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CONFORMITEITSVERKLARING
ORMESA S.r.l. guarantees and declares, under its own exclusive responsibility, that the following Medical
Device, technical aid for rehabilitation:
STANDING FRAME FOR AN UPRIGHT POSITION
which this declaration refers to, conforms with the general requirements provided in the Directive
93/42/EEC and subsequent amendments and additions, concerning the medical devices, according to
which this aid belongs to the I risk class and has been designed in observance to the following
standards:
UNI CEI EN ISO 14971:2012
UNI EN 12182:2012
ISO 9999:2011
UNI CEI EN ISO 15223-1:2017
UNI EN 1041:2009
EN 60601-1:1993
EN 60601-1-2:1993
EN 55014-1:1994
EN 61000-4-2:1996
EN 61000-4-4:1996
EN 61000-4-5:1996
Foligno, 2019/8/1
STANDY ELECTRO WING
Medical Devices - Application of risk management to
medical device
Technical aids for disabled persons - general requirements and test
methods
Technical aids for persons with disabilities - Classification and
terminology
Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied — Part 1: General
requirements
Information supplied by the manufacture with medical devices.
Medical electrical equipment -- Part 1: General requirements for
basic safety and essential performance
Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
Electromagnetic compatibility - Requirements for household
appliances, electric tools and similar apparatus - Part 1: Emission
Electromagnetic compatibility (EMC)- Part 4-2: Testing and
measurement techniques - Electrostatic discharge immunity test
Electromagnetic compatibility (EMC) - Part 4: Testing and
measurement techniques - Section 4: Electrical fast transient/burst
immunity test. Basic EMC Publication
Electromagnetic compatibility (EMC). Testing and measurement +A
techniques. Surge immunity test
Serial Number (SN):
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