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Electrical Equipment in Medical PracticeSteve HayesGeneral Manager
IEC 60601-1-2:2014 - What‘s new?
“Electromagnetic Compatibility” replaced to be in line with philosophy of IEC 60601-1
IEC 60601-Series of Standards: Structure
Products need to apply:
IEC 60601-1-XCollateral Standards
(for classes of products)
IEC 60601-2-XParticular Standards
(for specific products)
IEC 60601-1 Medical Electrical EquipmentPart 1: General requirements for basic safety and essential performance
Part 2: Particular requirements for basic safety and essential performance … of about 70 product families
e.g. CT, MR, endoscopic-, ultrasonic equipment
-1-2: Electromagnetic Compatibility -1-3: Radiation Protection -1-6: Usability-1-8: Alarms-1-9: Environment-1-10: Physiological Closed-Loop Controllers-1-11: Home Healthcare Environment-1-12: Emergency Medical Services Environment
a) the -1 b) all applicable Collateral’s c) all applicable Particular’s which all have to belong to the same edition of the -1
Risk Management
Risk Evaluation
Risk Evaluation of
the overall residual risk acceptability
Risk Management
report
Production & post
production information• Intended use
and identification of safety relating to medical device
• Hazard ID• Estimation of
risk for each hazard ID
Risk Analysis
• Risk control option analysis
• Implementation of the control measures
• Residual risk evaluation
• Risk/benefit analysis
• Risks arising from the control measures
• Completeness of the risk control
Risk Control
Risk AssessmentRisk Management
Function of IEC 60601-1-2 in the Risk Management ProcessIEC 60601-1:
Basic Safety and Essential Performance
ISO 14971Risk Management
Shock risks
Fire risks
Mechanical risks
Risks caused byelectromagneticdisturbances
Risks caused byclimatic conditions
Risks from misuse
Etc.
Ris
k M
anag
emen
t File
Mitigation Methods- Bonding- Filtering- Shielding- Galvanic isolation- Overvoltage
Protection- etc.
EMC design techniques(for hardware and software)
EMC test methods
Electromagneticenvironments
IEC 60601-1-2 IEC 60601-1-2EM Risk analysis
EM Risk evaluation
EM Risk controlUsing verification andvalidation methods such as:- Demonstrations- Checklists- Inspections- Reviews & assessments- Independent reviews and
assessments- Audits- Non-standardized checksand tests
- individual and/or integratedhardware tests
- Computer simulation- EM testing
EM Risk management report
EM Risk acceptability
EM Production and post-production information
Example of risk control
125kHz
Gap
Harmonised Standard
Limit
150kHz
Electromagnetic Safety v Compatibility
What is Basic Safety v Essential Performance?
BASIC SAFETYfreedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION
ESSENTIAL PERFORMANCEperformance necessary to achieve freedom from unacceptable RISKNOTE ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradationwould result in an unacceptable RISK.
EM Basic Safety v Essential Performance230v
An example – medical diagnostic PC
• Core i7• 4k graphics• BTLE• Ethernet• WiFi
What environment has it designed for?
Wireless Medical Products
Radio Equipment Directive Medical Devices Directives
Article 3.1(a) safety
Article 3.1(b) EMC Article 3.2 radio
Emissions N/A EN 301 489 - xEN 303 446 - x
ETSI EN radio standard(s)
EN 60601-1-2 Clause 7
Immunity Risk Assessment
EN 301 489-xEN 303 446 - x N/A EN 60601-1-2
Clause 8
Medical v Radio EMC Standards
Basic Test Standard IEC 60601-1-2:2014 ed. 4 EN 301 489-x
IEC/EN 61000-4-2:2009 – Electrostatic Discharge Immunity x x
IEC/EN 61000-4-3:2006 +A1:2008 +A2:2010 – Radiated RF Immunity x x
IEC/EN 61000-4-4:2012 – Electrical Fast Transients Immunity x x
IEC/EN 61000-4-5:2014 – Voltage Surge Immunity x x
IEC/EN 61000-4-6:2014 – Conducted RF Immunity x x
EN 61000-4-8:2010 – Power Frequency Magnetic Field Immunity x x
EN 61000-4-11:2004 – Voltage Dips and Short Interruptions Immunity x xISO 7637-2:2011 – Voltage Transients and Surges for Equipment used in a vehicular environment x x
EN 55011:2009 +A1:2010 – Radiated Emissions x xEN 55011:2009 +A1:2010 – Conducted Emissions x xRTCA/DO160G Section 21 Category M – Conducted and Radiated Emissions for Equipment used in an aircraft environment x
EN 61000-3-2:2014 – Harmonic Current Emissions x xEN 61000-3-3:2013 – Voltage Fluctuations and Flicker x x
Changes from Edition 3 to Edition 4 (II) (Examples)
3 environmental categories with corresponding phenomena and test levels are defined:a. HOME HEALTHCARE ENVIRONMENTb. Professional healthcare facility environmentsc. Special (specification of test levels based on process in Annex E)
Test levels represent the reasonably foreseeable maximum level of ELECTROMAGNETIC DISTURBANCES in the environments of INTENDED USE for category a. and b.
Definition of a process which allows for special environments to adopt the specific test level (Annex E)
Special Environments
Industrial Commercial
Emissions Comparison
Domestic Commercial
Aircraft – Categories B-L
Leve
ls
Frequency
More stringent limits with
wider frequency
range
Aircraft – Categories B-L (radiated)
Aircraft – Categories B-L (conducted)
Industrial Commercial (radiated)
Susceptibility Comparison
Domestic Commercial (radiated)
Industrial Commercial (conducted)Domestic
Commercial (conducted)
Leve
ls
Frequency
More severe limits with
wider frequency
range
Radiated Immunity – Wireless Comms Freq’s
Test Frequency (MHz) Modulation Test Level (V/m)385 Pulse Modulation18 Hz 27450 FM 5 kHz Deviation, 1 kHz sine wave 28710 Pulse Modulation 217 Hz 9745 Pulse Modulation 217 Hz 9780 Pulse Modulation 217 Hz 9810 Pulse Modulation 18 Hz 28870 Pulse Modulation 18 Hz 28930 Pulse Modulation 18 Hz 281720 Pulse Modulation 217 Hz 281845 Pulse Modulation 217 Hz 281970 Pulse Modulation 217 Hz 282450 Pulse Modulation 217 Hz 285240 Pulse Modulation 217 Hz 95500 Pulse Modulation 217 Hz 95785 Pulse Modulation 217 Hz 9
Changes from Edition 3 to Edition 4 (III) (Examples)
Test levels are higher for some phenomena: ESD Conducted disturbances induced by RF fields (HAM radio -, ISM - bands) RATED power frequency magnetic fields
(It is not so easy to compare it to edition 3 because other compliance criteria (basic safety and essential performance) are valid!)
Considers new phenomena Immunity against RF transmitters in close proximity (mobile phones, WiFi,
RFID, etc.) Considers modulation characteristics Test procedure according IEC 61000-4-3 as interim solution till specific
procedure is developed by SC77B (planned IEC 61000-4-39).
Changes from Edition 3 to Edition 4 (IV) (Examples)
Describes procedures to continue testing, if EUT reacts (chapt. 8.1). “Standby mode” should be considered Attachment of POTENTIAL EQUALIZATION CONDUCTOR and of all tubing and filling of all fluid
containers Requirements for minimum contents of test reports Is in line with requirements from IEC 60601-1 according to “EXPECTED SERVICE LIFE” AC input voltage requirements clarified for all tests
Compliance Check
Clarifies the tasks of EMC test laboratories
“EMC-Requirements” (in the sense of Performance)?
“ELECTROMAGNETIC COMPATIBILITY
(EMC performance)”, was removed from
FDIS of IEC 60601-1-2 is as separate
Technical Report (TR)
(IEC 60601-4-2 was published in 2016).
IEC 60601-1-2 edition 4 – Time Schedule
2014-02 date of publication
2014-06 FDA recognized with exceptions
2019-02 end of stability period
Europe
2015-02 DOP of EN 60601-1-2:20152018-12 DOC of EN 60601-1-2:2015
(EN61601-1-2:2007 can be used until this date)
Thank you for yourattention!
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