IEC 60601 Family of Standards with an emphasis on IEC 60601-1 3rd Edition

Jeffrey A. Lenk, President Professional Testing (EMI), Inc.

www.ptitest.com | 800.695.1077 | jlenk@ptitest.com

Presentation Overview Introduction

Standard Definitions

Transition & Dates from IEC 60601-1 2nd to 3rd edition

IEC 60601-1 3rd Edition highlights

ISO 14971 Risk Management

Collateral & Particular Standards

IEC 60601-1-2 EMC Requirements

Other Considerations such as Reliability

Introduction

IEC 60601-1 (2nd Edition) - published in 1988 is being replaced by:

IEC 60601-1 (3rd Edition) - published in 2005

Points of interest: ◦ New related collateral and particular standards ◦ “New Philosophy”

Risk Management Essential Performance

◦ New or modified changes in technical requirements

Definitions General Standard – Designated as IEC 60601-1. This standard is applicable to all devices that fall under the Medical Electrical Equipment definition of IEC 60601-1.

Medical Electrical (ME) Equipment – ME Equipment is electrical equipment having an Applied Part or transferring energy to or from the Patient or detecting such energy transfer to or from the Patient and which is:

a) provided with not more than one connection to a particular Mains Supply; and

b) intended by its Manufacturer to be used:

1) in the diagnosis, treatment, or monitoring of a Patient; or

2) for compensation or alleviation of disease, injury or disability

Collateral Standards – Designated as IEC 60601-1-X. These standards specify general requirements applicable to a subgroup of Medical Electrical Equipment or a specific characteristic of ME Equipment that is not fully addressed in the general standard.

Particular Standards – Designated as IEC 60601-2-X. These are standards that are specific to a particular device type. Not all devices will have a particular standard that is applicable to them.

Transition Dates – IEC 60601-1 3rd Edition European Union (EU) General Standard June 1, 2012

European Union (EU) particular Standards Varies*

Canada General Standard June 1, 2012

Canada Particular Standards Varies*

United States (FDA) July 1, 2013

Brazil January 1, 2014

Japan Published June 1, 2012 (Transition potentially 2017)

Other Countries TBD

* Subject to various dates published in official Journal of EU for EU and 3 year transition from publication date for Canada

IEC 60601-1 3rd Edition Highlights

Risk management – most significant change Interaction between Manufacturer and Test Lab is much

greater

Specific standard requirements with results listed in TRF

Risk Management – 2nd Edition

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IEC 60601-1 3rd Edition Highlights

Essential Performance – New Philosophy

Essential Performance (EP) is defined as the performance necessary to achieve freedom from unacceptable risk(s)

Essential Performance is most easily understood by considering whether its absence or degradation would result in an unacceptable risk

The manufacturer’s EP requirements may vary from the standard, depending on the proposed use of the device

All applicable fault condition testing cannot be identified without identifying EP in the risk management file

IEC 60601-1 3rd Edition Highlights

New Collateral (-1’s) There are currently six collateral standards published

IEC 60601-1-1….-8

New Particular Standards (-2’s) There are currently 44 particular standards published

IEC 60601-2-1….-66

**Use Older -1’s and -2’s until aligned with 3rd edition

IEC 60601-1 3rd Edition Highlights

Clause by Clause review of IEC 3rd Edition

Or for an electronic copy: Scan this QR code with your mobile device

(you can go to your app store to download a free QR code reader)

Or go to http://www.ptitest.com/wp-content/uploads/IEC-60601-1-3rd-Edition-Clause-Review-Handout.pdf

See Separate Handout

IEC 60601-1-2:2007 EMC Requirements RF Emissions (Conducted and Radiated) CISPR 11 Group 1 or 2, Class A or B

Harmonic Emissions IEC 61000-3-2 Class A, B, C, D or N/A

Voltage Fluctuations IEC 61000-3-3 Complies or N/A

Electrostatic Discharge (ESD) IEC 61000-4-2 ±6kV Contact Discharge ±8kV Air Discharge

Electrical Fast Transient (EFT) IEC 61000-4-4 ±2kV Power ±1kV I/O’s

Surge IEC 61000-4-5 ±1kV Line to Line ±2kV Line to Earth

Voltage Dips and Drops IEC 61000-4-11 <5% for 0.5 Cycles 40% for 5 Cycles 70% for 25 Cycles <5% for 5 Sec

Magnetic Immunity IEC 61000-4-8 3A/m

Conducted RF Immunity IEC 61000-4-6 3Vrms (Outside ISM Bands or Non-Life Support Equipment) 10Vrms (Inside ISM Bands for Life Support Equipment)

Radiated RF Immunity IEC 61000-4-3 10V/m Life Support Equipment 3V/m Non-Life Support Equipment

** IEC 60601-1-2 requires inclusion of EMC test results in the product documentation

Other Considerations – Reliability Testing

Don’t stop your testing program short by not considering reliability and extending the life of the product…

Environmental - Temperature & Humidity

Vibration - Operational & non-operational (transportation)

Ingress Protection (IPXX)

Highly Accelerated Life Testing (HALT)

Mean Time Between Failure (MTBF)

Thank You!

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