introduction to medical emc tutorialb-dig.iie.org.mx/bibdig2/p14-0270/pdf/workshop/041_3889.pdf ·...

MO-PM-3

Introduction to Medical EMC Tutorial

Session Chair: Darryl P. Ray

Darryl Ray EMC Consulting, LLC

IEEE EMC 2014 -‐ Introduc2on to Medical EMC Tutorial -‐ Darryl Ray EMC Consul2ng, LLC 1

Topics For Today

•  Basics of Medical EMC & IEC 60601-‐1-‐2, 4th Edi:on Darryl P. Ray -‐ Darryl Ray EMC Consul2ng LLC, Carlsbad, CA,USA

•  Tes:ng Considera:ons Harald Buchwald -‐ CSA Group, Strasskirchen, Germany

•  EMC Aspects for Ac:ve Implants Curt Sponberg -‐ Medtronics, Minneapolis, MN, USA

•  ACernoon Break (3:00PM – 3:30PM)


Topics For Today (cont.)

•  Tes:ng Wireless on Medical Devices Greg Kiemel -‐ NWEMC, Hillsboro, OR, USA

•  Risk Management Keith Armstrong -‐ Cherry Clough Consultants, Brocton, United Kingdom

•  An FDA Perspec:ve on EMC of Medical Devices Jeffrey L. Silberberg -‐ Food & Drug Administra2on, Silver Spring, MD, USA

•  Open Panel Discussion – All


Darryl P. Ray

Principal Consultant Darryl Ray EMC Consul:ng, LLC

Carlsbad, CA, USA

darryl.ray@dray-‐emc.com +1-‐925-‐487-‐0072

www.dray-‐emc.com

Basics of Medical EMC

IEEE EMC 2014 -‐ Basics of Medical EMC -‐ Darryl Ray EMC Consul2ng, LLC 4

Overview

•  IEC 60601 series of standards

•  Complying with FDA & EU requirements

•  Worldwide regulatory issues

•  Design challenges

•  What is “Essen:al Performance” & “Basic Safety”


IEC 60601/80601 Series of Standards

•  Safety standards •  Pa:ent •  Operator •  Environment

•  Essen:al Performance covered

•  Over 80 standards & growing

•  80601 = Joint IEC/ISO standard


IEC 60601/80601 Series Hierarchy

Medical Electrical Equipment Standards

•  Par:cular -‐ Product specific (vert.) IEC 80601-‐2-‐X

•  Collateral -‐ Parallel (horizontal) IEC 60601-‐1-‐X

•  General safety standard IEC 60601-‐1

•  Basic standards (e.g. 61000-‐4-‐x)

Precedence


Medical EMC Requirements

•  Requirements are generally per IEC 60601-‐1-‐2:2007

•  EN 60601-‐1-‐2:2007 is equivalent

•  Par:cular standards (IEC 80601-‐2-‐X) may modify levels and acceptance criteria

•  IEC 60601-‐1-‐2 4th edi:on published February 2014


Item US EU Japan Brazil Canada Korea China

Version of 60601-‐1-‐2

3rd Edi:on (IEC)

2007 (EN)

2nd Edi:on (JIS)

3rd Edi:on (IEC)

3rd Edi:on (IEC)

3rd Edi:on (IEC)

3rd Edi:on (YY0505)

Accept Manufacturers Data

yes yes yes no yes yes

no -‐ in country test

required

Lab Accredita:on Required no no no no no no no

CB EMC Report Required no no no no no no no

Unique Test Condi:ons possible possible yes

(100 V) yes

(117/220 V) no Yes (220 V) no

Unique Test Report Requirements

yes – see FDA web

site no no no no no no

Medical EMC Regulatory Requirements by Country

Note: Requirements subject to change – Check with your RA staff for updates IEEE EMC 2014 -‐ Basics of Medical EMC -‐ Darryl Ray EMC Consul2ng, LLC 9

Reading Tips


Small Caps = Defined Term

* = Ra:onale (usually Annex A)

Reading Tips


Complying with FDA Requirements

•  Design controls required per 21CFR

•  Quality requirements – Need detailed design requirements, test plan and report

•  Explain why decisions were made

•  Product compliance required throughout the lifecycle


Complying with FDA Requirements

•  Monitor design changes – retest as required

•  Can it withstand an audit?

•  Unique standards acceptance & report requirements (see FDA web site)


FDA & EU – Dates of Compliance

•  FDA u:lizes a predicate rule – legacy devices may not need to comply with newer standards

•  European Union •  MDD encourages “state of the art”

•  Typical 3 year transi:on period for revised standards •  Actual dates are stated in the Official Journal

•  No:fied Body may specify dates of compliance

•  MDD takes precedence over the EMC direc:ve


What is Essential Performance (EP)?

•  Pertains only to safety performance (freedom From unacceptable risk)

•  Defined by: •  IEC 60601-‐1 edi:on 3.1 •  IEC/ISO 80601-‐2-‐X •  Manufacturers may define using risk analysis

•  Some devices have no essen:al performance •  Relevance: Immunity acceptance criteria is linked to Essen:al Performance (and Basic Safety)


Basic Safety & Essential Performance

From IEC 60601-‐1:2005 + A1:2012

3.27 Essen2al Performance performance of a clinical func:on, other than that related to basic safety where loss or degrada:on beyond the limits specified by the manufacturer results in an unacceptable risk

3.10 Basic Safety freedom from unacceptable risk directly caused by physical hazards when me equipment is used under normal condi:on and single fault condi:on


Essential Performance - Example

From IEC/ISO 80601-‐2-‐72 (DraC)


Basic Safety & Essential Performance

•  Some Devices Do Not Have Specified Essen:al Performance

•  All Devices Must Comply with Basic Safety


Intended & Normal Use Definitions


From IEC 60601-‐1, Edi:on 3.1 3.44 Intended Use use for which a product, process or service is intended according to the specifica:ons, instruc:ons and informa:on provided by the manufacturer 3.71 Normal Use opera:on, including rou:ne inspec:on and adjustments by any operator and stand-‐by according to the instruc:ons for use

Intended & Normal Use Definitions


From IEC 60601-‐1, Edi:on 3.1

NOTE Intended use should not be confused with normal use. While both included the concept of use as intended by the manufacturer, intended use focuses on the medical purpose while normal use incorporates not only the medical purpose, but maintenance, transport, etc. as well

Some Unique Design Challenges

•  Analog circuit suscep:bili:es

•  Leakage current restric:ons

•  Interference from mobile transmirers

•  ESD immunity on connectors

•  I/O ports – safety tes:ng per IEC 60601-‐1


Analog Circuits – Can Be Very Susceptible

•  2Hz modula:on (from 3rd edi:on) is a challenge

•  Many devices have high gain amplifiers

•  Filter amplifiers as much as possible

•  Locate in a shielded region


Leakage Current Restrictions

•  IEC 60601-‐1 2nd Edi:on has low leakage current limits

•  IEC 60601-‐1 3rd Edi:on is less stringent, aligns with IEC 60950 – watch the version!

•  Y-‐capacitor values constrained

•  Select medical grade power supplies


ESD Testing

•  Consider transient suppression on accessible connector pins

•  3rd edi:on allows for connector exemp:on; •  Allowed only if the port cannot be filtered •  Requires labeling & staff training

•  Connector test method differs between IEC 60601-‐1-‐2, 3rd and 4th edi:ons

•  Increased :me between successive pulses allowed


IEC 60601-1-2

•  Applies only to medical electrical equipment and systems

•  Requirements for emissions

•  Requirements for immunity

•  Labeling requirements; •  Device marking •  Accompanying documents


IEC 60601-1-2 3rd Edition

•  Immunity acceptance criteria based on 11 specific pass/fail criteria “as related to Basic Safety & Essen:al Performance”

•  Separa:on of life suppor:ng vs. non life suppor:ng equipment

•  Allow manufacturers to use lower immunity test levels (based only on significant physical, technological or physiological limita2ons)

•  Interpreta:on Sheet (I-‐SH) published in 2010 (clarifies AC input voltage requirements)


Immunity Compliance Criteria 3rd Edition


Declaring Compliance to IEC 60601-1-2

•  All applicable tests must pass

and

•  Labeling requirements apply (suggest using a labeling checklist)


IEC 60601-1-2, 4th Edition

IEEE EMC 2014 -‐ IEC 60601-‐1-‐2, 4th Edi2on -‐ Darryl Ray EMC Consul2ng, LLC 29


Published February 25, 2014

4th Edition Motivation

•  Create safety standard w/ respect to EM disturbances

•  Drawbacks with the 3rd edi:on •  Basic Safety and Essen:al Performance aspects – not adequately addressed

•  Test levels in the current standard are 13+ years old (new EM environments unaccounted for, e.g. cell phones)

• Mobile device usage restric:ons are now generally ignored

•  Devices in the same intended use loca:on meet different immunity levels


The Real World!


4th Edition Philosophy

•  Requirements based on the intended use environment (not the device type)

•  Immunity levels based on the reasonably foreseeable maximum

•  Suscep:bility from mobile transmirers must be addressed


4th Edition Philosophy (cont.)

•  Use Risk Management to tailor requirements

•  Immunity requirements defined by port (like CISPR24)

•  Improve user friendliness of standard •  Use of tables •  Numerous annexes with supplemental informa:on


Changes From 3rd Edition - General

Requirements now based on three use environments; •  Professional Healthcare (hospital & small clinic)

•  Home Healthcare (most loca2ons outside the hospital/small clinic)

•  Special (determined on a case by case basis)


Intended Use Environment Examples


Changes From 3rd Edition - General

•  AC input voltage requirements clarified •  Streamlined to one voltage/frequency (excep2on: Voltage Dips & Interrupts)

•  Regulators may insist on na:onal voltages

•  Tes:ng of I/O ports (SIP/SOPS) clarified

•  The Poten:al Equaliza:on Conductor must be connected during tes:ng – if applicable


Potential Equalization Conductor


Changes From 3rd Edition - Emissions

•  Standby mode should be considered

•  Requirements of CISPR 14-‐1* & CISPR 15 eliminated (*except for switching devices and motors)

•  ITE equipment must meet CISPR 32 (not CISPR 22)

•  X-‐Ray generators allowed 20dB relaxa:on

•  New test: Pa:ent cable common mode emissions (informa2ve)


Changes From 3rd Edition - Immunity

•  Immunity pass/fail criteria is based on Essen:al Performance and Basic Safety only

•  Specific failure arributes from 3rd edi:on eliminated

•  Immunity levels are based on use loca:on (not the device type)



•  Higher immunity levels in some instances

•  Standby mode should be considered

•  ESD; •  Increased ESD test levels •  Modified ESD test method on connectors



•  Transmirer Exclusion Band eliminated (Radiated Immunity Only)

•  Tes:ng on DC input port condi:onally required (Permanent Cables >3m)

•  Provision for test samples damaged during tes:ng

•  Two new immunity tests added



•  New test: Close Field Proximity •  15 Specific test frequencies •  9 V/m to 28 V/m •  Mostly pulse modula:ons •  Future communica:on services should be considered

•  New test: Surge for devices connected to 12V vehicle power



•  Conducted immunity levels increased in some cases

•  Modified Voltage Dips & Interrupts tes:ng

•  Magne:c Immunity test levels significantly increased

•  Ar:ficial Hand tes:ng requirements clarified


Changes From 3rd Edition - Documentation

•  CISPR 11 Class A emissions warning statement (text differs from CISPR 11)

•  Labeling requirements modified (EMC tables deleted)

•  EMC test plan required -‐ recommended content


Changes From 3rd Edition - Documentation

•  EMC test report required -‐ minimum content defined

•  Risk management process – numerous EMC considera:ons required

•  Referenced standards -‐ dated references specified


Phenomenon IEC 60601-‐1-‐2: 3rd Edi:on

IEC 60601-‐1-‐2: 4th Edi:on

Prof. Healthcare Environment

Home Healthcare Environment

ESD 8 kV Air Discharge (max.) 6 kV Contact Discharge

15 kV Air Discharge (max.) 8 kV Contact Discharge

EFT/Burst 2 kV -‐ AC Mains 1 kV -‐ I/O Ports

5 kHz or 100 kHz PRR

2 kV AC Mains 1 kV I/O Ports 100 kHz PRR

Surges (AC Mains) 2 kV 2 kV

Bold = Changes From the 3rd edi4on

Comparison of Immunity Levels



IEC 60601-‐1-‐2: 4th Edi:on



Magne:c Immunity (50/60 Hz) 3 A/M 30 A/M

Conducted Immunity 3 V (0.15-‐ 80 MHz) 10V ISM Bands (Life Support)

3 V (0.15 -‐ 80 MHz)

6 V (ISM Bands)

3 V (0.15 -‐ 80 MHz)

6 V (ISM + Amateur)

Voltage Dips & Interrupts

• UT < 5%, 0.5 periods

• UT = 40 %, 5 periods

• UT = 70%, 25 periods

• UT < 5%, 5 seconds

•  UT = 0%, 0.5 cycle (0, 45, 90, 135, 180, 225, 270 and 315°)

•  UT = 0 %; 1 cycle UT = 70%; 25/30 cycles (@ 0 degrees)

•  UT = 0%; 250/300 cycle


Comparison of Immunity Levels (cont.)



IEC 60601-‐1-‐2: 4th Edi:on



Radiated Immunity

3 V/m -‐ Non Life Support 10 V/m -‐ Life Support 80 MHz – 2.5 GHz

80%@2 Hz (or 1 kHz) AM Modula:on

3 V/m

80 MHz – 2.7 GHz

80%@ 1 kHz

AM Modula:on

10 V/m

80 MHz – 2.7 GHz

80%@ 1 kHz

AM Modula:on

Proximity Field from Wireless Transmirers (New Test)

N/A 9 V/m to 28 V/m

15 specific frequencies




Test Frequency (MHz)

Test Level (Volts/meter)

Modula:on (@ 50% duty cycle)

Communica:on Service

(par2al list)

385 27 18 Hz TETRA 400

450 28 FM (5 kHz devia2on)

GMRS/FRS

710, 745, 780 9 217 Hz LTE

810, 870, 930 28 18 Hz GSM 800

1720, 1845, 1970 28 217 Hz GSM 1800

2450 28 217 Hz RFID

5240, 5500, 5785 9 217 Hz WLAN

Close Field Proximity Test Levels

Based on 0.3m Separa2on Distance



IEC 60601-‐1-‐2: 4th Edi:on



Electrical Transients -‐ Vehicle

12 Volt Powered (New Test)

N/A N/A ISO 7637-‐2 Pulses -‐ 600V max.




Non Patient Connected I/O Ports

•  Related to the use of the port

•  Intended Use – no tes:ng (except ESD)

•  Normal Use – tes:ng is required


ESD Testing on Connectors

Connector Shell Discharge Requirements Connector Usage

Metallic Contact Discharge to Shell Only Intended Use

Non Metallic Air Discharge to Shell & Air Discharge to Pins*

Intended Use & Normal Use

•  if Reachable by the IEC test finger

•  INTENDED USE – Medical purpose use only

•  NORMAL USE – Intended use plus maintenance, standby mode, transport, etc.


Integration with Non Medical Equipment

•  Must not compromise the system Essen:al Performance and Basic Safety

•  Non medical equipment must comply with relevant standards

•  ITE (mul:media) must comply with CISPR 32 (not CISPR 22)


When Do We Have to Comply with the 4th Edition?

United States European Union Other Regions

Legacy Devices; Never*

New Submirals;

June, 2017

All Devices;

Late 2018 (es2mated)

All Devices;

Varies With -‐ The Country** Part 2 Standards

Notes * Per FDA predicate scheme ** Some countries may not presently accept the 4th edi:on


Impact on Legacy Products

•  Retes:ng •  w/ Poten:al Equaliza:on Conductor arached (if applicable)

•  Emissions & immunity tes:ng in standby mode

•  Possible modified immunity pass/fail criteria

•  Modified immunity test requirements per clause 8

•  New Tests – Close Field Proximity & Surge (vehicles)

•  Labeling modifica:ons •  Update Risk Management file – may impact tes:ng


EMC Performance Standard – IEC 60601-4-2

•  Don’t confuse with “Essen:al Performance”

•  Pass/Fail criteria may be more stringent than essen:al performance & basic safety

•  Expected publica:on 2014/2015 – assumes posi:ve vote

•  IEC 60601-‐4-‐2 – regulatory connec:on unclear


The End

Thank You!


introduction to medical emc tutorialb-dig.iie.org.mx/bibdig2/p14-0270/pdf/workshop/041_3889.pdf ·...

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