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ASTM-F1690:2004 Edition

ASTM-F1690:2004 Edition

$44.96

F1690-96(2004) Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems

Published By Publication Date Number of Pages
ASTM 2004 17
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ASTM F1690-96-Reapproved2004

Withdrawn Standard: Standard Specification for Humidifiers for Medical Use—Part 1: General Requirements for Active Humidification Systems (Withdrawn 2013)

ASTM F1690

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 Code

ICS Number Code 11.040.10 (Anaesthetic, respiratory and reanimation equipment)

DOI: 10.1520/F1690-96R04

PDF Catalog

PDF Pages PDF Title
1 Scope
2 Referenced Documents
Terminology
3 Relationship of This Specification to the General Standard

Clauses Containing Amendments, Additions, or Replacements to the Text in IEC 601-1:1988
, and Additional Clauses 60 Through 65

5 (8) Basic Safety Requirements:
(9) Removable Protective Means:
(10) Environmental Conditions:
(13) General
(14) Requirements Related to Classification
(15) Limitation of Voltage or Energy, or Both
(16) Enclosures and Protective Covers
(17) Separation (Previous Title: Insulation and Protective Impedances)
(18) Protective Earthing, Functional Earthing, and Potential Equalization
(19) Continuous Leakage Currents and Patient Auxiliary Currents
(20) Dielectric Strength
(21) Mechanical Strength
(22) Moving Parts
(23) Surface, Corners, and Edges
(24) Stability in Normal Use
6 (25) Expelled Parts
(26) Vibration and Noise
(27) Pneumatic and Hydraulic Power
(28) Suspended Masses
(36) Electromagnetic Compatibility
(37) Locations and Basic Requirements
(38) Marking, Accompanying Documents
(39) Common Requirements for Category AP and Category APG Equipment
(40) Requirements and Tests for Category AP Equipment, Parts, and Components Thereof
(41) Requirements and Tests for Category APG Equipment, Parts, and Components Thereof
(42) Excessive Temperatures
(43) Fire Prevention
(44) Overflow, Spillage, Leakage, Humidity, Ingress of Liquids, Cleaning, Sterilization, and Disinfection
7 (45) Pressure Vessels and Parts Subject to Pressure
(46) Human Error
(47) Electrostatic Charges
(48) Materials in Applied Parts in Contact with the Body of the Patient
(49) Interruption of the Power Supply
(50) Accuracy of Operating Data
(51) Protection Against Hazardous Output
(52) Abnormal Operation and Fault Conditions
8 (53) Environmental Tests
(54) General
(55) Enclosure and Covers
(56) Components and General Assembly
(57) Main Parts, Components, and Layout
(58) Protective Earthing—Terminals and Connections
(59) Construction and Layout
(60) Humidifier Output
(61) Maximum Pressure Drop
(62) Liquid Container
(63) Noise Measurement
9 (64) Temperature Sensors and Temperature Sensor Ports
(65) Humidifier Leakage
Annexes and Appendixes
A1. TEMPERATURE DISPLAY ACCURACY
A1.1
A1.2
A1.3
A1.4
A1.5
A1.6
A1.7
A1.8
A2. SPECIFIC ENTHALPY CALCULATIONS
A2.1
FIG. A1.1
10 A3. HUMIDIFIER OUTPUT CALCULATIONS
A3.1
A3.2
A3.3
A3.4
11 A4. TEMPERATURE SENSORS AND MATING PORTS
A4.1
A4.2 Test Method for Security of Engagement of the Tem-perature Sensors to Mating Ports
A4.3 Test Method for Leakage from Temperature Sensors Engaged in Mating Ports
A5. STANDARD TEMPERATURE SENSOR
A5.1
FIG. A4.1
12 FIG. A5.1
FIG. A5.2
13 X1. RATIONALE STATEMENT
X1.1
FIG. X1.1
15 X1.2
16 REFERENCES

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