
Documentation set
11 Technical specifications
SL 800
11.1 Essential performance
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11 Technical specifications
11.1 Essential performance
The device does not have any essential performance features as
defined in IEC 60601-1.
11.2 Compliance
If modifications not authorized by the manufacturer are made to
the device, this declaration ceases to be valid.
11.2.1 Directives with which the device is compliant
The device complies with the 93/42/EEC Medical Devices Directive
(MDD).
Device class in accordance with the MDD: I
It carries the CE mark.
The product is RoHS-compliant according to Directive 2011/65/EU.
11.2.2 The device meets the following requirements and
standards
• IEC 60601-1-2
• ISO 15004-1
• ISO 15004-2
11.2.3 Device classification
The device is classified as follows:
• Protection class: II
• Ingress protection rating: IP 20
• Group 2 pursuant to ISO 15004-2
• UMDNS No.: 12-281
• Instrument type: B (IEC60601-1)
Содержание SL 800
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