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!