EN 60601-2-36

Area	Medical technology
title	Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeal induced lithotripsy.
Latest edition	12.1997
ISO	IEC 60601-2-36: 1997

The EN 60601-2-36 titled "Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy " is part of the series of standards EN 60601 .

The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-36 .

The standard is based on the international version IEC 60601-2-36. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-36 , see DIN-VDE standards part 7 .

This supplementary standard regulates general specifications for the safety, tests and guidelines of devices for extracorporeal induced lithotripsy. The purpose is to describe features of the basic safety as well as tests and to give additional instructions for their application.

validity

The German edition 12.1997 has been accepted as a German standard from the date of its publication .

The current version (12.1997) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
No draft has yet been published for use with the 3rd edition of DIN EN 60601-1.

scope of application

These special stipulations apply to the safety of devices for extracorporeally indicated lithotripsy. The applicability of these special specifications is limited to components that are directly necessary for lithotripsy treatment, such as B. (but not exclusively) the pressure pulse generator , the patient positioning system and their interactions with imaging systems and monitoring devices. Other facilities, such as B. Personal computers for treatment planning, X-ray and ultrasound equipment are excluded from this standard as they are covered in other applicable IEC standards.

These special definitions were developed for devices whose purpose is lithotripsy. During its development, however, it was taken into account that it can be used as instructions for other devices whose medical application is based on therapeutically used extracorporeally induced pressure pulses until their own special specifications are available for these devices.

extra information

The following changed requirements are contained in EN 60601-2-36 (extract):

Protection against electric shock
Protection against mechanical hazards
Protection from radiation
Protection against excessive temperatures
Protection against dangerous initial values
construction