TECHNICAL PARAMETERS | PAGE 37 OF 38
5.2 APPLICABLE STANDARDS
Name
IEC, MDD
EN, ISO,
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005
EN ISO 60601-1:2007
Medical electrical equipment Part 1: General
requirements for safety 1.Collateral standard: Safety
requirements for medical electrical systems
IEC 60601-1-1:2000
EN ISO 60601-1-1:2001
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance
–
Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-2: 2007 EN ISO 60601-1-2: 2008
Electromagnetic compatibility (EMC) –
Part 3-2: Limits – Limits for harmonic current emissions (equipment input
current
≤
16 A per phase)
IEC 61000-3-2:2005
EN ISO 61000-3-2:2006
Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage
changes, voltage fluctuations and flicker in public low-voltage supply
systems, for equipment with rated current
≤
16 A per phase and not subject
to conditional connection
IEC 61000-3-3:2008
EN ISO 61000-3-3:2009
Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement
techniques - Electrostatic discharge immunity test
IEC 61000-4-2:2008
EN ISO 61000-4-2:2009
Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement
techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 61000-4-3:2008
EN ISO 61000-4-3:2009
IEC 61000-4-4:2004
Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement
techniques - Electrical fast transient/burst immunity test
IEC 61000-4-4-am1
ed2.0:2009
EN ISO 61000-4-4:2005
Electromagnetic compatibility (EMC) - Part 4: Testing
and measurement techniques - Section 5: Surge immunity test
IEC 61000-4-5:2005
EN ISO 61000-4-5:2006
Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement
techniques - Immunity to conducted disturbances, induced by radio-
frequency fields
IEC 61000-4-6:2008
EN ISO 61000-4-6:2009
Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement
techniques - Power frequency magnetic field immunity test
IEC 61000-4-8:2009
EN ISO 61000-4-8:2009
Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement
techniques - Voltage dips, short interruptions and voltage variations
immunity tests
IEC 61000-4-
11:2004
EN ISO 61000-4-11:2005
Interference voltages introduced into the main
CISPR 11:03+A1:A4,
art. 15.1.2
CISPR 11:03+A1:A4, art.
15.1.2
Interfering radiation in the 30 - 1 000 MHz band
CISPR 11:03+A1:04,
art. 5.2.2
CISPR 11:03+A1:04, art.
5.2.2
Medical electrical equipment - Part 1-4: General requirements for safety -
Collateral Standard: Programmable electrical medical systems
IEC 60601-1-4:2000
EN ISO 60601-1-4:2001
Medical devices – Risk analysis
EN ISO 14971:2009
Biological evaluation of medical devices - Part 1:
Evaluation and testing
ISO 10993-1:2009
Biological evaluation of medical devices - Part 10
Tests for irritation and delayed-type hypersensitivity
ISO 10993-10:2002
Clinical investigation of medical devices for human subjects - Part 1:
General requirements
EN ISO 14155-1:2003
MDD 93/42/EEC
The Medical Devices Directive
SOR/98-282
Date of last revision: 08 January 2010
