Use Instruction
RIMS-IFU-001
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3. Applicable Standards
The device complies with the following international standards.
No.
Standard No.
(Reference document No.)
Title of Standard
1
93/42/EEC as amended by
2007/47/EC
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
2
EN ISO 13485:2016
(ISO 13485:2016)
Medical device – Quality management systems - Requirements for
regulatory purposes
3
EN 60601-1:2006/A1:2013
(IEC 60601-1:2005)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
4
EN 60601-1-2:2015
(IEC 60601-1-2:2014)
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests
5
EN 60601-1-6:2010
(IEC 60601-1-6:2010)
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
6
EN 62366:2008
(IEC 62366:2007)
Medical devices - Application of usability engineering to medical devices
7
EN 62304:2006
(IEC 62304:2006)
Medical device software - Software life-cycle processes
8
EN ISO 14971:2012
(ISO 14971:2007, Corrected
version 2007-10-01)
Medical devices — Application of risk management to medical devices
9
EN 1041:2008
Information supplied by the manufacturer of medical devices
10
EN ISO 15223-1:2016
(ISO 15223-1:2016, Corrected
version 2017-03)
Medical devices — Symbols to be used with medical device labels, labelling
and information to be supplied — Part 1: General requirements
11
EN 301 489-1 V2.2.3 (2019-11)
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services - Part 1: Common technical requirements - Harmonised Standard
for ElectroMagnetic Compatibility
12
EN 301 489-17 V3.2.4 (2020-09)
ElectroMagnetic Compatibility (EMC) standard for radio equipment and
services – Part 17: Specific conditions for Broadband Data Transmission
Systems – Harmonised Standard for ElectroMagnetic Compatibility
13
MEDDEV 2.4/1 rev.9
Classification of medical devices
14
MEDDEV 2.7.1_rev 4
Clinical Evaluation: Guide for manufacturers and notified bodies
15
MEDDEV 2.12/1 rev.8
Guidelines on a Medical Devices Vigilance System
16
MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies