AS 2684-1984

1 - AS 2684-1984 MEDICAL EQUIPMENT - HUMIDIFIERS FOR MEDICAL USE
4 - PREFACE
5 - CONTENTS
6 - 1 SCOPE.
6 - 2 APPLICATION.
6 - 3 REFERENCED DOCUMENTS.
6 - 4 DEFINITIONS.
6 - 4.1 Absolute humidity
6 - 4.2 Accessible surface temperature
6 - 4.3 Delivery tube
6 - 4.4 Delivery tube heater
6 - 4.5 Delivery tube outlet
6 - 4.6 Humidifier
6 - 4.7 Humidifier heater
6 - 4.8 Humidifier outlet
6 - 4.9 Maximum/ minimum water volume
6 - 4.10 Nebulizing humidifier
6 - 4.11 Operator control
6 - 4.12 Operation indicator
6 - 4.13 Pre-filled
6 - 4.14 Relative humidity
6 - 4.15 Saturated vapour pressure
6 - 4.16 Vaporizing humidifier
6 - 4.17 Humidification chamber
6 - 4.18 Water content (of humidified gas)
6 - 4.19 Water reservoir
6 - 4.20 Breathing system
6 - 4.21 Humidified gas
6 - 4.22 Humidifier tank
6 - 4.23 Steady gas flow
6 - 4.24 Shall, should, may
6 - 5 PERFORMANCE- WATER OUTPUT.
7 - 6 GENERAL DESIGN (INCLUDING MATERIALS AND BIO-COMPATIBILITY.
7 - 6.1 Construction.
7 - 6.2 Condensate drainage.
7 - 6.3 Resistance to gas flow.
7 - 6.4 Sterilization and disinfection.
7 - 6.5 Controls.
7 - 6.6 Surface temperature of accessible parts.
7 - 7 INTERNAL COMPLIANCE.
7 - 8 BREATHING CONNECTIONS.
7 - 8.1 General.
7 - 8.2 Delivery tubes.
8 - 9 HUMIDIFIER CHAMBER AND/OR WATER RESERVOIR.
8 - 9.1 Maximum operating volume.
8 - 9.2 Filling.
8 - 9.3 Water level indicator.
8 - 9.4 Tilting.
8 - 9.5 Water level.
8 - 9.6 Wick assembly.
8 - 9.7 Internal pressure.
8 - 10 TEMPERATURE.
8 - 10.1 General.
8 - 10.2 Normal temperature control.
8 - 10.3 Overtemperature cutout and alarm.
8 - 10.4 Temperature monitor.
8 - 10.5 Calibrated temperature control.
8 - 11 PRESSURE RELIEF.
9 - 12 OPERATOR CONTROLS.
9 - 12.1 Accuracy.
9 - 12.2 Integral oxygen concentration control.
9 - 12.3 Movement of controls.
9 - 12.4 Protection of controls.
9 - 12.5 Legibility of marking.
9 - 13 ELECTRICAL REQUIREMENTS.
9 - 13.1 General.
9 - 13.2 Electrical patient-circuits.
9 - 13.3 Delivery tube electrical circuits.
9 - 13.4 Safety during filling or emptying.
9 - 13.5 Protection against hazards of explosions and fire
9 - 13.6 Electromagnetic radiation.
9 - 14 NOISE LEVELS.
9 - 15 ALARMS.
9 - 15.1 General.
9 - 15.2 Muting of alarms.
9 - 16 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER.
9 - 16.1 General.
10 - 16.2 Humidifier performance.
10 - 17 MARKING.
10 - 17.1 General markings.
11 - 17.2 Electrical ratings and specifications.
11 - 17.3 Instructions.
12 - APPENDIX A - GENERAL TEST CONDITIONS AND APPARATUS REQUIREMENTS
12 - A1 SCOPE.
12 - A2 GENERAL CONSIDERATIONS.
12 - A2.1 Ambient conditions.
12 - A2.2 Test gas.
12 - A2.3 Gas flow.
12 - A2.4 Water container.
12 - A2.5 Test chamber.
12 - A2.6 Analysis of gas concentrations.
12 - A2.7 Test setting combinations.
14 - APPENDIX B - METHOD FOR DETERMINING CONTAINER OVERFLOW
14 - B1 SCOPE.
14 - B2 PRINCIPLE.
14 - B3 APPARATUS.
14 - B4 PROCEDURE.
14 - B4.1 Tilting.
14 - B4.2 Reverse connections.
14 - B5 REPORT.
15 - APPENDIX C - METHOD FOR DETERMINING THE OUTPUT TEMPERATURE
15 - C1 SCOPE.
15 - C2 PRINCIPLE.
15 - C3 APPARATUS.
15 - C4 PROCEDURE.
15 - C5 REPORT.
16 - APPENDIX D - METHOD FOR DETERMINING PRESSURE RELIEF
16 - D1 SCOPE.
16 - D2 PRINCIPLE.
16 - D3 APPARATUS.
16 - D4 PROCEDURE.
16 - D5 REPORT.
17 - APPENDIX E - METHOD FOR DETERMINING THE NOISE LEVELS PRODUCED DURING HUMIDIFIER OPERATION
17 - E1 SCOPE.
17 - E2 PRINCIPLE.
17 - E3 APPARATUS.
17 - E4 PROCEDURE.
17 - E5 REPORT.
18 - APPENDIX F - METHOD FOR DETERMINING WATER OUTPUT
18 - F1 SCOPE.
18 - F2 PRINCIPLE.
18 - F3 APPARATUS.
18 - F4 PROCEDURE.
18 - F5 CALCULATION OF WATER OUTPUT.
18 - F6 REPORT.
19 - APPENDIX G - METHOD FOR DETERMINING INTERNAL COMPLIANCE
19 - G1 SCOPE.
19 - G2 PRINCIPLE.
19 - G3 APPARATUS.
19 - G4 PROCEDURE.
19 - G5 REPORT.
20 - APPENDIX H - METHOD FOR DETERMINING RESISTANCE TO FLOW
20 - H1 SCOPE.
20 - H2 PRINCIPLE.
20 - H3 APPARATUS.
20 - H4 PROCEDURE.
20 - H5 REPORT.
21 - APPENDIX J - METHOD FOR DETERMINING OXYGEN CONCENTRATION
21 - J1 SCOPE.
21 - J2 PRINCIPLE.
21 - J3 APPARATUS.
21 - J4 PROCEDURE.
21 - J5 REPORT.

Specifies minimum performance and safety requirements for humidifiers commonly used in anaesthesia and respiratory care. Two different classes of humidifiers are specified: those intended for use with intubated patients and those for use with patients with intact airways. Performance, general design, internal compliance, breathing connections, requirements for the humidifier chamber and/or water reservoir, temperature of the gas, pressure relief, operator controls, electrical and alarm requirements are laid down. Appendices include methods for determining container overflow, output temperature, water output and oxygen concentration.

This standard specifies requirements for humidifiers commonly used in anaesthesia and respiratory care. It sets out minimum performance and safety requirements for humidifiers and indicates characteristics which should be considered from both of these aspects.

Reconfirmed 1994