
Safety Requirements
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Classication:
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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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Medical Electrical Equipment, Part 2: Particular Requirements for Safety - 37 Ultrasonic Medical
Diagnostic and Monitoring Equipment [IEC60601-2-37: 2001 with A1:2004, A2:2005]
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Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007]
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Medical Electrical Equipment, Part 1: General Requirements for Safety [UL60601-1:2003]
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Medical Electrical Equipment - Part 1: General Requirements for Safety [CAN/CSA 22.2
No.601.1-M90:1990, with R2003, with R2005]
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Biological Evaluation of Medical Devices [ISO10993 : 2009]
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Standard Means for the Reporting of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment
[IEC61157:2007]
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