AS/NZS 3200.2.36:1998

1 - AS/NZS 3200.2.36:1998 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR ....
4 - PREFACE
6 - CONTENTS
7 - INTRODUCTION
9 - 1 Scope and object
9 - 1.1 Scope
9 - 1.2 Object
9 - 1.3 Particular Standards
10 - 2 Terminology and definitions
10 - 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
10 - 2.1.101 EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY
10 - 2.12 Miscellaneous
10 - 2.12.101 LITHOTRIPSY
10 - 2.12.102 EXTRACORPOREALLY INDUCED LITHOTRIPSY
11 - 2.12.103 PRESSURE PULSE
11 - 2.12.104 PRESSURE PULSE COUPLING
11 - 2.12.105 FOCAL VOLUME
11 - *2.12.106 LOCALIZATION DEVICE
11 - 2.12.107 TARGET LOCATION
11 - 2.12.108 POSITIONING DEVICE
11 - 2.12.109 TARGET MARKER
11 - 6 Identification, marking and documents
11 - 6.3 Marking of controls and instruments
11 - 6.3.101 Wireless remote control
11 - 6.8 ACCOMPANYING DOCUMENTS
11 - 6.8.2 Instructions for use
12 - *6.8.3 Technical description
12 - 10 Environmental conditions
12 - 10.2.1 Environment
13 - 19 Continuous leakage currents and patient auxiliary currents
13 - 19.1 General requirements
13 - 19.3 Allowable values
13 - 20 Dielectric strength
13 - 20.3 Values of test voltages
13 - 21 Mechanical strength
13 - 21.3 Addition:
14 - *21.3.101 Safety factor
15 - 21.6 PORTABLE and MOBILE EQUIPMENT shall withstand the stress caused by rough handling.
15 - 22 Moving parts
15 - 22.3 Addition:
16 - 22.4 Addition:
16 - 22.7 Addition after the fifth dash:
16 - 24 Stability in normal use
16 - *26 Vibration and noise
17 - 28 Suspended masses
17 - 28.1 General
17 - 28.3 Addition after the second dash
17 - *35 Acoustical energy (including ultrasonics)
17 - *36 Electromagnetic compatibility
18 - 42 Excessive temperatures
18 - 49 Interruption of the power supply
18 - 49.2 Restoration of power supply
18 - 50 Accuracy of operating data
19 - 51 Protection against hazardous output
19 - 54 General
19 - 54.3 Inadvertent changing of settings
20 - 56 Components and general assembly
20 - 56.11 Cord-connected hand-held and foot-operated control devices
20 - 57 Main parts, components and layout
20 - *57.10 CREEPAGE DISTANCES and AIR CLEARANCES
21 - Annexes
21 - Appendix L - References - Publications mentioned in this Standard
22 - Annex AA - General guidance and rationale

Specifies safety requirements for the design and manufacture of devices (lithotripters) intended to generate acoustic pulses from outside the human body for the purpose of fragmenting calculi ('stones') within the body. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 60601-2-36:1997.

This clause of the General Standard applies except as follows: 1.1 Scope Addition:This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this Standard, because they are treated in other applicable IEC standards. While this Particular Standard has been developed for EQUIPMENT intended for use in LITHOTRIPSY, it has been developed such that, as long as no other specific standards are available to be used for other medical applications of therapeutic extracorporeal PRESSURE PULSE equipment, this Standard may be used as a guideline.

First published as AS/NZS 3200.2.36:1998.