Safety Requirements
■ Classifications
− Type of protection against electric shock: Class I
− Degree of protection against electric shock (when the patient is in physical
contact): Type BF or CF applied part
− Degree of protection against harmful ingress of water: Ordinary equipment
− Degree of safety of application in the presence of a flammable anesthetic
material with air or with oxygen or nitrous oxide: Equipment not suitable for
use in the presence of a flammable anesthetic mixture with air or with
oxygen or nitrous oxide.
− Mode of operation: Continuous operation
■
Electromechanical safety standards met
− Medical Electrical Equipment, Part 1: General Requirements for Basic
Safety and Essential Performance IEC 60601-1:2005/A1:2012
− Medical Electrical Equipment, Part 1-2: General Requirements for Basic
Safety and Essential Performance - Collateral Standards: Electromagnetic
Compatibility - Requirements and Tests IEC 60601-1-2:2007
− Medical Electrical Equipment, Part 1-6: General Requirements for Basic
Safety and Essential Performance - Collateral Standards: Usability IEC
60601-1-6:2010
− Medical Electrical Equipment, Part 2-37: Particular Requirements for the
Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic
and Monitoring Equipment IEC 60601-2-37:2007
− Medical Electrical Equipment, Part 1: General Requirements for Safety IEC
60601-1:1988, A1:1991, A2:1995
− Medical Electrical Equipment, Part 1-1: General Requirements for Safety -
Collateral Standards: General Requirements for Medical Electrical Systems
IEC 60601-1-1:2000
− Medical Electrical Equipment, Part 1-2: General Requirements for Safety -
Collateral Standards: Electromagnetic Compatibility - Requirements and
Tests IEC 60601-1-2:2001, A1:2004
− Medical Electrical Equipment, Part 1-4: General Requirements for Safety -
Collateral Standards: Programmable Electrical Medical Systems IEC
60601-1-4:1996, A1:1999
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