AS/NZS 3200.2.18:1997
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Endoscopic equipment
Specifies requirements for the safety of endoscopic equipment and its interconnections with endoscopically-used accessories. It is based on and reproduced from IEC 60601-2-18:1996 and includes the full technical text of that Standard. An Appendix ZZ specifies additional requirements applicable in Australia and New Zealand.
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AS/NZS 3200.2.18:1997 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY.....
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
*6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
*21 Mechanical strength
22 Moving parts
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE 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 temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
57 MAINS PARTS, components and layout
Appendix D - Symbols on marking
Appendix L - References – Publications mentioned in this standard
Annex AA - Rationale
2 Definitions
3 General requirements
6 Identification, marking and documents
20 Dielectric strength
21 Mechanical strength
42 Excessive temperatures
57 MAINS PARTS, components and layout
APPENDIX ZZ - VARIATIONS TO IEC 601-2-18 FOR APPLICATION IN AUSTRALIA ONLY
Previous versions
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AS/NZS 3200.2.18:1997 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY.....
PREFACE
CONTENTS
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
*6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
*21 Mechanical strength
22 Moving parts
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE 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 temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
57 MAINS PARTS, components and layout
Appendix D - Symbols on marking
Appendix L - References – Publications mentioned in this standard
Annex AA - Rationale
2 Definitions
3 General requirements
6 Identification, marking and documents
20 Dielectric strength
21 Mechanical strength
42 Excessive temperatures
57 MAINS PARTS, components and layout
APPENDIX ZZ - VARIATIONS TO IEC 601-2-18 FOR APPLICATION IN AUSTRALIA ONLY
Previous versions
AS/NZS 3200.2.18:1997
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.