory tract of the patient. A Nebulizing system is intended for use in the home healthcare environment by lay operators as well as in professional healthcare facilities.

This document includes:

– nebulizing systems which can be powered by gas, (e.g., compressors, pipeline systems, cylinders);

– electrically powered nebulizing systems [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices]; and

– manually powered nebulizing systems.

This document includes nebulizing systems used during spontaneous breathing (e.g., handheld equipment applied via a mouthpiece) as well as systems which are included into a ventilatory breathing system of a ventilatory support equipment or ventilators for ventilator dependent patients.

This document includes nebulizing systems intended for use with adults, children, neonates and premature born. This document includes nebulizing systems intended for the supply of drugs within ventilatory breathing systems.

This document does not apply to drug-specific nebulizers or their components (e.g., metered dose inhalers, metered liquid inhalers, dry powder inhalers).

This document does not specify the requirements for respiratory humidifiers, the requirements for which are given in ISO 80601-2-74.

This document is also applicable to those accessories intended by their manufacturer to be connected to nebulizing systems, where the characteristics of those accessories can affect the basic safety or essential performance of the nebulizing systems.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Purpose

Inhalational therapy nebulizing systems are widely used to deliver drugs and vaccines in an aerosol form to humans through the respiratory system. Nebulizers are also used for diagnostic purposes using radioisotopes for lung challenge tests. These drugs can be in the form of a solution, suspension or emulsion. Aerosol inhalation is the preferred route of administration for some drugs. Some drugs are intended for treatment of systemic diseases and other drugs are intended to treat respiratory diseases. To achieve the intended treatment, aerosol particles have to be deposited in specific parts of the respiratory tract. Different size particles tend to deposit in different parts of the respiratory system; therefore, the performance profile and the intended use of the nebulizer are defined by the manufacturer and specified in the accompanying documentation.

The details of nebulizers (e.g., the test methods for aerosol output) aerosol output rate, and particle sizing are given in ISO 27427, Anaesthetic and respiratory equipment

— Nebulizing systems and components.

The document is intended to cover the basic safety and essential performance of complete nebulizing system, intended to alleviate the symptoms of patients by delivering an inhalational therapy to the respiratory tract of the patient. Nebulizing systems are intended for use in the home healthcare environment by lay operators as well as in professional healthcare facilities.

The objectives of this document are to ensure the electrical, pneumatic, mechanical safety as well as the biocompatibility of the materials of the components that come into contact with the human body and compatibility between the materials of the components and the dispensed liquid of:

— nebulizing systems which can be powered by gas (e.g., compressors, pipeline systems, cylinders);

— electrically powered nebulizing systems [e.g., spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices]; and

— manually powered nebulizing systems.