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Scope

1.1 The requirements given in Clause 1 of the General Standard apply with the following additions and modifications:

1.1.1 Replace with the following:

1.1.1.1 This specification includes requirements for the safety and performance of active vaporizing and nebulizing humidification systems, as defined in 3.1.6, suitable for inclusion in breathing systems (both intubated and non-intubated patients).

1.1.1.2 This specification also includes requirements for breathing tubes, including heated breathing tubes (heated-wire breathing circuits), and devices intended to control these heated breathing tubes, heated breathing tube controllers.

1.1.1.3 Heat and moisture exchangers (HMEs) are outside the scope of this specification. However, it is recognized that their safety and performance may affect that of humidification systems. Numerous studies have been published citing the benefits and risks of HMEs used in conjunction with humidification systems. It is advisable to review the instructions for use provided with the humidification systems and HMEs and the available literature for more details.

1.1.1.4 Devices commonly referred to as "room humidifiers," humidifiers used in heating, ventilation, and air-conditioning systems and humidifiers used to condition the environment within infant incubators are outside the scope of this specification.

1.1.1.5 It has not been found possible to include guidance on the matter of droplet size in the case of nebulizing humidifiers.

1.1.1.6 Gas-powered nebulizers used for the delivery of drugs to patients through their respiratory system are outside the scope of this specification.

1.1.1.7 Appendices in this specification are not mandatory unless made so by an explicit statement in the main text.

1.2 The values stated in SI units are to be regarded as the standard.

Keywords

humidifiers; medical use; active humidification systems; ICS Number Code 11.040.10 (Anaesthetic, respiratory and reanimation equipment); 11.140 (Hospital equipment); 91.140.30 (Ventilation and air-conditioning systems)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)

11.140 (Hospital equipment Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.)

91.140.30 (Ventilation and air-conditioning systems Including ventilation ducts Ventilators and air-conditioners, see 23.120)

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