Indel B FM7 BACK Instrucciones De Uso página 28

FM 7
SAFE T Y
The following paragraph lists a short description of all the safety standards adopted while designing the
device. Also, all safety precautions to be taken during use are described as well, for a proper use of the device.
G E N E R A L SA FE T Y
The refrigerator FM7 complies with the following standards:
Directive 93/42/EEC dated 14 June 1993: General criteria regarding design and construction of some
categories of medical devices.
DM 15 November 2005: Approving the templates for the information cards in case of accidents or missed
accidents involving medical devices or medical devices in vitro.
DM 20 February 2007: New modes for the requirements stated in art. 13 of the legislative decree 24 February
1997, no. 46 e following amendments and for the registration of the active implantable devices and the
transcription in the List of medical devices.
DM 21 December 2009: Changes and integration to the Decree 20 February 2007 containing "New modes for
the requirements stated in art. 13 of the legislative decree 24 February 1997, no. 46 e following amendments
and for the registration of the active implantable devices and the transcription in the List of medical devices.
MedDev 2.4/1 rev. 9 June 2010: Classification of medical devices.
MedDev 2.7/1 rev. 4 June 2016: Clinical evaluation: a guide for manufacturers and notified bodies.
MedDev 2.12 rev. 8 January 2013: Guidelines on a Medical Devices Vigilance System
UNI EN ISO 9001:2015: Template for quality assurance during design, development, manufacture,
installation and service.
UNI EN ISO 9000:2015: Quality management systems – Fundamentals and vocabulary
UNI ENI CEI EN ISO 14971:2012: Medical devices – Application of the risk management to medical devices.
CEI EN 60601-1:2007: Electro medical equipment – Part 1: General prescriptions about the fundamental
safety and the essential performance.
CEI EN 60601-1-2:2015: Electro medical equipment - Part 1: General prescriptions about the fundamental safety
and the essential performance - Collateral standard Electromagnetic compatibility - Prescriptions and proofs
CEI EN 60601-1-6:2010: Electro medical equipment - Part 1: General prescriptions about the fundamental
safety and the essential performance - Collateral standard Usability
CEI EN 60601-1-8:2007: Electro medical equipment – Part 1: General prescriptions about the fundamental
safety and the essential performance – Collateral standard Alarm systems.
CEI EN 62304:2015: Medical device software – software life-cycle processes.
CEI EN 62353:2015: Electro medical equipment – Periodical checks and tests to be done after the repair of
an electro medical equipment.
CEI EN 62366-1:2015: Electro medical devices – Part 1: Application of the engineering to the usability of the
medical devices.
UNI EN 1041:2013: Information supplied by the manufacturer together with the medical devices.
UNI CEI EN ISO 15223:2017: Medical devices – Symbols to be used in the labels of the medical device, in the
labelling and in the information that must be supplied with it– Part 1: General requirements
FM7 REV. 01 - FEBRUARY 2019
26