IEC 60601-2-36:2014 PDF

Scope: Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES@ hereafter referred to as ME EQUIPMENT. 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. This particular standard does not apply to: ?C ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy; ?C ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;

IEC 60601-2-36:2014 Referenced Document

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for basic safety and essential performance of ultrasonic physiotherapy equipment
IEC 61846:1998 Ultrasonics - Pressure pulse lithotripters - Characteristics of fields

2014 IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
1997 IEC 60601-2-36:1997 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy