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 information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.