AS/NZS 3200.2.21:1994

1 - AS/NZS 3200.2.21:1994 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - INFA
4 - PREFACE
5 - CONTENTS
7 - SECTION ONE - GENERAL
7 - 1 Scope and object
8 - 2 Terminology and definitions
10 - 3 General requirements
11 - 4 General requirements for tests
11 - 6 Identification, marking and documents
13 - SECTION TWO - ENVIRONMENTAL CONDITIONS
13 - 10 Environmental conditions
13 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 - 20 Dielectric strength
14 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
14 - 21 Mechanical strength
14 - 24 Stability in NORMAL USE
15 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
15 - 33* Infra-red radiation
15 - 36 ELECTROMAGNETIC COMPATIBILITY
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 temperature
17 - 43 Fire prevention
18 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
18 - 46 Human errors
19 - 49 Interruption of the power supply
19 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
19 - 50 Accuracy of operating data
21 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
21 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
21 - 54 General
21 - 56 Components and general assembly
24 - SECTION 101 - ADDITIONAL REQUIREMENTS
24 - 101 Alarms
24 - 102 Sound pressure level
25 - 103 Concentration of carbon dioxide
28 - Appendices/Annexes
28 - Appendix L - References – Publications mentioned in this standard
29 - APPENDIX ZZ - VARIATIONS TO IEC 601-2-21 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
30 - Annex AA - General guidance and rationale
36 - Annex BB - BIBLIOGRAPHY

Applies to infant warmers using a radiant heating source. The device is intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infra-red region of the electromagnetic spectrum. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-21:1994.

Addition:This Particular Standard applies to INFANT RADIANT WARMERS as defined in 2.2.101.

First published as Joint Standard AS/NZS 3200.2.21:1994.