POLARIS | IFU312EN00
INSTRUCTIONS FOR USE
This document is the property of
CSO Costruzione Strumenti Oftalmici srl.
Any reproduction, even partial, it is prohibited.
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Before using the device check that there is no sign of damages due to
transport or an incorrect storage, that could compromise the correct
functioning of the device.
It is forbidden to reproduce, totally or partially, texts or images
contained in these instructions for use without the written
authorization of the Manufacturer.
The Manufacturer reserves himself the right to modify the contents
of the instructions for use, without notice.
1.3
NORMATIVE REFERENCES
1.3.1
COMMUNITY DIRECTIVES
-
Directive 93/42/EEC and subsequent modifications and
integrations concerning medical devices
-
Directive 2012/19/EU on waste electrical and electronic equipment
(WEEE)
1.3.2
TECHNICAL STANDARDS
-
IEC 60601-1: 2005 + A1:2012 - Medical electrical equipment - Part
1: General requirements for basic safety and essential
performance.
-
EC 60601-1-2:2014 Edition 4 - Collateral Standard: Electromagnetic
disturbances - Requirements and tests.
-
UNI EN ISO 15004-1:2009 - Ophthalmic Instruments. Fundamental
requirements and test methods - Part 1: General requirements
applicable to all ophthalmic instruments.
-
UNI EN ISO 15004-2:2007- Ophthalmic Instruments. Fundamental
requirements and test methods - Part 2: Light hazard protection.
-
UNI CEI EN ISO 14971:2012 - Medical devices. Application of risk
management to medical devices.
1.3.3
QUALITY MANAGEMENT SYSTEMS STANDARDS
-
UNI CEI EN ISO 13845:2016 - Medical devices. Quality management
systems - Requirements for regulatory purposes