Indel B RM7 Instrucciones De Uso página 24

RM7
SAFE T Y
The following paragraph provides a brief description of all the safety regulations followed in the design of
the device. It also describes all the safety precautions to be implemented for the correct use of the device.
G E N E R A L SA FE T Y
The RM7 heater complies with the following regulations:
Directive 93/42/EEC of 14 June 1993: General criteria to be used in the design and construction of certain
categories of medical devices.
Ministerial Decree of 15 November 2005: Approval of models for forms for reporting accidents or near
misses involving medical devices or in-vitro medical devices.
Ministerial Decree of 20 February 2007: New modalities for the measures specified in article 13 of Legislative
Decree no. 46 of 24 February 1997, as amended, for the registration of active implantable devices and their
inclusion in the Directory of medical devices.
Ministerial Decree of 21 December 2009: Amendments and additions to the Decree of 20 January 2007 on
"new modalities for the measures specified in article 13 of Legislative Decree no. 46 of 24 February 1997, as
amended, for the registration of active implantable devices and their inclusion in the Directory 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: Model for quality assurance in design, development, manufacture, installation and
support.
UNI EN ISO 9000:2015: Quality management systems - Fundamentals and Glossary
UNI ENI CEI EN ISO 14971:2012: Medical devices – Application of the risk management to medical devices
CEI EN 60601-1:2007: Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
CEI EN 60601-1-2:2015: Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests.
CEI EN 60601-1-6:2010: Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance - Collateral Standard: Usability.
CEI EN 60601-1-8:2007: Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance – Collateral Standard: Alarm systems.
CEI EN 62304:2015: Medical device software – software life-cycle processes
CEI EN 62353:2015: Medical electrical equipment – Periodic checks and tests to be carried out after repair
of medical electrical equipment.
CEI EN 62366-1:2015: Medical Devices – Part 1: Application of usability engineering to medical devices.
UNI EN 1041:2013: Information supplied by the manufacturer of medical devices
UNI CEI EN ISO 15223:2017: Medical devices – Symbols to be used in medical device labels, labelling and
information to be provided – Part 1: General requirements
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