This specification includes requirements for the safety and performance of active vaporizing and nebulizing humidification systems suitable for inclusion in breathing systems (both intubated and nonintubated patients). 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.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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:
18.104.22.168 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).
22.214.171.124 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.
126.96.36.199 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.
188.8.131.52 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.
184.108.40.206 It has not been found possible to include guidance on the matter of droplet size in the case of nebulizing humidifiers.
220.127.116.11 Gas-powered nebulizers used for the delivery of drugs to patients through their respiratory system are outside the scope of this specification.
18.104.22.168 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F1054 Specification for Conical Fittings
F1205 Specification for Anesthesia Breathing Tubes
F1463 Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care
ANSI/CGAG7.1 Commodity Specification for Medical Grade Air Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
CGAPamphletG4.3 Commodity Specification for Medical Grade Oxygen Available from Compressed Gas Association, 1235 Jefferson Davis Highway, Arlington, VA 22202.
ISO10651 Lung Ventilators for Medical Use--Part 3: Particular Requirements for Emergency and Transport Ventilators
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)
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Citing ASTM Standards
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