Revision C MAC 1200/1200 ST 1-11
2012250-021
The Basics: Biocompatibility
Biocompatibility
The parts of the product described in this operator manual, including all
accessories, that come in contact with the patient during the intended
use, fulfill the biocompatibility requirements of the applicable standards.
If you have questions in this matter, please contact GE Medical Systems
Information Technologies or its representatives.
Literature
Medical Device Directive of August 2, 1994
EN 60601-1: 1990 + A 1: 1993 + A 2: 1995
Medical electrical equipment. General requirements for safety.
EN 60601-1-1: 9/1994 + A1: 12/1995
General requirements for safety. Requirements for the safety of medical
electrical systems.
IEC-Publication 513/1994: Fundamental aspects of safety standards for
medical equipment.
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