SEFAM EcoStar Auto, Руководство для практикующих врачей и поставщиков домашнего ухода

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Technical characteristics EcoStar Info, EcoStar Auto
Standards Compliance
Risks pertaining to this medical equipment were assessed in accordance with the ISO 14971:2007 standard,
specifically with reference to global residual risk.
The EcoStar Info or EcoStar Auto device complies with the following standards:

IEC 60601-1:2005 + Amd1:2012: Medical
electrical
equipment. Part 1: General
requirements for basic safety and essential
performance.

IEC 60601-1-2:2007: Medical electrical
equipment. Part 1: General requirements for
safety. Collateral standard: Electromagnetic
compatibility
– Requirements and tests.

EN ISO 17510-1:2009: Sleep Apnoea Breathing
Therapy.

EN ISO 5356-1:2005: Anaesthetic and
respiratory equipment - Conical connectors.

Council Directive 93/42/EC concerning
medical devices.

European Parliament and Council Directive
2011/65/EU on the restriction of the use
of certain hazardous substances (RoHS) in
electrical and electronic equipment.

European Parliament and Council Directive
2012/19/EU on waste electrical and
electronic equipment (WEEE).
EC marking
EcoStar Info : 2015
EcoStar Auto : 2015