M00004601
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Approval and test specification - Medical electrical equipment Particular requirements for safety - Extracorporeally induced lithotripsy
Standards Australia
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Availability date: 10/27/2021
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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | Standards Australia |
ProductNote | Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn. |
Pages | |
ISBN | |
Committee | HE-003 |
Supersedes |
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