AS/NZS 3200.2.18:1997

1 - AS/NZS 3200.2.18:1997 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY.....
4 - PREFACE
6 - CONTENTS
9 - SECTION ONE - GENERAL
9 - 1 Scope and object
10 - 2 Terminology and definitions
12 - 3 General requirements
12 - 4 General requirements for tests
12 - 5 Classification
12 - *6 Identification, marking and documents
14 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 20 Dielectric strength
15 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
15 - *21 Mechanical strength
15 - 22 Moving parts
15 - 25 Expelled parts
16 - 26 Vibration and noise
16 - 27 Pneumatic and hydraulic power
16 - 28 Suspended masses
16 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
16 - 36 Electromagnetic compatibility
16 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
17 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
17 - 42 Excessive temperatures
19 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
20 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
20 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
20 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
20 - 57 MAINS PARTS, components and layout
22 - Appendix D - Symbols on marking
23 - Appendix L - References – Publications mentioned in this standard
24 - Annex AA - Rationale
24 - 2 Definitions
25 - 3 General requirements
25 - 6 Identification, marking and documents
27 - 20 Dielectric strength
27 - 21 Mechanical strength
27 - 42 Excessive temperatures
28 - 57 MAINS PARTS, components and layout
29 - APPENDIX ZZ - VARIATIONS TO IEC 601-2-18 FOR APPLICATION IN AUSTRALIA ONLY

Specifies requirements for the safety of endoscopic equipment and its interconn ections with endoscopically-used accessories. This Standard is to be read in conjunction wit h AS 3200.1.0-1990. It is based on and reproduced from IEC 601-2-18:1996 and include s the full technical text of that Standard. An Appendix ZZ specifies additional requirements applicable in Australia and New Zealand.

Addition:This Particular Standard specifies requirements for the safety of ENDOSCOPIC EQUIPMENT and itsINTERCONNECTION CONDITIONS with ENDOSCOPICALLY-USED ACCESSORIES.NOTE û As the General Standard does not give requirements for the safety of APPLIED PARTS of different MEDICA L ELECTRIC AL EQUI PMENT when used together, this standard gives requirements for specific INTERCONN ECTION CONDI TIONS commonly encountered during the use of ENDOSCOPES.

First published as AS 3200.2.18-1992.
Second edition AS/NZS 3200.2.18:1997.