Biocompatibility; Literature - GE Medical Systems MAC 1200 Operator's Manual

Biocompatibility

Literature

Revision B
The Basics: 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.
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.
MAC 1200
2012250-022
1-13