EN 60601-2-18
DIN EN 60601-2-18 | |
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Area | Medical technology |
title | Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment |
Latest edition | 12.2001 |
ISO | IEC 60601-2-18: 1996 + A1: 2000 |
The EN 60601-2-18 with the title "Medical electrical devices - Part 2-18: Special provisions for the safety of endoscopic devices" is part of the EN 60601 series of standards . The German Institute for Standardization is the publisher of the DIN standard DIN EN 60601-2-18 .
The standard is based on the international version IEC 60601-2-18. Within the framework of the VDE standards, the standard is classified as VDE 0750-2-18 , see DIN-VDE standards part 7 .
This supplementary standard regulates general requirements for the safety, tests and guidelines of endoscopic devices.
validity
The German edition 12.2001 is accepted as a German standard from the date of its publication .
- The current version (12.2001) is to be used in accordance with the 2nd edition of DIN EN 60601-1 .
- In June 2008, a draft for use with the 3rd edition of DIN EN 60601-1 was published.
- The previous standard DIN EN 60601-2-18: 1997-09 was allowed to be used until August 2003.
scope of application
These special stipulations place demands on the safety of endoscopic devices and their connections with accessories that can be used endoscopically.
Since the general stipulations do not specify any requirements for the safety of jointly used application parts of different medical electrical devices, these special stipulations place requirements on the specific connections that are usually found when using endoscopes.
extra information
The following changed requirements are contained in EN 60601-2-18 (extract):
- Dielectric strength
- Temperatures
- Compatibility HF surgery
- cleaning