AS 3200.2.19-1992

1 - AS 3200.2.19-1992 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - BABY INCUBATORS (NURSING)
4 - PREFACE
5 - CONTENTS
7 - SECTION ONE - GENERAL
7 - 1. Scope and object
7 - 1.1 Scope
7 - 1.2 Object
7 - 1.3 Particular Standards
7 - 1.5 Collateral Standards
7 - 2. Terminology and definitions
7 - 2.1.5 APPLIED PART
8 - 2.1.101 INCUBATOR
8 - 2.1.102 BABY COMPARTMENT
8 - 2.1.103 AIR CONTROLLED INCUBATOR
8 - 2.1.104 BABY CONTROLLED INCUBATOR
8 - 2.9 Controls and limiting devices
8 - 2.9.101 SKIN TEMPERATURE SENSOR
8 - 2.9.102 SKIN TEMPERATURE
8 - 2.9.103 AVERAGE TEMPERATURE
8 - 2.9.104 CONTROL TEMPERATURE
8 - 2.9.105 INCUBATOR TEMPERATURE
8 - 2.9.106 AVERAGE INCUBATOR TEMPERATURE
8 - 2.10 OPERATION OF EQUIPMENT
8 - 2.10.101 STEADY TEMPERATURE CONDITION
8 - 3. General requirements
8 - 3.6* Addition:
9 - 4. General requirements for tests
9 - 4.5 Ambient temperature, humidity and atmospheric pressure
9 - 4.6 Other conditions
9 - 5. Classification
9 - 6. Identification, marking and documents
9 - 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
9 - 6.3 Addition:
9 - 6.7 Addition:
9 - 6.8 ACCOMPANYING DOCUMENTS
9 - 6.8.2 Instructions for use
10 - 7. Power Input
11 - SECTION TWO - ENVIRONMENTAL CONDITIONS
11 - 10. Special environmental conditions
11 - 10.2.1 Environment
12 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
12 - 20. Dielectric strength
12 - 20.2 Requirements for EQUIPMENT with an APPLIED PART
12 - 20.3 Values of test voltages
12 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
12 - 21. Mechanical strength
13 - 22. Moving parts
13 - 22.2 Amendment:
13 - 23. Surfaces, corners and edges
13 - 24. Stability in NORMAL USE
13 - 24.1 Replacement:
13 - 24.3 Replacement:
15 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
15 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
15 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
15 - 42. Excessive temperatures
15 - 42.1 Amendment:
15 - 42.3 Item 1) replacement:
16 - 43. * Fire prevention
17 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
17 - 44.2 Overflow
17 - 44.3 Spillage
17 - 44.4 Leakage
17 - 44.7 Cleaning sterilization and disinfection
18 - 45. Pressure vessels and parts subject to PRESSURE
18 - 46. Human errors
18 - 49. Interruption of the power supply
18 - 49.2 Replacement:
18 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
18 - 50. Accuracy of operating data
21 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
21 - 54. General
21 - 55. ENCLOSURES and covers
21 - 56. Components and general assembly
22 - 56.6 Temperature overload control devices
23 - SECTION ELEVEN - ADDITIONAL REQUIREMENTS
23 - 101. Alarms
24 - 102. Sound pressure level
25 - 103. Humidifying unit
25 - 104. Maximum air velocity in the enclosure
25 - 105. Concentration of carbon dioxide (CO2 )
29 - Annexes
29 - Appendix L - References - Publications mentioned in this standard
30 - Annex AA - General guidance and rationale
35 - APPENDIX LL - REFERENCES-PUBLICATIONS MENTIONED IN THIS STANDARD
35 - APPENDIX TT - TOLERANCES FOR APPLICATION IN AUSTRALIA
36 - APPENDIX ZZ - AMENDMENTS TO IEC 601-2-19 FOR APPLICATION IN AUSTRALIA

Specifies requirements for baby incubators in which the air temperature is automatically controlled by a temperature sensor close to the value set by the user. The Standard does not apply to incubators used for the transportation of infants, or to incubators in which heating is provided by means of radiant heat sources. This Standard is to be read in conjunction with AS 3200.1.0-1990, and is technically equivalent to IEC 601-2-19:1990.

Addition:This Particular Standard specifies safety requirements for INCUBATORS, as defined in 2.1.101 of this standard.This standard does not apply to transport incubators used for the transportation of babies (see IEC 601-2-20).

Amendment 1 to AS 3200.2.19-1992 see DR 98480 First published as part of AS 3201.2-1971.Revised and redesignated in part as AS 3200.2.19-1992. First published as part of AS 3201.2-1971. Revised and redesignated in part as AS 3200.2.19-1992.