AS/NZS 3200.2.21:1994
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Infant radiant warmers
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. It is supplementary to AS 3200.1-1990/NZS 6150:1990 Approval and test specification - Medical electrical equipment, Part 1: General requirements for safety. This standard is identical to and reproduced from IEC 60601-2-21:1994.
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AS/NZS 3200.2.21:1994 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - INFA
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
24 Stability in NORMAL USE
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
33* Infra-red radiation
36 ELECTROMAGNETIC COMPATIBILITY
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperature
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
46 Human errors
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
SECTION 101 - ADDITIONAL REQUIREMENTS
101 Alarms
102 Sound pressure level
103 Concentration of carbon dioxide
Appendices/Annexes
Appendix L - References – Publications mentioned in this standard
APPENDIX ZZ - VARIATIONS TO IEC 601-2-21 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
Annex AA - General guidance and rationale
Annex BB - BIBLIOGRAPHY
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AS/NZS 3200.2.21:1994 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY - INFA
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
10 Environmental conditions
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
24 Stability in NORMAL USE
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
33* Infra-red radiation
36 ELECTROMAGNETIC COMPATIBILITY
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperature
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
46 Human errors
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
56 Components and general assembly
SECTION 101 - ADDITIONAL REQUIREMENTS
101 Alarms
102 Sound pressure level
103 Concentration of carbon dioxide
Appendices/Annexes
Appendix L - References – Publications mentioned in this standard
APPENDIX ZZ - VARIATIONS TO IEC 601-2-21 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
Annex AA - General guidance and rationale
Annex BB - BIBLIOGRAPHY
AS/NZS 3200.2.21:1994
Online Library subscription information
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