
Safety Requirements
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Classications:
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Type of protection against electrical shock: Class I
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Degree of protection against electrical shock (Patient connection): Type BF equipment
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Degree of protection against harmful ingress of water: Ordinary equipment
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Degree of safety of application in the presence of a ammable anesthetic material with air or
with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a ammable
anesthetic mixture with air or with oxygen or nitrous oxide.
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Mode of operation: Continuous operation
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Electromechanical safety standards met:
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Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential
Performance [IEC 60601-1:2005]
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Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential
Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests [IEC
60601-1-2:2007]
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Medical Electrical Equipment, Part 1-6: General Requirements for Basic Safety and Essential
Performance- Collateral Standard: Usability [IEC 60601-1-6:2006]
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Medical Electrical Equipment, Part 2-37: Particular Requirements for the Basic Safety and
Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC60601-
2-37:2007]
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Medical Electrical Equipment, Part 1: General Requirements for Safety [IEC 60601-1:1988 with
A1:1991 and A2:1995]
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Medical Electrical Equipment, Part 1: General Requirements for Safety – 1 Collateral Standard:
safety Requirement for Medical Electrical Systems [IEC 60601-1-1:2000]
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Medical Electrical Equipment, Part 1: General Requirements for Safety - 2 Collateral Standard:
Electromagnetic Compatibility - Requirements and Test [IEC 60601-1-2:2001, A1:2004]
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Medical Electrical Equipment, Part 1: General Requirements for Safety - 4 Collateral Standard:
Programmable Electrical Medical Systems [IEC 60601-1-4: 1996, A1:1999]
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