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Device classification according to the standards and relative limits of use
Classification according to EN 60601-1 (2006) and EN 60601-1-2 (2007) regarding medical
electrical devices and EN ISO 10079-1 (2009) “Medical suction equipment - Part 1: Electrically
powered suction equipment - Safety requirements”
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Definition:
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Mobile/portable device
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Device for continuous operation
Classification according to EN 60601-1-11 (2010) regarding medical electrical devices used in a
domestic environment
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Definition:
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Transit-operable/body-worn
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Electrical hazards/protection against electric shock
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Class II medical electrical equipment
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Medical electrical equipment powered by an internal electric source
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Degree of protection against contacts
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Device with applied part type BF
considered over the entire surface of the device
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Protection against hazardous penetration of solid bodies and water
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Device with IP22 degree of protection
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IP40 degree of protection limited solely to the power supply/battery charger provided
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Sterilization methods
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Device NOT to be sterilized
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Possibility of use in an oxygen-rich environment
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Device not to be used in an oxygen-rich environment
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Device not to be used in the presence of flammable substances or agents
Classification according to MDD 93/42/EEC and MDD 2007/47/EC regarding medical devices
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Class IIb device
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The device has passed the tests (where applicable) as required by the following standards:
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EN 60601-1 (2006): “Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance”
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EN 60601-1-2 (2007): “Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests”
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EN ISO 10079-1 (2009): “Medical suction equipment - Part 1: Electrically powered suction
equipment - Safety requirements”
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EN 60601-1-8 (2007): “Medical electrical equipment - Part 1-8: General requirements for basic
safety and essential performance - Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems"
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EN 60601-1-11 (2010): “Medical electrical equipment - Part 1-11: General requirements for basic
safety and essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment”.
