AS 3200.2.5-1992

1 - AS 3200.2.5-1992 APROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-ULTRASONIC....
4 - PREFACE
5 - CONTENTS
6 - SECTION ONE - GENERAL
6 - 1. Scope and object
6 - 2. Terminology and definitions
7 - 3. General requirements
8 - 4. General requirements for tests
8 - 5. Classification
8 - 6. Identification, marking and documents
9 - 7. Power input
9 - SECTION TWO - ENVIRONMENTAL CONDITIONS
9 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
9 - 13. General
9 - 14. Requirements related to classification
9 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
9 - 21. Mechanical strength
10 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
10 - 35. Acoustical energy (including ultrasonics)
10 - 36. Electromagnetic compatibility
10 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
10 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
10 - 42. Excessive temperatures
11 - 43. Fire prevention
11 - 44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
12 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
12 - 50. Accuracy of operating data
12 - 51. Protection against hazardous output
13 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
13 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
13 - 56. Components and general assembly
17 - APPENDIX AA - RATIONALE
19 - APPENDIX BB - TESTING DURING MANUFACTURE AND/OR INSTALLATION
19 - APPENDIX LL - REFERENCES -PUBLICATIONS MENTIONED IN THIS STANDARD
19 - APPENDIX ZZ - AMENDMENTS TO IEC 601.2.5 FOR APPLICATION IN AUSTRALIA

Specifies the safety requirements for ultrasonic therapy equipment used in medical practice togenerate and apply ultrasound to a patient for therapeutic purposes. This Standard does not apply to equipment in which a tool is driven by ultrasound, or in which focused ultrsoubd pulse waves are used to destroy conglomerates. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-5:1984.

This clause of the General Standard applies except as follows:Addition:This Particular Standard specifies the requirements for safety of ULTRASONIC THERAPY EQUIPMENT used in medical practice, as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT.This Particular Standard does not apply to EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry) or in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites).

First published as part of AS 3201.1-1971.
Revised and redesignated in part as AS 3211-1986.
Revised and redesignated AS 3200.2.5-1992.