| IFU327EN00 - 01/2021
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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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 devices
-
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.
-
UNI EN ISO 19980:2012 - Ophthalmic instruments - Corneal
topographs
1.3.3
QUALITY MANAGEMENT SYSTEMS STANDARDS
-
UNI CEI EN ISO 13485:2016 “Medical devices. Quality management
systems - Requirements for regulatory purposes”.